CLAIRITY BREAST Indications, Contraindications, Warnings, Precautions, and Other Information
Caution: U.S. Federal law restricts this device to sale by or on the order of a health care provider licensed by the law of the State in which he/she practices.
INDICATIONS FOR USE
The Clairity CLAIRITY BREAST software device is intended to generate a 5-year risk prediction of breast cancer based on a bilateral screening mammogram. CLAIRITY BREAST provides a prediction of the percentage probability that the individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram, through analysis of mammography features and characteristics.
Eligible patients do not have a known breast cancer at presentation for their screening mammogram.
CLAIRITY BREAST is not intended to diagnose or detect breast cancer, or to provide care recommendations. CLAIRITY BREAST is not intended to replace or to be used as the sole determinant for clinical decision-making. CLAIRITY BREAST output is intended to be considered after the radiologist has completed the interpretation of the screening mammogram.
CLAIRITY BREAST analyzes full-field digital mammograms or directly acquired 2D images from Hologic Lorad Selenia and Selenia Dimensions Mammography Systems; it does not analyze synthetic 2D images.
CONTRAINDICATIONS
CLAIRITY BREAST should not be used for patients with known inherited gene mutations related to breast cancer, such as BRCA1/BRCA2.
WARNINGS
Warning: CLAIRITY BREAST is intended to augment current clinical workflow only in the domain of future risk assessment. CLAIRITY BREAST is not intended to influence the interpretation of a screening mammogram in terms of detecting or diagnosing disease.
Warning: The determination of the need for diagnostic workup or other follow-up of abnormal screening findings should be based on the mammography imaging findings, not the CLAIRITY BREAST output.
Warning: CLAIRITY BREAST is not intended to replace a healthcare provider’s review of a mammogram or the healthcare provider’s assessment of the patient’s future risk of breast cancer. Referral, management, and treatment decisions require correlation with patient history and other clinical information. Decisions should not be made based solely on analysis by CLAIRITY BREAST.
Warning: As with any risk prediction, there is a risk of falsely overestimated risk which could potentially lead to additional unnecessary medical procedures and a risk of falsely underestimated risk which could potentially contribute to delay of further evaluation or treatment. Please refer to Clinical Data & Performance results to better understand the accuracy of CLAIRITY BREAST’s predictions.
Warning: All patients carry some risk of developing breast cancer in the future, even patients with very low CLAIRITY BREAST predictions.
Warning: CLAIRITY BREAST is not intended to diagnose, detect, or inform the treatment of disease.
PRECAUTIONS:
Caution: The effectiveness of CLAIRITY BREAST has not been demonstrated for the subpopulation of patients with breast implants.
Caution: CLAIRITY BREAST scores greater than 5% should be interpreted with caution. While all scores greater than 5% are considered high risk, high risk scores produced by the model may tend to significantly overestimate risk, particularly scores above 10%.
Caution: The device prediction of 5-year cumulative risk of breast cancer is unadjusted for competing risks of mortality. CLAIRITY BREAST’s risk estimation is based on screening mammograms only and thus requires a screening mammogram to generate a risk prediction. As such, it cannot be used to determine when screening mammography should be initiated for a specific patient.
CLAIRITY BREAST COMPATIBILITY
CLAIRITY BREAST has been validated for images from the Hologic Lorad Selenia and Selenia Dimensions systems.
CLAIRITY BREAST can analyze only directly acquired 2-dimensional images acquired from compatible full field digital mammography systems and digital breast tomosynthesis systems. It is not compatible with synthetic 2D (s-2D) and digital breast tomosynthesis (DBT) images.
ACCEPTABLE IMAGES
This device requires clinically acceptable images to perform as intended. Clinically flawed images, such as those with grid placement errors that intersect or are adjacent to breast tissue, should not be included in exams sent for CLAIRITY BREAST predictions. These types of images could cause inaccurate risk predictions.
ERROR MESSAGING
CLAIRITY BREAST will not generate results for exams that do not meet specific criteria and will instead provide detailed error messages as described in Operating Instructions.
ADDITIONAL INFORMATION
Healthcare providers should refer to the full User Manual for full product labelingand additional important information about using CLAIRITY BREAST and interpreting results. Patients should reach out to their Healthcare Providers with any questions on whether Clairity Breast is right for them.
