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The SensaTouch™ - Breast Self-Exam Glove is indicated as an aid for performing breast selfexaminations.

SensaTouch™ is indicated as an aid for performing breast self-examinations.

The SensaTouch™ - Breast Self-Exam Glove is a very thin double wall polyurethane glove, 8 inches in diameter containing a small quantity of colored lubricating fluid. The very thin nature of the polyester polyurethane allows the glove to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible glove, provides easy sliding between the upper and lower surfaces of the glove. Therefore, when properly used between the fingers and the soft breast tissues of the patient, a reduction of friction is observed.

The provided text is a 510(k) summary for the SensaTouch™ Breast Self-Exam Glove. It is a Class II device intended as an aid for performing breast self-examinations. The submission states that the device is substantially equivalent to other marketed OTC devices.

However, the document is a premarket notification for a physical device (a glove for breast self-examination), not an AI/ML powered device. As such, it does not contain information typically associated with the evaluation of AI/ML devices, such as performance criteria based on metrics like sensitivity, specificity, or accuracy, nor does it include studies involving test sets, ground truth establishment, or expert adjudications.

Therefore, I cannot provide a detailed answer to your request, as the information regarding acceptance criteria and performance studies for AI/ML devices is not applicable or present in the given text.

The document focuses on:

• Device Description: A thin double-wall polyurethane glove with lubricating fluid.
• Intended Use: Aid for breast self-examinations.
• Substantial Equivalence: To existing OTC devices like Sensor Pad, My Breast Friend, and Aware Pad.
• Regulatory Classification: Class II, 21 CFR 892.1710 "Mammographic x-ray System (accessory)" (though the FDA letter later corrects this to 21 CFR 892.1560 "Ultrasonic pulsed echo imaging system" and product code 90 IYO).

There is no data within this document about:

1. Acceptance criteria and reported device performance (in the context of AI/ML metrics).
2. Sample size, data provenance for a test set.
3. Number of experts, qualifications, or adjudication methods for ground truth.
4. MRMC comparative effectiveness studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth (expert consensus, pathology, outcomes data).
7. Sample size for a training set.
8. How ground truth for a training set was established.

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