Aware TM Pad is a thin polyurethane bladder, 9.5 inches in diameter containing a small quantity of silicone fluid. The very thin nature of the polyester polyurethane allows the pad 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 bladder, provides easy sliding between the upper and lower surfaces of the bladder. Therefore, when properly used between the finger and the soft breast tissues of the patient, a reduction of friction is observed.

AI/ML Overview

The provided text is a 510(k) summary for the Aware™ Pad, a device indicated as an aid for performing breast self-examination. This document is a regulatory submission for market clearance and does not contain a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.

Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, the Sensor Pad® (K973450). This process does not typically involve the detailed performance studies or pre-defined acceptance criteria that would be seen for higher-risk devices or novel technologies.

Therefore, many of the requested information points (acceptance criteria, specific study details, ground truth, expert qualifications, sample sizes for test/training, MRMC studies, standalone performance) are not applicable or not provided within the scope of this 510(k) summary.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) submission for the Aware™ Pad does not define explicit performance acceptance criteria and does not report detailed performance metrics from a study in the same way a diagnostic device would. The primary "performance" assessed is its technological characteristics demonstrating substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Not defined in the document. The regulatory pathway is based on "substantial equivalence" to a predicate device, not on meeting specific quantitative performance metrics.	The device is described as a thin polyurethane bladder containing silicone fluid. Its technological characteristics aim to reduce friction during breast self-examination, facilitating easy sliding between the finger and breast tissues. This is compared to the predicate device, the Sensor Pad®.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable/Not Provided. A "test set" in the context of device performance testing for the Aware™ Pad is not described in this 510(k) summary. The submission relies on establishing substantial equivalence based on technological characteristics and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable/Not Provided. The concept of "ground truth" established by experts for a test set is not presented for this device given the nature of the 510(k) submission and the device's function.

4. Adjudication Method for the Test Set

Not Applicable/Not Provided. As there is no described test set or expert evaluation detailed, an adjudication method is not relevant or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for the Aware™ Pad in this 510(k) summary. This type of study is typically used for imaging or diagnostic devices to assess reader performance. The Aware™ Pad is a simple aid for self-examination, not a diagnostic tool requiring such rigorous clinical validation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. The Aware™ Pad is a physical device (a pad to aid tactile examination), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

Not Applicable/Not Provided. For this device, ground truth in the sense of a clinical outcome or diagnostic truth is not defined. The basis for market clearance is "substantial equivalence" to an existing device, implying that the predicate's effectiveness is already established for its intended use as an aid for breast self-examination.

8. The Sample Size for the Training Set

Not Applicable/Not Provided. The Aware™ Pad is a physical device and does not involve AI/machine learning, and therefore does not have a "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set was Established

Not Applicable/Not Provided. As there is no training set, this question is not applicable.

Summary

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510(k) SUMMARY

This Summary was prepared in accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

GENERAL INFORMATION:
Establishment -	AAC Consulting Group, Inc.
	7475 Wisconsin Ave., Suite 850
	Bethesda, MD 20814
Contact Person:	Eduardo March, Senior Consultant
	Teleph.- 301-986-4440	Fax- 301-986-4448
Device Name -	Aware ™ Pad
Classification Name-	Mammographic X-ray Systems (CFR 892.1710), Class II

============================================================================================================================================================================== PERFORMANCE STANDARD: No mandatory performance or voluntary standards are applicable.
||| SUBSTANTIAL EQUIVALENCE: The Aware TM pad is substantially equivalent to a currently marketed device, the Sensor Pad® (K973450).

111 INDICATIONS FOR USE: The Aware™ Pad is indicated as an aid for performing breast self-examination.

TECHNOLOGICAL CHARACTERISTICS: IV

Prepared: 19 April 1999

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Image /page/1/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, one behind the other, with a stylized design below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Mr. Eduardo March, RAC Senior Consultant AAC Consulting Group, Inc. 7575 Wisconsin Avenue, Suite 850 Bethesda, MD 20814

Re: K991469 Aware™ Pad Dated: April 26, 1999 Received: April 28, 1999 Regulatory Class: II 21 CFR §892.1560/Procode: 90 IYO

Dear Mr. March:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, blease note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known): K 991469

Aware™ Pad Device Name:

Indications for Use:

The Aware™ Pad is indicated as an aid for performing breast selfexamination.

vision Sign-Off)
vision of Reproductive, Abdominal, ENT,
nd Radiological Devices
510(k) Number K991469

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Prescription Use: (Per 21 CFR 80.109)

Over-the-Counter Use:

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.