The provided text is a 510(k) summary for the MammoPad Radiolucent Cushion, which is a medical device intended to provide comfort and aid in positioning during breast imaging. This document describes the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/algorithm-based device.

The MammoPad is a physical accessory (a foam cushion) rather than an AI or algorithm. Therefore, the questions related to AI/algorithm performance (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable to this device submission.

The "Technological Characteristics/Performance Data Summary" section (excerpt {1}) explicitly states that "MammoPad is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics." The conclusion is that it is "substantially equivalent to an existing legally marketed device." This highlights that the approval pathway for this device was based on substantial equivalence, not on meeting specific performance metrics derived from a clinical study for a diagnostic algorithm.

Therefore, I cannot provide the requested table and study details because the provided document does not contain that type of information for this specific device.

For clarity, here's what the document does indicate about the device and its regulatory pathway:

Device Name: MammoPad Radiolucent Cushion
Intended Use: "Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology."
Device Type: A physical, non-sterile, single-use foam cushion.
Regulatory Pathway: 510(k) Pre-market Notification, approved based on substantial equivalence to predicate devices (MammoPad® (K003795), Scintimammography Pad Set, PineStar Technology, Scintimammography Pad, Cone Instruments).
Performance Data: The submission relies on demonstrating that the device has "the same principles of operation and overall technological characteristics" as the predicate devices. There is no mention of a formal clinical performance study with defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., as would be expected for an AI diagnostic device.

Summary

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SEP 1 3 2006

4. 510(k) Summary of Safety and Effectiveness	K06 2141
Device Name:	MammoPad Radiolucent Cushion
Classification Name:	Accessory to X-Ray Mammographic System (IZH21 CFR, 892.1710Accessory to Scintillation (Gamma) Camera (IYX21 CFR, 892.1100
Device Classification:	Class II (IZH)Class I (IYX)
Predicate devices:	MammoPad® (K003795)Scintimammography Pad Set, PineStar TechnologyScintimammography Pad, Cone Instruments
Manufacturer:	BioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656
Establishment RegistrationNumber:	2032338
Official Contact:	Sheryl HigginsBioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656Phone: (949) 349-1380 (x101)

Intended Use:

MammoPad is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.

Device Description:

MammoPad is a radiolucent foam cushion used during radiologic visualization of the breast. MammoPad is non-sterile and is a single use device.

{1}------------------------------------------------

Technological Characteristics/Performance Data Summary

MammoPad is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.

Conclusion:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, MammoPad is determined to be substantially equivalent to an existing legally marketed device

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is black. The text is likely part of a document or presentation.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 3 2006

Ms. Sheryl W. Higgins Director of Engineering BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656

Re: K062141

Trade/Device Name: MammoPad Radiolucent Cushion Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IYX and IZH Dated: July 26, 2006 Received: July 27, 2006.

Dear Ms. Higgins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 II (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in the center. Above the letters are the numbers "1906-2006". Below the letters is the word "Centennial". There are three stars below the word "Centennial".

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 06 乙乙乙乙乙乙乙乙乙 (

Device Name:

MammoPad Radiolucent Cushion

Indications for Use:

Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number R062141

Confidential

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).