SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL by TISSUE TECHNOLOGIES, INC.

{
"1. A table of acceptance criteria and the reported device performance": "The provided text is an FDA 510(k) clearance letter and an 'Indications for Use' page. It does not contain information about specific acceptance criteria or detailed device performance metrics. Its purpose is to declare substantial equivalence to a predicate device and outline the approved indications for use.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided document does not contain information about a test set sample size or data provenance. This type of detail is typically found in the 510(k) submission itself, not in the clearance letter or indications for use.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "The provided document does not contain information about experts used to establish ground truth or their qualifications. This is not typically part of an FDA clearance letter.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "The provided document does not contain information about an adjudication method for a test set. This detail would be found in the device's validation study, not in the regulatory clearance.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "The provided document does not contain information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human-AI collaboration. This type of study is more common for diagnostic AI tools, which doesn't seem to be the primary function of the 'Softform® Implant' mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The provided document does not contain information about a standalone algorithm performance study. The device, 'Softform® Implant', is described as a 'Soft Tissue Augmentation Tube with Insertion Tool', suggesting it's a physical implant and not an algorithm-based device requiring standalone performance evaluation.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The provided document does not contain information about the type of ground truth used. As a medical implant, 'ground truth' for its safety and effectiveness would likely come from pre-clinical testing, clinical trials, and material properties, rather than expert consensus on image interpretation or pathology in the context of an algorithm.",
"8. The sample size for the training set": "The provided document does not contain information about a training set sample size. Given the nature of the device ('Softform® Implant' - a soft tissue augmentation tube), it is highly unlikely that an AI training set would be relevant or discussed in its regulatory clearance.",
"9. How the ground truth for the training set was established": "The provided document does not contain information about how ground truth for a training set was established. As noted above, this device does not appear to be an AI/algorithm-based device for which a training set and its associated ground truth would be relevant."
}

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Jesse Kramer, Ph.D Tissue Technologies, Inc. 1370 Green Street San Francisco, California 94109

Re: K982475 Trade Name: Softform® Implant Regulatory Class: II Product Code: FTL Dated: July 14, 1998 Received: July 16, 1998

Dear Dr. Kramer:

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 (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 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 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.

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Page 2 - Jesse Kramer, Ph.D

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 yilry diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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,

f. Joseph

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TISSUE TECHNOLOGIES, INC.

1370 Green Street SAN FRANCISCO, CA 94109

PHONE 415/885-6269 FAX 415/885-6380

Image /page/2/Picture/4 description: The image shows the text "K982475" in a handwritten style at the top. Below this, the words "INDICATIONS FOR USE PAGE" are printed in a bold, sans-serif font. The text appears to be part of a document or label, possibly related to instructions or guidelines for using a product.

September 15, 1998

PRODUCT: Softform® Implant
REFERENCE: 510(k)#: K982475 Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications

INDICATIONS: For Plastic and Reconstructive Surgery*

This product is available by prescription only.

Prescription Use
(Per 21 CFR 801.109)

fo colly

eral Re

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.