The DePuy Restore® Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues, which are repaired by suture or suture anchors, during rotator cuff repair surgery.

The Restore® Implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore® Implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Device Description

AI/ML Overview

The document provided is a 510(k) summary for the DePuy Restore® Orthobiologic Soft Tissue Implant, indicating an expanded intended use for rotator cuff repair. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and performance study results as would be found in a clinical trial report for novel technologies.

Therefore, many of the requested details regarding acceptance criteria, study design elements such as sample sizes, expert qualifications, adjudication methods, ground truth establishment, and specific performance metrics for the device are not available in this summary. The 510(k) process is primarily a comparison to existing devices.

However, I can extract the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance
Material Composition	Manufactured from 10 plys of Small Intestine Submucosa (SIS), derived from porcine small intestine, composed predominately of water and collagen. Identical to predicate devices (K982330, K001738).
Device Design	Round device. Same device design as predicate devices.
General and Specific Use	Same general and specific use as predicate devices.
Expanded Indication	Expanded intended use for reinforcement of soft tissues, repaired by suture or suture anchors, during rotator cuff repair surgery. This expanded indication "does not alter the therapeutic effect based upon safety and effectiveness considerations and evidenced by clinical data."
Functional Role	Reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. Not intended to replace normal body structure or provide full mechanical strength. Sutures and anchors provide mechanical strength for rotator cuff repair.
Substantial Equivalence	Determined to be substantially equivalent to Restore® Orthobiologic Soft Tissue Implants (K982330 and K001738).

2. Sample size used for the test set and the data provenance:

Not specified in this 510(k) summary. The document states that the expanded indication is "evidenced by clinical data," but does not provide details on the study design, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in this 510(k) summary.

4. Adjudication method for the test set:

Not specified in this 510(k) summary.

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:

Not applicable/Not mentioned. This device is a surgical mesh, not an AI-assisted diagnostic tool.

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

Not applicable/Not mentioned. This is a medical device (surgical mesh), not an algorithm.

7. The type of ground truth used:

The basis for substantial equivalence for the expanded indication is stated as "safety and effectiveness considerations and evidenced by clinical data." However, the nature of this clinical data (e.g., specific outcome measures, pathological findings, etc.) is not detailed in this summary. For a mesh, ground truth for effectiveness would likely relate to successful tissue reinforcement, integration, and lack of adverse events, typically demonstrated through clinical outcomes.

8. The sample size for the training set:

Not applicable/Not specified. This is a manufactured medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable/Not specified. This is a manufactured medical device.

Summary

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JUL 2 8 2003

20319698,12

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF SPONSOR:

DePuy, Inc. P.O. Box 988 Warsaw, Indiana 46581-0988

510(k) CONTACT:

Kathy K. Trier, Ph.D. Senior Regulatory Associate

TRADE NAME:

COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE: Surgical Mesh 878.3300 - Surgical Mesh 79 FTM

SUBSTANTIALLY EQUIVALENT DEVICES:

◆ Restore® Orthobiologic Soft Tissue Implant (K982330)
DePuy Restore® Orthobiologic Soft Tissue Implant
� Restore® Orthobiologic Soft Tissue Implant (K001738)

DEVICE DESCRIPTION AND INTENDED USE:

The Restore® Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material and device configuration approved in K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists and K001738 for reinforcement of the soft tissues, which are repaired by suture or suture anchors during rotator cuff repair, limited to the supraspinatus.

This submission is for the following expanded intended use:

The DePuy Restore® Orthobiologic Soft Tissue Implant is intended for use for reinforcement of the soft tissues, which are repaired by suture or suture anchors, during rotator cuff repair surgery.

The Restore® implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore® implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Restore® Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed device (K982330, K001738) in that it is manufactured from the same material (SIS, porcine small intestine submucosa), has the same device design, has the same general and specific use as the predicate device, and has the additional expanded indication for use

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03/1969 P2/2

that does not alter the therapeutic effect based upon safety and effectiveness considerations and evidenced by clinical data.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2003

Dr. Kathy K. Trier, Ph.D. Senior Regulatory Affairs Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K031969

Trade/Device Name: Restore® Orthobiologic Soft Tissue Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: June 24, 2003 Received: June 26, 2003

Dear Dr. Trier:

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 (PMA), 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 mav publish further announcements concerning your device in the Federal Register.'

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.

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Page 2 - Dr. Kathv K. Trier, Ph.D.

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 (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Miriane C. Provost

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

Enclosure

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K03/969

510(k) Number (if known)

Device Name: Restore® Orthobiologic Soft Tissue Implant

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031969

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use

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.