The DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

Device Description

The Restore Orthibiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a bionaterial desived from porcine small intestine. SIS is composed presionshately of water and collagen. This material to the material approved in IDF. G960196 for investigational use as an Anterior Cruciate Ligament (ACL) replacement device and submitted in K974540 for Hernia Repair. The device is intended to act as a resorbable scaffold which initially has sufficient mechanical strength to assist with a soft tissue repair, but then resorbs and is replaced by the patients own tissue.

AI/ML Overview

The provided text is a 510(k) submission summary for the DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information, which is relevant to AI/ML device testing, is not applicable to this document.

However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the context of specific quantitative acceptance criteria and device performance metrics, as is common for AI/ML device evaluations. The document focuses on showing "comparable" mechanical properties to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Comparable suture retention strength	Restore Orthobiologic Soft Tissue Implant and BioVascular Supple Periguard have comparable suture retention strength.
Comparable mechanical strength (ball burst tests)	Restore Orthobiologic Soft Tissue Implant and BioVascular Supple Periguard have comparable mechanical strength as measured by ball burst tests.
Biocompatibility (ISO 10993 and other standards)	Biocompatibility tests, performed according to ISO 10993, other accepted standards and other appropriate test methods indicate that the SIS material is biocompatible.
Efficacy for soft tissue repair/replacement (animal studies)	Numerous animal efficacy studies indicate that SIS, in various configurations, is efficacious when used for soft tissue repair or soft tissue replacement.
Absence of rejection	In all animal studies, the SIS implant served as a scaffold for new tissue formation and no evidence of rejection of the material was observed.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document refers to "numerous animal efficacy studies" but does not specify a sample size for an overall "test set."
- Data Provenance: The studies are described as "animal efficacy studies." No country of origin is specified. The nature of these studies (e.g., retrospective or prospective) is not detailed.
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)
Not applicable. The ground truth for this type of device (surgical mesh) is typically established through histopathological analysis in animal studies and clinical outcomes, not expert consensus reading of images or diagnoses. No information on experts establishing ground truth is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for human-read interpretations (e.g., medical image analysis) where multiple experts assess cases. This document describes material and animal studies.
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. This is not an AI/ML device and therefore, no MRMC study or AI assistance evaluation was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Based on the description of "animal efficacy studies," the ground truth would inherently involve:
- Pathology/Histology: Assessing new tissue formation, scaffold resorption, inflammation, and integration in animal models.
- Outcomes Data (Animal Models): Functional outcomes related to the repair (e.g., strength of repair, recurrence of defect).
The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the sense of machine learning. The "numerous animal efficacy studies" that establish efficacy of SIS material generally pre-date this 510(k) submission, serving as foundational evidence for the material's properties and performance.
How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned in the context of AI/ML. The evidence used to support the device's efficacy and substantial equivalence comes from scientific studies and established material characteristics of SIS.

Summary

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SEP 2 5 1998

CLINREGLGL

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF SPONSOR:	DePuy, Inc. P.O. Box 988 Warsaw, Indiana 46581-0988
510(k) CONTACT:	Cheryl Hastings Manager, Regulatory Submissions
TRADE NAME:	DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant
COMMON NAME:	Surgical Mesh
CLASSIFICATION:	878.3300 - Surgical Mesh
DEVICE PRODUCT CODE:	79 FTM
SUBSTANTIALLY EQUIVALENT DEVICES:

· Organogenesis Graft Patch (K970561)
· Sentron SIS Hernia Repair Device (K974540)
· Bio-Vascular Supple Peri-guard (K923657)
· Cook Biotech Inc. SIS Wound Dressing (K973170)
· Cook Biotech Inc. SIS Surgical Mesh (K980431)

DEVICE DESCRIPTION AND INTENDED USE:

The Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a resorbable scaffold which initially has sufficient mechanical strength to assist with a soft tissue repair, but then resorbs and is replaced by the patients own tissue.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Orth Tech Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices in that it is manufactured from the same matcrial (SIS. porcine small intessine submucosa) as the Sentron SIS Hernia Repair Device and the Cook Biotech Inc. SIS Wound Dressing and SIS Surgical Mesh. The material is very similar to that of the Organogenesis Graft Patch (described as cross-linked porcine collagen). It has the same intended use (reinforcing soft tissue) as the Organogenesis Graft Patch, the Bio-Vascular Supple Peri-guard, and the SIS Surgical Mesh and it has : similar design to all five of these soft tissue patches. Mechanical testing shows that the Restore Orthobiologic Soft Tissue Implant and the BioVascular Supple Periguard have comparable suture retention strength and mechanical strength as measured by ball butst tests. Biocompatibility tests, performed according to ISO 10993, other accepted standards and other appropriate test methods indicate that the SIS material is biocompatible. Numerous animal efficacy studies indicate that SIS, in various configurations is efficacious when used for soft tissue repair or soft tise ue replacement. These studies include: repair of abdominal aponeuroses and the

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abdominal wall, fascial and capsular defects, and patellar and achilles tendons, and replacement of infraspinatus tendras and cranial cruciate ligaments. In all of these studies the SIS implant served as a scaffold for hew tissue formation and no evidence of rejection of the material was observed.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 1998

Ms. Cheryl K. Hastings Manager, Requlatory Submission Depuy, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K982330 Trade Name: DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant Requlatory Class: II Product Code: FTM June 30, 1998 Dated: Received: July 02, 1998

Dear Ms. Hastings:

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 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 qeneral controls provisions The general controls provisions of the Act 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 requirement, 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 requlatory 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 - Ms. Cheryl K. Hastings

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) 594-4595. 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/dsmamain.html".

Sincerely yours,

Col. Mr. Histo. Bio. Res. M.

a 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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510(k) Number (if known)

Device Name DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant

Indications for Use:

The DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

Concurrence of CDRH, Office of Device Evaluation

ision Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices K982330
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

. . .

000002

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.