The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.

Device Description

The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Shelhigh No-React® EnCuff Patch, which is a surgical mesh. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria and performance studies in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain details of specific acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance metrics (e.g., sensitivity, specificity, accuracy for an AI device). Instead, it focuses on demonstrating technological characteristics and intended use are substantially equivalent to a legally marketed predicate device.

However, based on the information provided, we can infer some "acceptance criteria" in the context of a 510(k) and outline the "study" (bench testing and comparison) used to support equivalence.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferrred from 510(k) Submission)	Reported Device Performance (from text)
Intended Use Equivalence	"The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery." This is identical to the predicate device's intended use.
Technological Characteristics Equivalence	- "The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process." - "The device is provided sterile in 2% benzyl alcohol solution." - "Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc."
Material Properties (Bench Testing)	- "Shelhigh EnCuff material exhibits good tensile strength," - "shrink temperature," - "and suture retention." - "The material reapproximates well around suture holes." - "It is soft and pliable."
Biocompatibility	"The material exhibits excellent biocompatibility, and passed the requirements of all tests."
Substantial Equivalence Conclusion	"This device is, in respect to intended use and technological characteristics, substantially equivalent to the predicate devices."

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

Sample Size: Not applicable in the context of clinical test sets for performance metrics. The submission refers to material testing, where "sample size" would relate to the number of material specimens tested for physical properties. This specific number is not provided.
Data Provenance: Not applicable in the context of clinical test sets. The material testing would be conducted in a laboratory setting by the manufacturer, Shelhigh Inc.

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

Not applicable. This is a 510(k) submission for substantial equivalence based on material properties and intended use, not a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable.

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

No, a MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a surgical mesh 510(k) submission.

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

Not applicable. This device is a surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

For the material properties, the "ground truth" would be established by standardized laboratory testing methods against pre-defined specifications (though the exact specifications are not detailed in this summary). For biocompatibility, it refers to "passed the requirements of all tests," indicating compliance with established biocompatibility standards.
For the overall determination of substantial equivalence, the "ground truth" is a comparison to the characteristics and intended use of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of device submission.

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

Not applicable.

Summary

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DEC 1 9 2003

KO32893

Page 1 of 1

December 5, 2003

Summary of safety and efficacy Shelhigh EnCuff Patch

Applicant: Shelhigh Inc. 650 Liberty Ave, Union, NJ 07083

Contact person: Shlomo Gabbay, MD Tel: 908-206-8906 Fax 908-206-8725

l. Proprietary and Common Name:

Shelhigh No-React® EnCuff Patch Trade name: Common name : Surgical Mesh Classification: 878.3300 - Surgical Mesh Product Code: 79 FTM

ll. Predicate Devices:

The Shelhigh EnCuff Patch is Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc.

Intended Use

The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery.

IV. Product Description

The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.

VI. Substantial Equivalence

It is substantially equivalent to the predicate devices, having the same intended use and technological characteristics.

VII Shelhigh EnCuff material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable. The material exhibits excellent biocompatibility, and passed the requirements of all tests
Conclusions: This device is, in respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three overlapping shapes that resemble birds in flight, rendered in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Shlomo Gabbay, M.D. Medical Director Shelhigh, Inc. 650 Liberty Avenue Union, New Jersey 07083

Re: K032893

Trade/Device Name: Shelhigh No-React ® EnCuff Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: September 16, 2003 Received: September 30, 2003

Dear Dr. Gabbay:

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 may 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 - Shlomo Gabbay, M.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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam 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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Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

KO32823

Meriam C. Provost

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

510(k) Number .

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.