Collagen Tendon Sheet is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.

AI/ML Overview

This K112423 510(k) summary describes the Collagen Tendon Sheet device and its substantial equivalence determination to a predicate device. This submission relies heavily on a comparison to the predicate, rather than an independent de novo study with acceptance criteria. Therefore, the requested information elements related to standalone performance, MRMC studies, sample sizes, and ground truth establishment for a new device's performance study are not directly available from this document.

However, I can extract and infer information relevant to the substantial equivalence determination for this device, presented to the best of what the document provides:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance study. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The "performance" is therefore measured against how closely the new device matches the predicate's characteristics and safety profile.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as demonstrated for Collagen Tendon Sheet)	Notes
Intended Use Equivalence: Same intended use as the predicate device.	"Collagen Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue." (Matches predicate's use)	Stated explicitly.
Technological Characteristics Equivalence: Same design, material characterization, chemical composition, purity, density, and strength as predicate.	"Collagen Tendon Sheet and its predicate device have the same technological characteristics. In particular, Collagen Tendon Sheet and its predicate are the same with respect to intended use, design, material characterization." "Collagen Tendon Sheet and its predicate have been characterized for chemical composition, purity, density, and strength to demonstrate substantial equivalence."	Demonstrated through in vitro characterization studies. Minor differences in size, thickness, and form (flat sheet) acknowledged but deemed not to affect equivalence.
Manufacturing Equivalence: Similar processing, same facilities, same manufacturer, same raw materials as predicate.	"The Collagen Tendon Sheet and its predicate device are manufactured with similar processing, in the same facilities, by the same manufacturer, using the same raw materials."	Stated explicitly.
Biocompatibility: Meet established standards for biological evaluation of medical devices.	"The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices."	Demonstrated through in vitro and in vivo biocompatibility studies.
Safety (Viral Inactivation): Ensure viral safety of the product.	"Viral inactivation studies were performed to ensure the viral safety of the product."	Demonstrated through viral inactivation studies.
Efficacy (Animal Study): Demonstrate efficacy comparable to the predicate device in an animal model.	"An animal efficacy study was conducted to evaluate the device as compared to its predicate device." (No specific results provided, but the conclusion states "animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device.")	Study performed, findings used to support substantial equivalence.

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

Test Set Sample Size: Not explicitly stated for specific studies (e.g., in vitro, biocompatibility, animal efficacy). The conclusion states "The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, as well as the animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device." This implies these studies formed the basis for the "test" of substantial equivalence.
Data Provenance: Not specified, but given the company address (Plymouth, MN) and FDA submission, it is likely mostly US-based data, though not explicitly stated. The studies are described as pre-market (non-clinical).

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

Not applicable in the context of this 510(k) submission, as it relies on pre-clinical studies (in vitro, animal) and comparison to a predicate, not on a human-read diagnostic test requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic device requiring human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh/tendon sheet, not an AI-assisted diagnostic or imaging device.

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

"Standalone" in the context of an algorithm or AI is not applicable here. The device itself is a physical implant. The listed studies (in vitro, biocompatibility, animal efficacy) represent the "standalone" performance evaluation of the device's material and biological properties.

7. The Type of Ground Truth Used

For in vitro characterization: Laboratory measurements and established material science standards.
For biocompatibility: Standards like FDA G95-1 and ISO 10993-1, with endpoints like cytotoxicity, irritation, sensitization, systemic toxicity, etc. (often evaluated by trained toxicologists/pathologists as per standard protocols).
For animal efficacy study: Animal model outcomes (e.g., tendon healing, tissue response) compared against the predicate device. These would be assessed by veterinary researchers and often histopathologists.
For viral inactivation: Established viral testing protocols and assays.

8. The Sample Size for the Training Set

Not applicable. This device does not use an algorithm that requires a training set. The data used for demonstrating its properties and equivalence would be considered "test" data in a general sense, not "training" data for an AI model.

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

Not applicable, as there is no training set for an algorithm.

Summary

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K112423 > | of 2

Image /page/0/Picture/1 description: The image shows the logo for Rotation Medical. The logo consists of a circular arrangement of dots above the word "rotation" in a stylized font. Below "rotation" is the word "MEDICAL" in a smaller, sans-serif font.

DEC 2 2 2011

510(k) Summary

Applicant Information

Applicant Name: Applicant Address:

Telephone: Fax: Contact Person:

Rotation Medical, Inc. 15350 25th Avenue North, Suite 100 Plymouth, MN 55447 763-746-7502 763-746-7501 Jeff Sims Vice President, Clinical Programs and Regulatory Affairs August 22, 2011/November 14, 2011/December 13, 2011

Date Prepared/Revised:

Name of Device

Device Common Name: Device Trade Name: Device Classification Name:

Tendon Protector Collagen Tendon Sheet Mesh, Surgical 878.3300 Class II FTM

Legally Marketed Devices to Which Substantial Equivalence is Claimed

Predicate Device(s):

Collagen Tendon Wrap. K0080452 Collagen Matrix, Inc., Oakland, NJ

Description of the Device

Intended Use

Collagen Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

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Summary/Comparison of Technical Characteristics

Collagen Tendon Sheet and its predicate device have the same technological characteristics. In particular, Collagen Tendon Sheet and its predicate are the same with respect to intended use, design, material characterization. The substantial equivalence of the Collagen Tendon Sheet and its predicate was demonstrated primarily based on in vitro characterization studies, biocompatibility studies, an animal efficacy study, and clinical experience of the predicate device. In vitro characterization studies included evaluation of material properties, biological properties, chemical and physical properties.

The Collagen Tendon Sheet and its predicate device are manufactured with similar processing, in the same facilities, by the same manufacturer, using the same raw materials. They vary with respect to size and thickness. In addition, the Collagen Tendon sheet is provided in a flat form.

Collagen Tendon Sheet and its predicate have been characterized for chemical composition, purity, density, and strength to demonstrate substantial equivalence. Testing was conducted in accordance to FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.

Collagen Tendon Sheets have been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

An animal efficacy study was conducted to evaluate the device as compared to its predicate device. No clinical tests were performed on the product; however clinical history of the predicate device was referenced in the submission.

Viral inactivation studies were performed to ensure the viral safety of the product.

Conclusion of Non-clinical Studies

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, as well as the animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device.

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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 stylized eagle with three stripes representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

Rotation Medical, Incorporated % Mr. Jeff Sims Vice President, Clinical Programs and Regulatory Affairs 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447

Re: K112423

Trade/Device Name: Collagen Tendon Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 16, 2011 Received: December 16, 2011

Dear Mr. Sim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Jeff Sims

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Clice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice related duverse oversion (21 CFR Part 820); and if applicable, the electronic forth in the quand on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you dosire specific ad 100 500 your PDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misoranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vor

For

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential Rotation Medical, Inc.

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __Collagen Tendon Sheet

Indications for Use:

Collagen Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Prescription Use _ X (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)

Daniel Keane for MKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112423

Page 1 of _1

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.