Tornier® BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Tornier® BioFiber Scaffold is intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.

Tornier® BioFiber Scaffold is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Device Description

Tornier® BioFiber Scaffold is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into anv desired shape or size without unraveling. The device is supplied sterile, for sinqle-patient use for the reinforcement of soft tissue where weakness exists.

AI/ML Overview

This 510(k) summary (K102788) for the Tornier® BioFiber Scaffold does not contain the information needed to answer your questions thoroughly.

The document is a premarket notification for a medical device (surgical mesh) claiming substantial equivalence to previously cleared devices. It focuses on the device's description, intended use, and substantial equivalence to predicates, but does not provide details on specific acceptance criteria, pre-clinical or clinical studies with performance data, or ground truth establishment relevant to the performance of a device like an AI algorithm.

Here's a breakdown of what the document does and does not provide:

What the Document Provides:

Device Name: Tornier® BioFiber Scaffold
Classification: Class II, Absorbable Surgical Mesh, Product Code FTL
Intended Use/Indications: Reinforcement of soft tissues where weakness exists, repair of fascial defects, and reinforcement of rotator cuff, patellar, Achilles, biceps, and quadriceps tendons during tendon repair surgery. It explicitly states it's not for replacement of normal body structures or to provide full mechanical strength.
Predicate Devices: TephaFLEX™ Surgical Mesh (K070894) and Tornier® Surgical Mesh (K093799).
Substantial Equivalence Claim: The device is claimed to be "exactly the same device as the Tornier predicate device" and that "scientific evidence of substantial equivalence has been previously submitted to FDA."

What the Document Lacks (and is necessary to answer your questions):

The 510(k) summary is for a physical medical device (surgical mesh), not an AI/algorithm-based device. Therefore, it does not typically involve the types of studies, metrics, or ground truth establishment that would be present for an AI-powered diagnostic or predictive tool.

Specifically, the document does not contain any of the following information requested:

A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or quantitative acceptance criteria, as it's not an AI diagnostic.
Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic "test set" in the context of this physical mesh.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improvement with AI vs without AI assistance: Not applicable, as this is not an AI diagnostic device for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) document is for a physical surgical mesh and is aimed at demonstrating substantial equivalence to predicates, not at proving the performance of an AI algorithm or diagnostic tool against specific acceptance criteria. Therefore, the requested information regarding AI device performance studies and ground truth establishment is not present in this document.

Summary

{0}------------------------------------------------

K102788

1 of 2

510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

MAY 1 0 2011

Tornier, Inc. Name:

Lael J. Pickett Contact: Director Regulatory and Clinical Affairs Tornier, Inc.

Office: 952-426-7641 Cell: 612-219-7350 Fax: 952-426-7601 Email: Ipickett@tornier.com

Date Prepared April 15, 2010

General Device Information

Product Name: Tornier® BioFiber Scaffold
"Absorbable Surgical Mesh" Classification: Product code: FTL - Class II

Predicate Device

Tepha, Inc.	TephaFLEX™ Surgical Mesh
	[510(k) Number K070894]

Tornier, Inc.	Tornier ® Surgical Mesh
	[510(k) Number K093799]

{1}------------------------------------------------

Description

Intended Use (Indications)

Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Substantial Equivalence

This submission supports the position that the Tornier™ BioFiber Scaffold is substantially equivalent to previously cleared devices, including those listed above. A number of predicate devices list the same range of clinical uses. Scientific evidence of substantial equivalence has been previously submitted to FDA. The device that is the subject of this submission is exactly the same device as the Tornier predicate device.

Conclusions

Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier® Surgical Mesh. The materials from which the Tornier device is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an emblem that resembles a stylized eagle or bird-like figure, composed of three curved lines that suggest wings and a body. The emblem is black, and the background is white.

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

Tornier, Inc. % Mr. Howard L. Schraver 100 Cummings Center - Suite 444C Beverly, Massachusetts 015

MAY 1 0 2011

Re: K102788

Trade/Device Name: Tornier® BioFiber Scaffold Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 15, 2011 Received: April 18, 2011

Dear Mr. Schrayer:

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

{3}------------------------------------------------

Page 2 - Mr. Howard L. Schrayer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding 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/McdicalDevices/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 Division 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Tornier® BioFiber Scaffold

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krumlauf MXM

(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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.