Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Device Description

The Tornier Insite FT PEEK Knotless Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device and may be used with specific USP Size #2 sutures.

The Tornier Insite FT PEEK Knotless Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and quidelines.

AI/ML Overview

The provided document [0-4] is a 510(k) premarket notification for the "Tornier Insite™ FT PEEK Knotless Suture Anchor." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to establish new safety and effectiveness criteria. As such, the document does not contain information about acceptance criteria or specific studies using AI/standalone algorithms or human-in-the-loop assessments as typically seen with software-as-a-medical-device (SaMD) submissions.

Therefore, many of the requested details are not applicable or available within this type of regulatory submission. The information below reflects what can be extracted from the provided text for a medical device that is not a software algorithm.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Mechanical Insertion Strength	Not explicitly stated, but implied to be sufficient for intended use and comparable to predicate devices.	"Results... indicate that the Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in performance and efficacy to the above cited predicate devices."
Fixation Strength	Not explicitly stated, but implied to be sufficient for intended use and comparable to predicate devices.	"Results... indicate that the Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in performance and efficacy to the above cited predicate devices."
Material (PEEK-OPTIMA®)	Biocompatibility and mechanical properties suitable for bone implant.	Device is made of PEEK-OPTIMA® material. Implicitly, this material is suitable given its use in the predicate device.
Design (fully threaded anchor)	Functionally equivalent to predicate devices for soft tissue to bone fixation.	Device is a fully threaded PEEK-OPTIMA® anchor, similar to predicate devices.
Sizing (4.5mm, 5.5mm, 6.5mm)	Appropriate range for various fixation applications.	Available in three sizes, matching the range for intended applications.
Sterilization (Ethylene Oxide)	Achieves sterility as per appropriate standards and guidelines.	"Sterilized through ethylene oxide (EO) using appropriate standards and guidelines."

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

Sample Size: Not specified as a separate test set in the context of device performance. The testing was comparative against predicate devices.
Data Provenance: Not explicitly stated. The testing was "Non-clinical laboratory testing and assessments." This usually implies in-house testing or contracted lab testing specifically for this submission, rather than clinical data from a specific country or setting. It is "retrospective" in the sense that it's performed for a submission, not a prospective trial.

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

Not applicable. This device is a physical bone implant, not a diagnostic or prognostic device requiring expert interpretation for ground truth establishment. Mechanical and fixation strength are quantifiable without expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or similar devices where human readers interpret data, often with and without AI assistance. This submission is for a physical orthopedic implant.

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

No, a standalone performance study was not done. This term is applicable to AI/software components. The device is a physical implant, not a software algorithm.

7. The type of ground truth used

For mechanical and fixation strength tests, the "ground truth" would be the objective measurements obtained through standard biomechanical testing methods, often compared against established industry standards or the performance of predicate devices. There is no pathology, outcomes data, or expert consensus used as ground truth in the context of this device's performance evaluation.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component requiring a training set.

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

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

Summary

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APR 0 4 2014

SECTION 5: 510(K) PREMARKET NOTIFICATION

510(k) Summary of Safety and Effectiveness Information

Tornier, Inc. Insite FT PEEK Knotless Suture Anchor

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1. Device name

Device name:	Tornier Insite™ FT PEEK Knotless Suture Anchor
Device:	Suture anchor
Classification name:	Smooth or threaded metallic bone fixation fastener
Classification number:	21 CFR § 888.3030; 888.3040
Product code:	MBI - Fastener, Fixation, Nondegradable, Soft Tissue

2. Submitter

Tornier Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 Registration Number: 9100540

3. Company contact

Mireille Lemery Tornier Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 Phone: +33 4 76 61 38 98 Fax: +33 4 76 61 35 65 Email: mireille.lemery@tornier.com

4. Classification

Device class: Class II

Classification panel: Orthopedic

Product code: MBI

Legally Marketed Device to which Equivalence is Claimed: ട്.

The Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Tornier, Inc. Insite FT Suture Anchor, K110773 and R6G Sports Medicine Knotless Anchor, K110230.

6. Device Description

The Tornier Insite FT PEEK Knotless Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor

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that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device and may be used with specific USP Size #2 sutures.

The Tornier Insite FT PEEK Knotless Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and quidelines.

7. . Materials

The Tornier Insite FT PEEK Knotless Suture Anchor is available in PEEK-OPTIMA® material.

8. Indications for Use

The Tornier Insite FT PEEK Knotless Suture Anchors are intended for fixation of soft tissue to bone.

The Tomier Insite FT PEEK Knotless Suture Anchors are intended for use in the following applications:

1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament 2. repair, Hallux Valgus and Midfoot reconstruction.
1. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
বঁ Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
1. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

9. Summary of Technologies

The technological characteristics (material, design, sizing, indications, sterilization, and fixation strength) of the Tomier Insite FT PEEK Knotless Suture Anchors are similar or identical to the cited predicate devices.

10. Nonclinical Testing

Non-clinical laboratory testing and assessments were performed; these are: mechanical insertion and fixation strength, as compared to the predicate devices, for the specific indications for use. The results of these tests indicate that the Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in performance and efficacy to the above cited predicate devices within their intended use.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

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 tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

April 4, 2014

Tornier, Incorporated Ms. Mireille Lemery Director, Global Regulatory Affairs 10801 Nesbitt Avenue South Bloomington, Minnesota 55437

Re: K133777

Trade/Device Name: Insite™ FT PEEK Knotless Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metailic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 2, 2014 Received: January 7, 2014

Dear Ms. Lemery:

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 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.

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Page 2 - Ms. Mircille Lemery

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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.

Ronald P. Jean -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133777

Device Name Insite PT PEEK Knotless Suture Anchor

Indications for Use (Describe)

The Tornier Insite FT PEEK Knotless Suture Anchors are intended for lixation of soft tissue to bone.

The Tornier Insite FT PEEK Knotless Suture Anchors are in the following applications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
Knee: Medial collateral and Lateral ligament repair, Patchar tendon and Posterior obligue ligament repair, Misothial band tenodesis.
Hand/Wrist: Scapholunate ligament Radial collateral ligament and Ultar collateral ligament reconstruction.
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CHANGE ON THE FOR FOR FOR FOR FDA USE ONLY A DE ONLY A DE LONG BE ONLY BE ON Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

page 1/1

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on lest pege.

FORM FDA 3881 (1/14)

Regulation Number and Section

N/A