The Tornier Insite FT Suture Anchor is intended for fixation of soft tissue to bone. The Tornier Insite FT Suture Anchor is intended for use 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 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 Titanium Suture Anchor w/ Needles consists of a bone implant device intended for the fixation of soft tissue to bone. The device is a fully threaded titanium suture anchor preloaded on a disposable inserter assembly, attached USP size#2-0 or USP size #0 UHMWPE suture and comes with needles attached to the ends of the suture. The Tornier Insite FT Titanium Suture Anchor w/ Needles is used as a means for securing soft tissue to bone. The implant is individually packaged and sterilized though ethylene oxide (EO) using appropriate standard and guidelines

AI/ML Overview

This is a medical device 510(k) summary for the Tornier Insite FT Suture Anchor with Needles, not an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data, is not available or applicable.

However, based on the provided document, I can extract information related to the acceptance criteria and study for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Pre-established)	Reported Device Performance
Cyclic Testing	Met pre-established criteria	Met pre-established criteria
Mechanical Insertion & Pullout Testing	Met pre-established criteria	Met pre-established criteria
Driver Torque Testing	Met pre-established criteria	Met pre-established criteria
Suture Needle Pull Testing	Met pre-established criteria	Met pre-established criteria
Cadaveric Laboratory Simulated Use Testing	Met pre-established criteria	Met pre-established criteria

Note: The document states "All tests met the pre-established acceptance criteria," but does not explicitly detail the quantitative values of these criteria. It implies that for each listed test, a specific performance benchmark was set, and the device successfully achieved or exceeded that benchmark.

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

Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing was performed" and "cadaveric laboratory simulated use testing," implying a physical testing methodology rather than a data-driven test set in the context of AI/ML. The number of physical units or cadavers used is not specified.
Data Provenance: The testing was "non-clinical laboratory testing" and "cadaveric laboratory simulated use testing." This indicates the data provenance is from laboratory experiments, likely conducted in a controlled environment. The country of origin for the cadavers or the testing facility is not specified.

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

This question is not applicable as this is a physical medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for a test set. The "ground truth" for this device would be its physical and mechanical performance characteristics against engineering and safety standards.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions on diagnostic images or data, which is not relevant here.

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

This question is not applicable as this is a physical medical device (suture anchor), not an AI/ML system designed to assist human readers (e.g., radiologists).

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

This question is not applicable as this is a physical medical device, not an algorithm. The "standalone performance" is simply the device's inherent mechanical and functional performance, which was evaluated through the non-clinical laboratory tests.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this medical device's performance is based on engineering specifications, biomechanical properties, and safety standards relevant to bone fixation devices. The document indicates that tests were performed "per design requirements and risk analysis." This would include metrics like failure strength, pullout strength, torque, and suture integrity, which are quantifiable engineering parameters.

8. The Sample Size for the Training Set

This question is not applicable as this is a physical medical device and does not involve a "training set" in the context of AI/ML. Device design and manufacturing processes are refined through engineering, material science, and iterative testing, not by training an algorithm on a dataset.

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

This question is not applicable as there is no "training set" or corresponding "ground truth" in the AI/ML sense for this physical medical device. The "ground truth" for the device's development would be established through established engineering principles, material science knowledge, and clinical requirements for soft tissue-to-bone fixation.

Summary

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K132632

TORNIER

510(k) Summary 4

510(K) Owner's Name:	Tornier Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, Minnesota 55437
Phone and Fax Numbers:	Phone: 952.426.7600Fax: 952.426.7601
Name of Contact Person:	Janell A. Colley
Date Prepared:	August 19, 2013
Trade or Proprietary Name:	Tornier Insite FT Suture Anchor with Needles
Common or Usual Name:	Smooth or threaded metallic bone fixation fastener
Classification Name:	Product Code: MBI21 CFR 888.3040
Legally Marketed Device toWhich Your Firm IsClaiming Equivalence:	K110773 - Tornier Insite FT Suture Anchor, cleared 2 June 2011K083268 - Tornier, Inc., Insite Suture Anchor, cleared 12 February 2009
Description of The Device:	The Tornier Insite FT Titanium Suture Anchor w/ Needles consists of abone implant device intended for the fixation of soft tissue to bone. Thedevice is a fully threaded titanium suture anchor preloaded on a disposableinserter assembly, attached USP size#2-0 or USP size #0 UHMWPE sutureand comes with needles attached to the ends of the suture.The Tornier Insite FT Titanium Suture Anchor w/ Needles is used as ameans for securing soft tissue to bone. The implant is individuallypackaged and sterilized though ethylene oxide (EO) using appropriatestandard and guidelines
Intended Use of the Device:	The Tornier Insite FT Suture Anchor is intended for fixation of softtissue to bone.The Tornier Insite FT Suture Anchor is intended for use in the followingapplications:Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis,Acromio-Clavicular separation and Deltoid repair, Capsular shift andCapsulolabral reconstruction.Foot/Ankle: Lateral and Medial stabilization, Achilles tendon andMetatarsal ligament repair, Hallux Valgus and Midfoot Reconstruction.Knee: Medial collateral and Lateral collateral ligament repair, Patellartendon and Posterior oblique ligament repair, Illiotibial band tenodesis.Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnarcollateral ligament reconstruction.Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radialcollateral ligament reconstruction.
TechnologicalCharacteristics ComparedTo Predicate Device:	The technological characteristics (material, design, sizing, indications,sterilization, failure strength) of the Tornier Insite FT Ti Suture Anchor w/Needles are substantially equivalent to the predicate devices.
Summary of theNonclinical TestsSubmitted:	Non-clinical laboratory testing was performed to evaluate the deviceperformance per design requirements and risk analysis, including cyclictesting, mechanical insertion and pullout testing, driver torque testing,suture needle pull testing, and cadaveric laboratory simulated use testing.All tests met the pre-established acceptance criteria
Conclusions Drawn Fromthe Nonclinical and ClinicalTests:	Based on risk analysis and acceptable results from testing, the TornierInsite FT Suture Anchor with Needles was found to be substantiallyequivalent to the predicate device

1 9 2013

10801 Nesbitt Avenue South

Bloomington, MN 55437

Phone: (952) 426-7600

. •

Fax: (952) 426-7601

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Tornier, Incorporated Ms. Janell Colley Regulatory Affairs Manager 10801 Nesbitt Avenue South Bloomington, Minnesota 55437

September 19, 2013

Re: K132632

Trade/Device Name: Tornier Insite FT Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Il Product Code: MBI Dated: August 19, 2013 Received: August 22, 2013

Dear Ms. Colley:

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

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Page 2 - Ms. Janell Colley

forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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,

Elizabeth L. Frank -S

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a bold, serif font. To the right of the word is a hexagonal shape containing a stylized letter "T" inside. The letter "T" within the hexagon is designed with a tree-like appearance, with the top of the "T" resembling branches.

Statement of Indications for Use 3
K132632 TBD -510(k) Number:

Device Name: Tornier Insite FT Suture Anchor

Indications for Use

The Tornier Insite FT Suture Anchor is intended for fixation of soft tissue to bone.

The Tornier Insite FT Suture Anchor is intended for use in the following applications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps ﻨــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and ni Metatarsal ligament repair, Hallux Valgus and Midfoot Reconstruction.
- 1. - IKnee: 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 ಳ Ulnar collateral ligament reconstruction.
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and 5. Radial collateral ligament reconstruction.

AND/OR Prescription Use X (Part 2) CFR 801 Subpart D)

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

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

Concurrence of CDRI-I, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Phone: (952) 426-7600 Bloomington, MN 55437

RESERVED FOR FUTURE USE

Regulation Number and Section

N/A