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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.

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