(131 days)
Intended Use: The 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder.
Indications for Use: The Tornier Insite™ FT PEEK Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT PEEK Suture Anchors are intended for use in the following applications:
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Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Bicens tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
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Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
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Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
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Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
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Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
The Insite™ FT PEEK 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 two sizes (2.5mm & 3.5mm) for use in a range of fixation applications.
The provided document describes the 510(k) premarket notification for the 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchors. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with the specific criteria commonly found in AI/ML device evaluations.
Therefore, many of the requested details related to AI/ML model performance, such as sample sizes for test/training sets, expert qualifications, and specific AI-related study types (MRMC, standalone), are not applicable or not provided in this regulatory submission for a physical medical device (suture anchor).
However, I can extract the acceptance criteria and the methods used to prove the device meets these criteria as described in the "Performance Data" section.
Here's the information based on the provided text:
Acceptance Criteria and Device Performance for the 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchors
- A table of acceptance criteria and the reported device performance
| Validation and/or Verification Method | Acceptance Value/Criteria | Verification and Validation Results |
|---|---|---|
| Mechanical Testing (Suture Approximation and Tensile Pull-out) | To exceed strength of predicate device | Acceptable |
| Mechanical Testing (Cyclic Load Test) | To meet the physiological loading requirements | Acceptable |
| Mechanical Testing (Anchor Insertion Torque and Driver Torque to Failure Test) | To exceed the strength of the expected loading requirements | Acceptable |
| Mechanical Testing (Pull to Failure Testing) | To determine strength of predicate device (implicitly for comparison/equivalence) | Acceptable |
| Cadaver Lab Evaluation | Successful preparation in cadaveric specimens | Acceptable |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each mechanical test. The "Cadaver Lab Evaluation" mentions "cadaveric specimens," but the number is not specified.
- Data Provenance: Not specified, but likely laboratory bench testing ("Non-clinical performance bench testing").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a physical device undergoing mechanical testing, not an AI/ML model requiring expert-labeled ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Mechanical testing and cadaveric evaluations typically follow established engineering and surgical protocols, not multi-reader adjudication methods.
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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. This is a physical medical device, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" equivalent for this device is based on established engineering and biomechanical principles, predefined performance metrics derived from predicate devices, and physiological loading requirements. For the cadaveric evaluation, it's successful demonstration of preparation in a cadaveric model.
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The sample size for the training set
- Not applicable. This is not an AI/ML device relying on a training set.
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How the ground truth for the training set was established
- Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.