(73 days)
The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT Suture Anchors are 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.
The Tornier Insite™ FT Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) and two materials (PEEK-OPTIMA® and Titanium) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.
The Tornier Insite™ FT Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.
The Tornier Insite™ FT Suture Anchor is a medical device for affixing soft tissue to bone. The information provided outlines the non-clinical testing performed to demonstrate substantial equivalence to legally marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criterion for the Tornier Insite™ FT Suture Anchors was that they should provide equivalent fixation strength to the cited predicate devices. The study report states that:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent fixation strength to predicate devices for specific indications for use. | "The test results indicate that the Tornier Insite™ FT Suture Anchors provide equivalent fixation strength to the above cited predicate devices and would be functional within their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size used for the mechanical insertion and pullout testing. It only states that "Non-clinical laboratory testing was performed" and that "The efficacy of the Tornier Insite™ FT Suture Anchors were compared to the above cited predicates device."
Data provenance (country of origin, retrospective or prospective) is not explicitly mentioned. However, since this is a premarket notification (510(k)) for a medical device in the United States, the testing would typically be conducted to satisfy US regulatory requirements.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study involved non-clinical laboratory testing (mechanical insertion and pullout tests) to evaluate fixation strength. This type of testing typically relies on engineering and biomechanical measurements rather than expert human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focused on non-clinical mechanical testing, not on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This information is not applicable. The device is a physical suture anchor, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used in this study was mechanical and biomechanical measurements of fixation strength. This would involve quantifiable data obtained from pullout tests and insertion tests, comparing the new device's performance directly against the predicate devices.
8. Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this is a non-clinical mechanical test, not a machine learning or AI study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.