Search Results

The Tornier CINCH™ Knotless Fixation Implant is intended for fixation of soft tissue to bone.

The CINCH™ Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

The CINCH™ Knotless Fixation Implant System includes a 3.5 mm diameter bone anchor and a disposable preloaded anchor Inserter. The CINCH™ Knotless Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The CINCH™ system includes a Suture Loading Assembly that is attached to the distal end of the Inserter Handle. The CINCH™ Bone Anchor is a knotless fixation device eliminating the need for surgical knots. The device is designed for inserting the implant directly into bone without a pre-drilled, punched, or tapped pilot hole.

The CINCH™ Anchor configuration is comprised of a curved nitinol base, a flared nitinol clip, two titanium rings and a titanium cross pin. The CINCH™ Anchor is 12.9 mm long from rings to tip and 3.5 mm in diameter prior to wing deployment and 7.4 mm wide with wings expanded.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. This submission, K080335, is a 510(k) summary, which focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving specific performance against acceptance criteria in a clinical study.

The document states: "This submission supports the position that the Tornier CINCH™ Knotless Fixation Implant System is substantially equivalent to a number of pre-enactment and previously cleared devices, including those listed above. A number of the referenced predicate devices list the same range of clinical uses."

And "Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier CINCH™ Knotless Fixation Implant System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines."

This indicates that the device's acceptance is based on its similarity to existing, legally marketed devices and that it has been tested according to general FDA guidelines, not against specific performance acceptance criteria from a dedicated study detailed in this document.

Therefore, I cannot populate the requested table or answer the questions related to a specific study from this document.

Ask a specific question about this device

The CINCH™ Knotless Fixation Implant System is intended for the fixation of soft tissue to bone during rotator cuff repair.

The CINCHT™ Knotless Fixation Implant includes single-use, sterile Anchor (3.5mm in diameter), which is preloaded onto a disposable anchor inserters. The CINCH™ Knotless Fixation Implant System is comprised of nondegradable suture anchors each pre-loaded onto an inserter.

The provided text describes a 510(k) submission for a medical device, the CINCHT™ Knotless Fixation Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study or AI performance metrics.

Therefore, many of the requested categories for AI/clinical study performance data are not applicable to this document. The submission focuses on bench testing and comparison to existing devices.

Here's a breakdown of what can be extracted and what is N/A:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give specific numbers of tests or implants used.
• Data Provenance: Not specified, but generally, bench testing for a 510(k) submission would be conducted by the manufacturer (C2M Medical, Inc. in San Antonio, Texas, USA) or a contracted lab. This is a retrospective analysis of the device's characteristics against its design.

3. 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. For a medical device 510(k) submission based on bench testing, "ground truth" is established by engineering and materials science principles and validated through empirical measurements (bench testing), not by expert consensus in the way AI models define it.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are typically used in clinical trials or for establishing ground truth for AI models with human interpretation. This document describes bench testing.

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

• Not Applicable. This is a medical device (surgical implant), not an AI-powered diagnostic or assistive tool.

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

• Not Applicable. This is a medical device (surgical implant), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Bench Testing Results / Engineering Specifications: The "ground truth" for this device's performance is its ability to meet engineering specifications and function as intended during bench tests. This is a physical or mechanical "ground truth."

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. As above, no AI model, no training set, no ground truth to establish for a training set.

Ask a specific question about this device