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Smith & Nephew TWINFIX Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.

Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs

Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions

Elbow. Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral ligament repair, Posterior oblique ligament, lliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement

The Smith & Nephew TWINFIX* Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL are designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL consists of a titanium alloy suture anchor and non-absorbable sutures with attached stainless steel needles. The non-absorbable sutures are offered either braided, silicone or PTFE impregnated, polyester (USP) or braided, uncoated, UHMW polyethylene and UHMW polyethylene with monofilament polypropylene or nylon co-braid. An insertion device is also offered which contains a stainless steel shaft with a ABS and polycarbonate handle. The TWINFIX Ti is designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique.

Here's an analysis of the provided text regarding the Smith & Nephew TWINFIX Ti 3.5 Suture Anchor's acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Study Details

The provided text does not describe a study involving AI or software performance, but rather a traditional medical device 510(k) submission for a physical surgical anchor. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types related to AI) are not applicable.

Here's what can be extracted from the provided document:

1. Sample size used for the test set and the data provenance: Not applicable. The document refers to "Mechanical test data" but does not specify sample sizes or data provenance in terms of origin or retrospective/prospective nature. This generally refers to bench testing performed in a laboratory setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a mechanical device, ground truth is established through physical measurements against defined engineering specifications.

3. Adjudication method for the test set: Not applicable.

4. 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 not an AI-enabled device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used: For a mechanical device, the ground truth is established by engineering specifications and validated testing methods (e.g., ASTM standards or internal protocols) for physical properties like insertion force, pull-out strength, fatigue, etc.

7. The sample size for the training set: Not applicable. There is no AI training set for this physical device.

8. How the ground truth for the training set was established: Not applicable.

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