Search Results

The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart repairs SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot/Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Midfoot reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Illiotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

The TWINFIX Ultra HA is a suture anchor manufactured from PLLA-HA and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter.

The provided document is a 510(k) summary for the Smith & Nephew TWINFIX Ultra HA Suture Anchor. It details the device's intended use and a comparison to predicate devices, but it does not contain the specific information required to answer the prompt regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document states: "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra HA suture anchors are substantially equivalent to the predicates; Twinfix AB 5.0 cleared via K011299 and the Twinfix AB 6.5 cleared via K032197."

However, it does not provide the actual acceptance criteria or the reported device performance metrics from these tests. It only makes a general statement about substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as requested.

Ask a specific question about this device

Reattachment of soft tissue to bone

Indications for Use:

Shoulder:

1. Bankart Lesion Repair
2. SLAP Lesion Repair
3. Acromioclavicular separation repairs
4. Rotator Cuff Repair
5. Capsular shift or capsulolabral reconstruction
6. Biceps tenodesis
7. Deltoid Repair

Foot and Ankle:

1. Hallux Valgus repair
2. Medial or Lateral instability repairs/reconstruction
3. Achilles tendon repair/reconstruction
4. Midfoot reconstruction
5. Metatarsal ligament/tendon repairs/reconstruction

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstruction
2. Ulnar or radial collateral ligament reconstruction
3. Lateral epicondylitis repair
4. Biceps tendon reattachment

Knee:

1. Extra-capsular Repairs:
   1a. Medial Collateral Repair
   1b. Lateral Collateral Ligament
   1c. Posterior Oblique Ligament
2. Iliotibial band tenodesis
3. Patellar realignment and tendon repairs, including vastus medialis obliquos advancement

The Twin Fix AB 6.5 mm anchor is a bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached.

I am sorry, but the provided text describes a medical device (Twin Fix AB™ 6.5 mm suture anchor) and its intended use, along with regulatory information, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device. It lists:

• The device's name, common name, and classification.
• The predicate device.
• A description of the device.
• Its intended use and specific indications for use across different anatomical areas.
• A statement of comparison of technological characteristics, asserting it is "identical in design, operating principle, material and intended use" to the predicate device.
• The FDA's decision letter of substantial equivalence.

Therefore, for the information you requested, I can only state the following based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text.
2. Sample size used for the test set and the data provenance: Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.
4. Adjudication method for the test set: Not available in the provided text.
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, as this is a physical medical device (suture anchor), not an AI/imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not available in the provided text.
8. The sample size for the training set: Not applicable, as this describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable, as this describes a physical medical device, not a machine learning model.

This type of 510(k) submission for a Class II device like a suture anchor typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive new clinical trial data with acceptance criteria for device performance. The "study" mentioned would likely refer to bench testing and material characterization to ensure consistency with the predicate, which is not detailed in this summary.

Ask a specific question about this device