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The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle:

· Medial or lateral instability repairs/reconstructions

· Achilles tendon repairs/reconstructions

The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.

The provided text is a 510(k) summary for the Smith & Nephew Q-FIX® ULTRA All-Suture Anchor. This document describes a medical device and its equivalence to existing legally marketed devices, primarily through bench testing. It does not describe an AI/ML powered device, nor does it involve a study with human readers, ground truth establishment, or typical AI acceptance criteria.

Therefore, many of the requested fields cannot be populated as they are not applicable to this type of device submission.

Here's the information that can be extracted, and explanations for why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed."

However, the specific numerical acceptance criteria and the quantitative results for each test are not provided in this summary. The summary only states that the device "met all required specifications" and that "Results for all tests passed."

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is a non-clinical bench study on a physical medical device. There is no "test set" in the context of an AI/ML algorithm. The "test set" would refer to the number of physical devices or constructs tested for each bench test. This information is not provided in the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. There is no "ground truth" to establish for a physical medical device bench test in the context of human expert review. The evaluation criteria are based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" required for physical device bench testing in the context of human expert disagreement.

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 not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of device, the "ground truth" for performance is based on established engineering principles, material properties, and biomechanical standards against which the device's physical performance is measured.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device. There is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML powered device. There is no "training set" or ground truth in the AI context.

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