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The Arthrex LoopLocTM Knotless Suture is intended for soft-tissue approximation for hip capsular closure.

The Arthrex LoopLoc™ Knotless Suture is an all-suture device intended for use in soft-tissue approximation for hip capsular closure. This device is composed of a nonabsorbable suture implant and shuttling suture that are braided polyblend sutures (Arthrex size #2) made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) sutures, and preloaded on a single-use high-density polyethylene (HDPE) card with a disposable suture threader made of low-density polyethylene (LDPE), stainless steel, and Nitinol wire.

This 510(k) premarket notification is for the Arthrex LoopLoc™ Knotless Suture. The submission does not describe an AI medical device or an algorithm-driven diagnostic tool. Therefore, the information requested regarding acceptance criteria and study design for an AI/algorithm-based device, such as ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, is not applicable to this submission.

The acceptance criteria and supporting study for the Arthrex LoopLoc™ Knotless Suture are focused on demonstrating its physical performance and biocompatibility as a surgical suture, rather than diagnostic accuracy or algorithmic performance.

Here's the relevant information based on the provided document:

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

The document broadly states that the device meets performance specifications and is substantially equivalent to predicate devices. Specific quantitative acceptance criteria and detailed reported performance values are not explicitly laid out in a table format within this summary, but rather described in terms of testing conducted and conclusions drawn.

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

The document mentions "Cyclic and ultimate load testing" and "Bacterial endotoxin per EP 2.6.14/USP " but does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified, as these are bench tests on manufactured devices, not clinical data from patients.

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. This is a medical device (suture) and the testing involves mechanical and biocompatibility assessments, not a diagnostic or AI-driven system requiring expert consensus for "ground truth." The "ground truth" here is objective physical and chemical properties and performance.

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

Not applicable, as this is not a diagnostic device or a study involving human interpretation of data for ground truth establishment.

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 device.

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

Not applicable. This is not an AI device.

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

For the mechanical testing, the "ground truth" would be the direct measurement of physical properties (e.g., load to failure, cyclic fatigue resistance) performed according to established engineering standards relevant to surgical sutures. For the biocompatibility testing (bacterial endotoxin), the "ground truth" is whether the endotoxin levels meet predefined specifications. These are objective measurements rather than subjective assessments requiring expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. This is not an AI device.

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