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Phantom Fiber BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Tornier, Inc. Phantom Fiber BioFiber Suture is a n absorbable, braided, sterile, surgical USP size 2 suture composed of poly(4-hydrobutyrate) (P4HB) with cyanoacrylate adhesive tipped ends. Phantom Fiber BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.

Here's a breakdown of the acceptance criteria and study information for the Tornier, Inc. Phantom Fiber BioFiber Suture (K130422), based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Tornier BioFiber Suture K122487) through non-clinical testing. It does not describe an AI/ML-based device or associated clinical studies with human readers. Therefore, several requested sections are not applicable in this context.

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

• Sample Size: The document does not specify the exact sample sizes for the USP-compliant tests or the non-USP tests (in-vivo degradation, residual molecular weight).
• Data Provenance: Not specified. The testing appears to be laboratory-based (non-clinical).
• Retrospective/Prospective: Not applicable as it's non-clinical, non-human testing.

2. 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. The "ground truth" for the performance tests (e.g., tensile strength, diameter) would be the established USP standards themselves, measured by laboratory equipment, not by human experts.

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

• Not applicable. Adjudication methods are typically relevant for human-interpretable data (e.g., medical images) where there might be disagreement among reviewers. For physical performance tests, the measurements are objective.

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 device is a surgical suture, not an AI/ML-based diagnostic or assistive device that would involve human readers.

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

• Not applicable. This device is a physical medical device (suture), not an algorithm.

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

• The ground truth for the performance tests appears to be objective measurements against established industry standards (United States Pharmacopeia - USP). For the non-USP tests, "in-vivo degradation testing of product strength over time and residual molecular weight" would use laboratory measurements.

7. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is a physical medical device.

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