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L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

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The provided document is a 510(k) summary for the L-25 Absorbable Surgical Suture, which is a traditional medical device (suture) and not an AI/ML powered medical device. Therefore, the questions related to AI/ML powered medical device performance, such as acceptance criteria based on AI performance metrics (e.g., sensitivity, specificity, AUC), sample size for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, and MRMC studies, are not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a surgical suture.

Here's a breakdown of the available information based on the request, noting where information is not applicable:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics typical for AI/ML devices. For a surgical suture, acceptance criteria would generally relate to biocompatibility, tensile strength, absorption profile, knot security, and sterility, often benchmarked against predicate devices and relevant standards. The "Performance (Clinical & Non Clinical) and Biocompatibility" section, though not provided in full, would likely contain this information.
   • Reported Device Performance: Not provided in the excerpt in a quantitative table format. The document states that "Comparison of the L-25 absorbable surgical suture with the predicate devices provides confirmation of substantial equivalence." This implies that the performance of the L-25 suture was found to be comparable to the predicate devices across relevant characteristics.

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

   • Not Applicable: This device is a surgical suture, not an AI/ML powered device that would typically have a "test set" for algorithm evaluation in the sense implied by the question. Performance data would stem from material testing, animal studies, and potentially clinical studies, but not an "AI test set."

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: There is no "ground truth" establishment in the context of an AI test set for this device. Ground truth for a surgical suture would refer to established scientific and clinical standards for its physical properties and biological interactions.

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

   • Not Applicable: This concept is irrelevant to a surgical suture.

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 device is not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.

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

   • Not Applicable: This concept is irrelevant to a surgical suture.

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

   • Not Applicable (in the AI context): For a surgical suture, "ground truth" would be the established scientific and clinical parameters for evaluating its performance (e.g., ASTM standards for tensile strength, ISO standards for biocompatibility, histological assessment in animal models for absorption). The document implies that the L-25 suture's performance was compared to these established benchmarks and predicate devices.

8. The sample size for the training set

   • Not Applicable: This device is a surgical suture; there is no "training set" in the context of AI/ML.

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

   • Not Applicable: This concept is irrelevant to a surgical suture.

Summary of what can be extracted from the document regarding substantial equivalence for this type of device:

The document focuses on demonstrating Substantial Equivalence (SE) of the L-25 Absorbable Surgical Suture to existing predicate devices (K885018: Gut Suture (Surgigut™), K000037: Biosyn™ Suture, K944110: Vicryl™ Rapide Suture).

• Indications for Use: The L-25 suture is indicated for "general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery," which are the same indications as at least one of the predicate devices.
• Materials: Composed of Glycolide, Caprolactone, Tri-Methylene Carbonate, and Lactide polymers, which are common components in absorbable synthetic sutures and likely similar to those found in the predicate devices.
• Performance (Clinical & Non-Clinical) and Biocompatibility: The document states that "Comparison of the L-25 absorbable surgical suture with the predicate devices provides confirmation of substantial equivalence." This implies that the L-25 suture's performance characteristics (e.g., tensile strength, absorption profile, knot security, degradation products, tissue reaction) were tested and found to be comparable to the predicate devices. Detailed results are not included in the provided excerpt but would be part of the full 510(k) submission. These tests would adhere to recognized standards for surgical implants and sutures.
• Acceptance Criteria (Implied): For a traditional device like a suture seeking 510(k) clearance, the primary "acceptance criterion" is sufficient evidence to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is typically shown through comparative performance data against the predicate, adherence to relevant industry standards, and biocompatibility testing. The FDA letter confirms that the device was found substantially equivalent.

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