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The Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Atramat ® Synthetic Absorbable Polydioxanone Surgical Sutures are not indicated for use in adult cardiovascular, microsurgical, and neurological surgery uses.

Atramat ® Monofilament Polydioxanone are synthetic absorbable sterile surgical sutures composed of poly (p-dioxanone) synthetic polymer. These products are offered as monofilament or and it is offered uncoated or coated, it could also be undyed or dyed with D&C Violet No. 2.

The Atramat® Synthetic Absorbable Polydioxanone Surgical Suture is substantially equivalent to the Ethicon PDS II® Polydioxanone Synthetic Absorbable Polydioxanone Surgical Sutures. The substantial equivalence was proven by non-clinical testing.

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a number of sutures. The testing involved comparing the Atramat® PDO sutures directly against the requirements of USP 26 for absorbable surgical sutures.
• Data Provenance: Not applicable in a traditional sense of patient data. The tests were non-clinical, likely laboratory-based, and performed on the subject devices themselves. Country of origin for the data is not specified, but the submitter is based in Mexico.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for this non-clinical study was established by the universally recognized standards set forth in USP 26 (United States Pharmacopoeia). These are objective, published standards, not subjective expert consensus on individual cases.

4. Adjudication method for the test set:

• Not applicable. The determination of conformance to USP 26 standards is objective, based on laboratory measurements and comparison to defined physical and chemical criteria. No adjudication method involving human experts interpreting results was required.

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:

• No. This was a non-clinical study for a surgical suture, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are not relevant.

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

• No. This device is a surgical suture, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used:

• Standard-based Ground Truth: The ground truth for the non-clinical tests was established by the performance requirements and specifications detailed in the United States Pharmacopoeia (USP) 26 for absorbable surgical sutures.

8. The sample size for the training set:

• Not applicable. This was a non-clinical evaluation of a physical medical device against established standards, not a machine learning model requiring a training set.

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

• Not applicable, as there was no training set for a machine learning model.

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