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TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

"TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia "Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.

The provided documents describe a 510(k) submission for a nonabsorbable polyester surgical suture called "TRUBOND". The submission aims to demonstrate substantial equivalence to existing predicate devices rather than proving novel effectiveness. Therefore, the information provided focuses on comparative testing against recognized standards (USP 26) rather than a clinical study with human readers or AI.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TRUBOND suture are defined by meeting or exceeding the specifications outlined in the United States Pharmacopeia (USP) current edition USP26. The reported device performance indicates that the TRUBOND suture meets or exceeds these USP specifications.

Study Information

The document describes no clinical study in humans or AI performance study that meets the criteria of your request (e.g., MRMC, standalone algorithm performance). The "study" referenced is a series of tests performed on the device to comply with regulatory standards and demonstrate equivalence to predicate devices.

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

• Sample Size: Not specified. The document states "Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility". This implies that multiple samples of the TRUBOND suture were tested for each characteristic, but the exact number of samples (test set size) is not provided.
• Data Provenance: The tests were conducted internally by Sutures India Pvt. Ltd. to demonstrate compliance with USP 26 standards for their TRUBOND suture. The data origin is thus the manufacturing and testing facility of the applicant. It is a prospective set of tests designed specifically for this submission.

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):

• No experts were explicitly mentioned for establishing ground truth in the context of clinical interpretation or diagnostic accuracy.
• The ground truth for the test set characteristics (e.g., diameter, tensile strength) is defined by the objective, quantitative specifications of the USP 26 monograph. The "experts" in this context would be the technicians or engineers performing the physical and chemical tests according to established USP methodologies. Their qualifications are not specified but would typically involve training in quality control and laboratory testing procedures for medical devices.

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

• None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there's a need to resolve discrepancies between human readers. For the physical and chemical tests performed on the suture, the results are quantitative and objective, based on standardized measurement techniques. Discrepancies would involve re-testing or calibration issues rather than expert adjudication.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices involving human interpretation of data. The TRUBOND suture is a physical medical device, not a diagnostic algorithm.

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

• No, a standalone algorithm performance study was not done. This applies to AI algorithms and is not relevant for a surgical suture.

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

• The ground truth for the device's characteristics (diameter, tensile strength, sterility, etc.) is the objective, quantitative specifications and methodologies defined by the United States Pharmacopeia (USP) current edition USP26. For biological compatibility, the ground truth is established by ISO-10993 standards. These are established, recognized regulatory standards for medical device properties.

8. The sample size for the training set:

• Not applicable. There is no mention of an algorithm or AI model, thus no training set or sample size for training is relevant. The manufacturing process of the suture itself might be considered "trained" through years of industrial practice, but this is not a "training set" in the context of AI.

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

• Not applicable. As there is no training set for an AI/algorithm, no ground truth was established for it.

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