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Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures.

ETHICON ENDOSUTURE System is comprised of two (2) parts, the ENDOSUTURE System ENDO-HOLDER Cannula Knot Pusher and the ENDOSUTURE System suture. Each is available separately for assembly at the surgical site. The ENDOSUTURE System ENDO-HOLDER is a one-piece stainless steel device designed to accept the ENDOSUTURE System suture. The ENDOSUTURE System ENDO-HOLDER is provided non-sterile for sterilization before initial use and is reusable. ENDOSUTURE System sutures are conventional sutures, the same suture materials available by ETHICON, Inc. allowed to be marketed by FDA. The ENDOSUTURE System suture is configured in either a loop or pre-tied with needle or a suture strand with needle. Pre-threaded to each ENDOSUTURE System suture is a plastic passer and slide component that is designed for loading the suture in the ENDOSUTURE System ENDO-HOLDER.

The provided text describes a medical device, the ETHICON ENDOSUTURE System, and its substantial equivalence to a predicate device. However, the information provided does not contain the level of detail required to answer all aspects of your request, particularly regarding specific acceptance criteria for performance metrics, detailed study results, or the involvement of experts in ground truth establishment.

Here's a breakdown of what can be extracted and what information is missing:

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

The document focuses on "substantial equivalence" and does not explicitly list acceptance criteria with pass/fail thresholds for specific performance metrics. Instead, it states that "Differences do not raise new questions of safety and effectiveness." and that "Benchtop evaluations were conducted on the sutures used in the ENDOSUTURE System to assess USP characteristics (diameter, knot tensile strength and needle pull-off). Comparative benchtop functionality testing was conducted to assess knot security following knot placement. Nonclinical laboratory testing was conducted to determine breaking strength retention."

While these are the types of tests performed, the specific numerical results or the acceptance criteria for those results (e.g., "knot tensile strength must be > X Newtons") are not provided in this summary.

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

This information is not provided in the document. It mentions "benchtop evaluations" and "nonclinical laboratory testing" but does not specify the number of samples tested or the origin of the data.

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)

This information is not provided in the document. The tests described are laboratory-based (benchtop, nonclinical) and do not appear to involve human interpretation needing expert ground truth establishment in the way an AI diagnostic tool would.

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

This information is not provided in the document. Given the nature of the described tests, adjudication by experts for a test set is not applicable.

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

An MRMC comparative effectiveness study was not done. This device is a surgical instrument (suture system), not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

This concept is not applicable to the described device. The device is a physical surgical tool and does not involve an algorithm.

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

For the benchtop and nonclinical laboratory tests, the "ground truth" would be established by scientific and engineering standards and measurements. This includes USP characteristics (diameter, knot tensile strength, needle pull-off), and objective measurements of knot security and breaking strength retention. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific performance evaluations.

8. The sample size for the training set

This concept is not applicable to the described device. The device is a physical surgical tool and does not involve a "training set" in the context of machine learning or AI.

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

This concept is not applicable to the described device.

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