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The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions.

The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the port, and; the obturator which is a mechanism that allows the cannula to penetrate the abdomen. The trocars contained in this submission are bladeless. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.

The provided document is a 510(k) summary for a reprocessed medical device, specifically Reprocessed Ethicon Bladeless Trocars and Universal Trocar Sleeves. It does not describe an AI/ML-based device or a diagnostic algorithm, but rather a physical medical device that is reprocessed for reuse.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and training/test set data, which are typical for AI/ML-based diagnostic devices, is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the new Ethicon trocar) through:

1. Comparison of Technological Characteristics: Indications for Use, Materials, Design, Energy Source.
2. Performance Testing: Benchtop functional tests (Seal Drag, Seal Leakage, Insertion, Fixation, Removal Force Test), Product Stability (Shelf Life Testing), Cleaning Validation (Residual Protein and Hemoglobin, Visual Inspection, Cleaning Performance Qualification), Sterilization and Packaging (EtO Sterilization Testing, Simulated Shipment Testing), and Biocompatibility Testing.

The "acceptance criteria" for this device are that its performance, once reprocessed, is equivalent to that of a new, original equipment manufacturer (OEM) device. The study proving this involves side-by-side benchtop testing and cleaning validation.

To directly answer your prompt's questions based on the provided document, where applicable:

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

The document describes the types of tests performed and the overarching goal of demonstrating "substantial equivalence" to the OEM device. It doesn't provide specific numerical acceptance criteria (e.g., "Seal Drag < X Newtons") or quantitative reported performance values in a table format within this summary. Instead, it states: "Side by side testing ensured that the reprocessed trocars performed equivalently to the same device new from the OEM."

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

The document does not specify the sample sizes (number of reprocessed trocars) used for the functional, cleaning, or stability tests. The data provenance is implied to be laboratory/benchtop testing rather than clinical data from human subjects. Location of testing is not specified, but the submitter and contact person are in the USA. The testing is for a reprocessed device vs. a new OEM device.

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

Not applicable. "Ground truth" in the context of this device refers to the performance of a new OEM trocar, measured via engineering and biocompatibility tests, not expert interpretation of diagnostic images.

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

Not applicable. This is not a study involving human readers or subjective interpretations. Performance is measured objectively via benchtop tests.

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 is not an AI/ML device or a diagnostic reader study.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" for this reprocessed device is the performance characteristics of an unreprocessed, new OEM predicate device (Ethicon ENDOPATH® XCEL® Trocar with OPTIVIEW™ Technology, K122511), as measured through various functional, stability, biocompatibility, and cleaning tests.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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