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The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the surgeon. The System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.

Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors between 7x to 20x to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing. The subject device has the same intended use and indications for use, and same technological characteristics as the predicate device, DEN230032. The Supermicro Needle Holder Suture Cut instrument has been added to the NanoWrist Instruments' portfolio.

This document describes a 510(k) submission for the Symani Surgical System, specifically for the addition of a new instrument called the Supermicro Needle Holder Suture Cut.

Here's an analysis of the acceptance criteria and study information provided, noting what is and isn't available in the document:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance tests conducted to demonstrate that the new instrument maintains the safety and effectiveness of the existing system. The reported performance is an overall conclusion of substantial equivalence.

Implied Acceptance Criteria and Reported Performance from the Text:

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

• Sample Size: Not specified. The document only lists "Simulated use test," "Gripping force & torque," and "Structural integrity tests" without detailing the number of test runs, materials used, or specific data points.
• Data Provenance: Not specified. It's implied that the testing was conducted by Medical Microinstruments, Inc. in Pisa, Italy, as that's their location, but no direct statement on data origin is provided. The study appears to be prospective testing of the new instrument's performance characteristics.

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. This device is a surgical instrument and the performance tests described (simulated use, gripping force & torque, structural integrity) are engineering and functional tests, not clinical studies requiring expert interpretation or ground truth establishment in the traditional sense of diagnostic imaging or AI performance. The assessment is against established device performance parameters and comparison to a predicate.

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

Not applicable. As described above, this is not a study requiring human adjudication of results in the context of diagnostic interpretation. The performance tests would be evaluated against engineering specifications and comparison to the predicate.

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-powered diagnostic device, but a surgical instrument. Therefore, MRMC studies and AI-assistance effect sizes are not relevant to this submission.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

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

Not applicable. The "ground truth" for the performance tests of a surgical instrument involves engineering specifications, material properties, mechanical testing standards, and comparison to the functionally equivalent predicate device's performance. There is no biological or diagnostic "ground truth" in this context.

8. The sample size for the training set

Not applicable. As noted, this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. No training set is involved.

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