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The PlasmaJet® system is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.

The PlasmaJet® system comprises: a) PlasmaJet® console (Version 3-Plus), b) PlasmaJet® service module, c) PlasmaJet® open surgery handpieces, and d) PlasmaJet® laparoscopic surgery handpieces. It is a neutral plasma surgery system. The latest version of the PlasmaJet® console (Version 3-Plus) features rapidly pulsed plasma in a so-called "Ultra" mode that provides optimal cutting and coagulation capability.

The provided document is a 510(k) summary for the Plasma Surgical PlasmaJet® System (Version 3-Plus). This document focuses on demonstrating substantial equivalence to predicate devices for a surgical tool used for cutting, coagulation, and tissue vaporization. It does not describe a study involving acceptance criteria for a device performance that would typically be described by metrics like sensitivity, specificity, or F1-score, as these are usually associated with AI/ML-driven diagnostic or predictive devices.

Instead, the submission relies on pre-clinical and tissue studies to establish that the PlasmaJet® system provides safe and effective cutting, coagulation, and removal of soft tissue by vaporization, with minimal damage to underlying tissue, equivalent to predicate devices. The "acceptance criteria" in this context are implicitly that these studies confirm the new device's performance aligns with the established safety and effectiveness of its predecessors.

Therefore, many of the requested elements regarding sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of medical device submission.

Here's a breakdown of the relevant information provided:

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

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

• Sample size: Not specified. The document mentions "Pre-clinical and tissue studies" but does not provide details on the number of tissue samples or subjects used in these studies.
• Data provenance: Not specified. This type of submission typically focuses on technical characteristics and comparative studies rather than clinical trial data provenance in the same way as an AI/ML device. The studies were likely conducted internally or by a contracted lab.

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

• Number of experts and qualifications: Not specified. Ground truth for these types of "pre-clinical and tissue studies" would typically be established by laboratory analysis, histological examination, and potentially expert assessment of the surgical effect by veterinarians or specialized pathologists, but no details are provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This concept is typically relevant for studies where multiple human readers assess data independently and discrepancies need to be resolved. For pre-clinical and tissue studies, the "ground truth" is derived from direct experimental observation and analysis.

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

• MRMC study: No. This is a surgical device, not a diagnostic or AI-assisted interpretation device. The concept of human readers improving with or without AI assistance is not relevant to this submission.

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

• Standalone study: Not applicable. This device is a surgical tool, which by its nature is used with a human in the loop (a surgeon). There is no "algorithm only" performance to evaluate in this context.

7. The type of ground truth used

• Type of ground truth: Based on the "pre-clinical and tissue studies" mentioned, the ground truth would have been established through direct observation of the surgical effect on tissue, potentially including histopathology or other laboratory analyses to assess cutting, coagulation, vaporization effectiveness, and damage to surrounding tissue.

8. The sample size for the training set

• Sample size: Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense.

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

• Ground truth for training set: Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process.

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