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. The Energist NeoGen PSR generator. This incorporates a source of Ultra High Frequency (UHF) energy and the gas control system required to support creation of nitrogen plasma;
. A Footswitch – single pedal type for activation of the plasma output.
. A handpiece that connects to the generator via an umbilical, which incorporates electrical and gas connections. The handpiece incorporates a finger-operated button switch that can be used to activate the plasma as an alternative to the footswitch.
. A Procedure Pack, comprising one or more limited life disposable tips (nozzles) through which the plasma is delivered. These are a snap fit to the distal end of the handpiece;
A gas supply system - principally a nitrogen gas cylinder and a regulator assembly;
. A bespoke trolley which provides a secure, mobile platform for the generator, handpiece, gas cylinder (plus a spare cylinder) and gas regulator assembly.

AI/ML Overview

The provided text is a 510(k) Summary for the NeoGen PSR System, focusing on the addition of a 25mm nozzle option. It describes the device, its intended use, and a comparison to predicate devices, along with testing performed for safety and performance. However, this document does not contain details about acceptance criteria, reported device performance in terms of clinical outcomes, sample sizes for a test set, ground truth establishment, expert adjudication, or MRMC studies for improved reader performance with AI assistance.

The document is primarily a regulatory submission comparing the technological characteristics of the new 25mm nozzle to previously cleared devices. It states that the 25mm nozzle has been included in the scope of assessments, but these assessments are primarily for safety and electromagnetic compatibility (EMC), not clinical effectiveness in terms of specified acceptance criteria on patient data.

Here's a breakdown of what is and is not in the provided text:

1. Table of acceptance criteria and the reported device performance:

Not provided. The document discusses compliance with safety and EMC standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-2-2, IEC 60601-1-2) which are general device standards. It lists various technical parameters and how they compare between the predicate and subject device (e.g., Max Output Energy, Treatment Pulse Repetition Rate, Output Pulse Width, Safety Classification). However, these are specifications, not acceptance criteria for clinical performance (e.g., a specific reduction in rhytids by a certain percentage with a defined confidence interval). There are no reported device performance metrics against specific clinical acceptance criteria.

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

Not provided. The document mentions "Representative samples of the NeoGen PSR system have been tested" for safety and EMC, and "Representative samples of the NeoGen PSR system have been tested by Energist Limited UK to demonstrate compliance with the user and functional performance requirements." However, no sample sizes for these tests are given, nor is there any mention of a "test set" in the context of clinical data or data provenance (country of origin, retrospective/prospective). The tests described are laboratory-based safety and performance tests, not clinical studies with patient data.

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

Not applicable/Not provided. Since there is no clinical "test set" and no "ground truth" derived from patient outcomes, this information is not present. The document focuses on technical specifications and safety compliance.

4. Adjudication method for the test set:

Not applicable/Not provided. As there's no clinical test set or ground truth derived from expert review, adjudication methods are not relevant or discussed.

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/Not provided. The NeoGen PSR System is described as an electrosurgical cutting and coagulation device that delivers nitrogen gas plasma for dermatological conditions. It is a therapeutic device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant to this device.

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

Not applicable/Not provided. This device is a physical electrosurgical system operated by a medical practitioner. It does not involve an algorithm requiring standalone performance evaluation.

7. The type of ground truth used:

Not applicable/Not provided. No clinical ground truth (e.g., pathology, outcomes data) is mentioned as being used for evaluating the performance of the device against acceptance criteria in the clinical context. The "compliance" mentioned is against engineering and safety standards.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable/Not provided. As above, no training set or ground truth for it exists for this device.

In summary, the provided FDA 510(k) summary is a regulatory document affirming substantial equivalence based on technological characteristics and compliance with recognized safety and performance standards for an electrosurgical device. It does not delve into clinical efficacy studies with acceptance criteria, human reader performance, or AI considerations, which are typically found in the context of diagnostic or AI-powered devices. The "study that proves the device meets the acceptance criteria" in this document refers to engineering and safety testing, not clinical trials with patient cohorts.

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