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When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions :

• · Treatment of wrinkles and rhytids
• · Superficial skin lesions
• · Actinic Keratosis
• Viral Papillomata
• · Seborrheic Keratosis
• · Acne Scars

When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures.

The system comprises the following major elements:

• . 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.

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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The NeoGen PSR System is intended for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides .
• Superficial skin lesions .
• Actinic Keratosis .
• Viral Papillomata .
• Seborrheic Keratosis .
• Acne Scars .

The NeoGen System is an electro-surgical device intended for use in dermatological applications by trained and duly qualified medical practitioners in hospitals and clinics. Treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis. Similar biological changes to those from established laser-based dermatological surgical and skin resurfacing technologies are produced. A NeoGen PSR system comprises: NeoGen PSR generator, Footswitch, Handpiece/Cable Assembly, Procedure Pack (disposable nozzles), Nitrogen gas cylinder (not supplied). UHF energy from the Generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin.

The provided text describes the Energist Ltd NeoGen PSR System, an electrosurgical device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically associated with AI/ML device performance studies (e.g., sensitivity, specificity, AUC).

Instead, this document is a 510(k) summary (K132754), which is a premarket notification for a medical device seeking clearance from the FDA. The primary objective of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to perform a rigorous performance study against specific clinical acceptance criteria for a novel algorithm.

The core argument for substantial equivalence is based on:

• Identical Intended Use: The NeoGen PSR System has the same intended use as its predicate, the Portrait PSR System (K082197).
• Identical Technological Characteristics (with minor modifications): The device's technological characteristics are largely identical to the predicate, with minor modifications to the user interface, software, and outer casing design. The document states these differences "do not result in differences in performance or raise new questions of safety and efficacy."
• Equivalent Principles of Operation and Energy Outputs: The device has the same principles of operation, mode of action, and equivalent energy outputs as the predicate device.
• Compliance with Safety Standards: The device underwent testing to established international (IEC) and European (EN) safety standards for medical electrical equipment (IEC 60601-1, EN 60601-1, IEC 60601-2-2).
• Laboratory Validation & Verification: This was undertaken to ensure design specifications were met and were substantially equivalent to the predicate.

Therefore, many of the requested categories for a typical AI/ML device performance study are not applicable or explicitly mentioned in this 510(k) summary.

Here's an attempt to fill out the table and answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
| :-------------------------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Safety and Efficacy (General) | "minor differences to the systems do not raise additional concerns of safety and efficacy." (This is a conclusion rather than a specific criterion.) | "The NeoGen PSR System is therefore concluded to be substantially equivalent to the above named predicate device and minor differences to the systems do not raise additional concerns of safety and efficacy." |
| Compliance with Standards | Adherence to relevant medical device safety standards. | "IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007)", "EN 60601-1:2006 + A11:2011", "IEC60601-2-2:2009 (Fifth Ed)" were performed. The device is classified as "Class 1 (BS EN 60601-1:2006)" and "Type BF Applied Part". |
| Functional Equivalence to Predicate | Displayed Values Precision (Energy setting): 0.1 Joule. Max Output Energy: 4J. Treatment Pulse Repetition Rate: 1.0 to 2.5 Hz in Repeat Pulse mode; Single Pulse mode selectable. Pulse Width: Varied between 5.2 and 15.4 ms. RF Output Frequency: 2450 to 2480 MHz, typically 2470 MHz. Modulation: Pulsed CW. | The comparison table explicitly states that the NeoGen PSR System matches the predicate (Portrait PSR System) for all these specifications:

• Displayed Values Precision (Energy setting): 0.1 Joule.
• Max Output Energy: 4J.
• Treatment Pulse Repetition Rate: 1.0 to 2.5 Hz in Repeat Pulse mode; Single Pulse mode selectable.
• Pulse Width: Output RF pulse width is varied between 5.2 and 15.4 ms according to the energy to be delivered by each RF pulse.
• RF Output Frequency: 2450 to 2480 MHz, typically 2470 MHz; No sub-harmonics.
• Modulation: Pulsed CW (Carrier Wave). |
  | Reproducible Tissue Effects | "The NeoGen System provides a predictable depth of thermal modification so limiting unwanted effects that may result in scarring." (This is a statement of desired outcome, implying it's an unstated criterion.) | "Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects." "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." "The range of treatment energies and associated delivery times available has been determined from pre-clinical, clinical studies and expert opinion as being safe and effective for the intended applications..." |
  | Clinical Efficacy (implicitly) | The intended uses (treatment of wrinkles/rhytides, superficial skin lesions, actinic keratosis, viral papillomata, seborrheic keratosis, acne scars) are implicitly a clinical acceptance criterion, met by being substantially equivalent to a device already cleared for these indications. | "The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis." "Similar biological changes to those from established laser-based dermatological surgical and skin resurfacing technologies are produced." "The range of treatment energies and associated delivery times available has been determined from pre-clinical, clinical studies and expert opinion as being safe and effective for the intended applications when employed by a dermatologist, plastic surgeon or other suitably qualified user." |

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

• The document describes "Laboratory Validation & Verification" and refers to "pre-clinical, clinical studies and expert opinion" for determining the range of treatment energies and associated delivery times. However, no specific details on sample sizes for test sets, data provenance (country, retrospective/prospective), or subjects are provided for these studies. The focus is on demonstrating technical equivalence and safety compliance, not a novel clinical efficacy study with a defined test set.

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)

• The document mentions "expert opinion" contributed to determining the safe and effective range of treatment energies. No specific number or qualifications of experts are provided. No ground truth in the sense of AI/ML evaluation (e.g., labeling images) is discussed.

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

• Not applicable as no AI/ML test set requiring adjudication for ground truth is described.

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

• No MRMC study was done, as this is not an AI/ML device assisting human readers. The device itself performs the treatment.

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

• This is not an algorithm-only device. It's an electrosurgical system that is operated by a "trained and duly qualified medical practitioners." The "performance data" refers to the system's ability to produce specific physical outputs (energy, pulse width, frequency) and its compliance with safety standards, not an algorithm's diagnostic or predictive performance.

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

• For the technical validation, the "ground truth" would be the expected physical outputs and safety parameters as defined by the design specifications and relevant standards.
• For the "pre-clinical, clinical studies and expert opinion" mentioned, the "ground truth" for efficacy would likely be based on clinical observations, histological analysis (pathology, although not explicitly stated), and physician assessment of patient outcomes. However, details are not provided.

8. The sample size for the training set

• Not applicable; this is not an AI/ML device that requires a "training set" in the computational sense. The "pre-clinical, clinical studies and expert opinion" inform the device's design and operating parameters, which is analogous to "training" in a broad sense, but specific sample sizes are not given.

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

• As per point 8, not applicable in the AI/ML sense. The "ground truth" for the device's design and operational parameters comes from established medical literature, clinical experience, and expert opinion in the field of dermatological treatments using energy-based systems, as implied by the statement: "The User should be familiar with the medical literature, complications and hazards associated with the use of light-based and other energy systems..." and "The range of treatment energies...has been determined from pre-clinical, clinical studies and expert opinion."

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