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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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The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

• Intense Pulsed Light Energy / wavelengths (530 950nm) .
  The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.

Intense Pulsed Light Energy / wavelengths (610 - 950nm)

The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

• Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily discusses the regulatory approval of the Energist ULTRAPLUS™ VPL Intense Pulsed Light System and lists its indications for use.

This document does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in your prompt. Therefore, I cannot extract the requested information from this text.

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The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

• Intense Pulsed Light Energy / wavelengths (530 - 950nm) .
  The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea. melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins. facial veins and venous malformations.

Intense Pulsed Light Energy / wavelengths (610 - 950nm) .

The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

The Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm. The system is designed to be compact and self contained and includes the following features:

• . Control console unit
• Display panel .
• Power supply ◆
• Cooling system .
• . Removable handpiece with integrated switch, lamp, filter and glass coupling block

Here's an analysis based on the provided text:

Based on the provided 510(k) summary, the Energist ULTRA Variable Pulsed Light (VPL™) System did not undergo a study to prove it met specific quantitative acceptance criteria in the manner described in your request. Instead, the submission relies on demonstrating substantial equivalence to previously legally marketed predicate devices.

The document states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." However, it does not detail the specific performance criteria or the results of such data.

Therefore, the requested tables and detailed study information for acceptance criteria cannot be fully extracted from the provided text, as this type of information is generally not required for a 510(k) submission when substantial equivalence is the primary pathway.

Here's what can be inferred or stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific clinical outcomes, percentages of reduction, safety thresholds). The implicit acceptance criteria are that the device performs equivalently to the predicate devices in terms of intended use and technological characteristics, and that any modifications do not raise new questions of safety or efficacy.
• Reported Device Performance: The document only generally states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." No specific quantitative performance results are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

No information is provided about a specific clinical "test set" with a defined sample size for the device's performance. The submission relies on equivalence to predicate devices, which would have had their own clinical data for market clearance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as a de novo clinical study with expert ground truth establishment for this specific device's clinical performance is not described.

4. Adjudication Method:

Not applicable, as a de novo clinical study with expert adjudication is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of an MRMC study. This type of study is more common for diagnostic imaging AI systems comparing human readers with and without AI assistance, which is not the nature of this device.

6. Standalone Performance Study:

No mention of a standalone performance study in the context of clinical outcomes to establish effectiveness. The "performance data" mentioned is likely related to engineering and output parameters rather than clinical efficacy.

7. Type of Ground Truth Used:

Not applicable for this 510(k) summary, as it does not describe a new clinical study for this device where "ground truth" for clinical outcomes would be established for the purpose of a novel efficacy claim.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/Machine Learning device that utilizes a "training set" in the conventional sense.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as the device is not an AI/Machine Learning system with a "training set."

Summary of 510(k) Substantial Equivalence Approach:

The Energist ULTRA VPL™ System's clearance is based on demonstrating substantial equivalence to two predicate devices: McCue Energist ULTRA™ (K040659) and Cyden IFL Professional System (K050165).

• Identical Intended Use: The new device claims an "identical intended use" to the McCue predicate device.
• Identical Technological Characteristics (with minor differences): The new device claims "identical technological characteristics" to the McCue predicate, except for "modifications to the device software and high voltage component." The key assertion is that "These differences do not result in differences in performance or raise new questions of safety and efficacy."
• Equivalent Principles, Mode of Action, and Energy Outputs: For the treatment of Acne Vulgaris, the device is stated to have "the same principles of operation, mode of action and equivalent energy outputs" as the Cyden predicate device.

Therefore, the "study" proving the device met "acceptance criteria" was implicitly the comparison to the predicate devices and the argument that its minor modifications did not negatively impact safety or efficacy, supported by general "performance data" (likely engineering/bench testing) showing it could achieve output parameters.

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