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The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.

The 308nm UV Phototherapy System is available in four models, UV-K , UV-Y and UV-Z. It is a portable medical device, which consists of LED light board, heat dissipation module, control circuit, drive circuit, battery (applicable to UV-X, UV-Z), and power adapter. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders, which can be used in hospital, clinics and households.

The device is mainly composed of a host and a power adapter. The LED light board of the device host contains light emitting diodes (LEDs), which create narrowband UVB light centered at a wavelength 308nm(±2nm) for the purpose of phototherapy. They are intended to be use in localized phototherapeutic treatment of dermatologic conditions(excluding eyes), such as psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is for the partial treatment and is intended to be used on intact skin only.

The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.

This document describes the 510(k) summary for the Boston Aesthetics INC 308nm UV Phototherapy System (UV-K; UV-X; UV-Y; UV-Z). Below is a summary of the acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (K172273 - 308nm Excimer System) and reference devices (K170489 - Clarify Phototherapy System, K191571 - UV Radiation Treatment System). The "acceptance criteria" are not explicitly listed with numerical thresholds in the provided document, but rather are implied by the demonstration that the subject device's characteristics are similar or comparable and that non-clinical performance testing meets established standards.

| Feature / Criteria (Implied) | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Subject Device K244022) | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of specific dermatologic conditions on intact skin, under prescription. (Predicate: psoriasis, vitiligo; Reference: adds atopic dermatitis, seborrheic dermatitis, leukoderma) | Intended for treatment of psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. Used on intact skin only. (Prescription use in hospitals, clinics, and households). | Similar & Comparable |
| Light Source | Xenon-Chlorine (XeCI) excimer lamp or LED UV lamps (Predicate: XeCI excimer lamp; Reference 1 & 2: LED UV lamps) | LED UV lamps | Same |
| UV Spectral Output | UVB (Predicate: UVB; Reference 1: UVB; Reference 2: UVA&UVB) | UVB | Same |
| UV Light Wavelength | 308nm±2nm (Predicate and Reference 2 UVB: 308nm±2nm or 300nm-320nm; Reference 1: 300nm-320nm) | 308nm±2nm | Same |
| Max Power Output | Comparable to predicate/reference devices (Predicate: 50mW/cm²; Reference 1: 3-15mW/cm²; Reference 2: 10mW/cm²) | UV-K&UV-X: 30 mW/cm²; UV-Y&UV-Z: 50 mW/cm² | Comparable |
| Maximum Treatment Dose | ≤ 5J/cm² (Predicate: 2J/cm²) | ≤ 5J/cm² | Comparable |
| Action Area | Partial treatment excluding eyes (Predicate and Reference 2: Partial treatment excluding eyes) | Partial treatment excluding eyes | Same |
| Treatment Area | Comparable to predicate/reference devices (Predicate: 16cm²; Reference 1: 4.5cm²; Reference 2: Max 15cm²) | 3cm² ~ 3.41cm² | Comparable |
| Treatment Time | Comparable to predicate/reference devices (Predicate: 140s; Reference 2: 520 min) | UV-K&UV-X: 1140s; UV-Y&UV-Z: 1100s | Comparable |
| User-Contacting Materials| Safe and biocompatible materials (Predicate: ABS; PC; Reference 1: ABS; Reference 2: ABS) | ABS; PC (demonstrated non-cytotoxic, non-irritating, non-sensitizing via ISO 10993-5, -10, -23) | Same |
| Safety and Performance | Compliance with recognized electrical safety, EMC, and photobiological safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471 generally common across predicates/references) | Compliance with: AAMI/IEC 60601-1:2005/(R)2012+A1+A2, ANSI AAMI IEC 60601-1-2: 2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 60601-2-83:2019, IEC 62471:2006. Biocompatibility testing per ISO 10993-5, -10, -23. Software documentation compliant with FDA guidance. | Same |

Study Proving Device Meets Acceptance Criteria:

The provided document describes a non-clinical performance testing approach to demonstrate substantial equivalence, rather than a clinical study with patient outcomes.

• Study Type: Non-clinical (bench testing, biocompatibility, and software documentation).
• Objective: To demonstrate that the 308nm UV Phototherapy System is as safe and effective as the predicate device (K172273) and reference devices by meeting recognized performance standards and having comparable technological characteristics.

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

This is not a clinical study involving a "test set" of patients or data in the typical sense for performance metrics like sensitivity/specificity. Instead, it relies on:

• Bench Test Samples: The device units themselves (UV-K, UV-X, UV-Y, UV-Z models) are the "samples" for electrical safety, EMC, and photobiological safety testing. The number of units tested is not specified but is assumed to be sufficient for compliance with the relevant standards.
• Biocompatibility Samples: Samples of the user-contacting materials (PC, ABS) were tested. The number of samples is not specified but is assumed to follow the requirements of ISO 10993 standards.
• Data Provenance: Not applicable in the context of clinical data. The data comes from internal testing and validation against international and national standards.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

This information is not applicable. The assessment is based on objective testing against predetermined engineering and safety standards, not on expert interpretations of clinical images or outcomes.

4. Adjudication Method for the Test Set

Not applicable, as this is objective non-clinical testing against standards.

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

Not applicable. This device is a phototherapy system, not an AI-assisted diagnostic tool where human reader performance would be a primary metric.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device for therapeutic use, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness in this context is:

• Compliance with Recognized Standards: Meeting the requirements of international and national standards for medical electrical equipment (IEC 60601 series), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
• Comparison to Predicate Device: Demonstrating that the subject device's technological characteristics and intended use are similar or comparable to a legally marketed predicate device cleared by the FDA, without raising new questions of safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. This is a hardware therapeutic device, not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema). It is to be used on intact skin only. Patients shall use it at home under the guidance of the physician.

UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and eczema. It is to be used on intact skin only. Patients shall use it at home under the quidance of the doctor.

Users can set UV irradiation dose through the controller, and confirm the light emission by pressing the start button. The controller will control the light emitting time of the set dose. The light emission will stop automatically after the UV irradiation dose reaches the set value.

The provided text is a 510(k) Summary for a UV Phototherapy Device. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It then lists several international standards (IEC and ISO) with which the device complies. However, it does not provide:

• A table of actual acceptance criteria (e.g., minimum efficacy rates, safety thresholds) for the device's clinical performance.
• The reported device performance against such criteria.
• Details about specific studies (clinical or non-clinical) that "prove" the device meets these criteria in terms of clinical outcomes for psoriasis, vitiligo, and atopic dermatitis.
• Information on sample sizes for test sets or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document focuses on substantiating equivalence to predicate devices primarily through technological comparison and compliance with electrical safety, EMC, and biocompatibility standards, rather than direct evidence of clinical efficacy meeting predefined acceptance criteria for the treatment of dermatologic conditions.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies and ground truth, as this information is not present in the provided text.

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The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.

The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02.

The device can be used in hospitals, clinics and households.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

Based on the provided text, the device is a "Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)". The submission is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to existing legally marketed devices, rather than seeking approval for a novel device.

In the context of 510(k) submissions, "acceptance criteria" for performance are typically demonstrated through non-clinical tests (e.g., adherence to recognized standards like IEC 60601-1) and comparisons to predicate devices, rather than through a traditional clinical study with defined performance metrics like sensitivity, specificity, or reader improvement. The goal is to show the new device performs as well as or similarly to the predicate, and does not raise new questions of safety or effectiveness.

Therefore, the information you're asking for, particularly concerning AI/imaging device-specific criteria (sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.), is not applicable to this specific device submission (a UV phototherapy lamp). This device is hardware that emits UV light for therapeutic purposes, not an AI or imaging diagnostic device.

The study proving the device meets the acceptance criteria is fundamentally a non-clinical engineering and comparison study against established standards and predicate devices.

Here's a breakdown of the information that is available in the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are primarily adherence to safety, performance, and biocompatibility standards, and demonstrating comparable technological characteristics to predicate devices.

Specific Requested Information (and why it's mostly N/A):

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

• N/A: No clinical test set data is provided or required for this type of submission. The "tests" are non-clinical engineering and bench validation against standards. The provenance for these would typically be the manufacturer's lab in China.

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)

• N/A: Not applicable as there is no test set in the clinical/diagnostic sense and no ground truth requiring expert adjudication. Acceptance is based on meeting technical specifications and safety standards.

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

• N/A: Not applicable. There is no test set for clinical performance that would require adjudication.

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

• N/A: This is a therapeutic device (UV lamp), not a diagnostic AI device. MRMC studies are completely irrelevant to its function or approval process.

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

• N/A: Not applicable. This is a hardware device; there is no algorithm or standalone performance in the sense of AI.

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

• N/A: Not applicable. The "ground truth" for this device's performance is adherence to established technical standards (e.g., wavelength output, intensity, safety checks) and demonstrating that its characteristics are substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

• N/A: Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• N/A: Not applicable. There is no training set.

In summary: The provided document is a 510(k) summary for a physical medical device (UV lamp). Its "acceptance criteria" revolve around demonstrating safety, adherence to international technical standards, and substantial equivalence to existing predicate devices based on non-clinical (bench) testing and comparative analysis of its specifications. The detailed clinical trial and AI/algorithm-specific metrics you've asked about are specific to a different class and type of medical device (e.g., diagnostic software or imaging AI) and are not presented or required for the approval of this UV phototherapy lamp.

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The UV Phototherapy is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.

The proposed device is a hand held ultraviolet phototherapy device, intended for partial treatment excluding eyes. Irradiation time can be adjusted from 0~30min and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in sixteen specifications. The device model KN-4003AL2S, KN-4003BL2S, KN-4003AL2DS, KN-4003BL2DS, KN-4006AL1S, KN-4006BL1S, KN-4006AL1DS and KN-4006BL1DS are designed with SD card. The recommended treatment can be written into the SD card by a physician. The device can be used in hospitals, clinics and households.

This document is a 510(k) Summary for a UV Phototherapy device (K181805) and describes non-clinical testing for substantial equivalence, not a clinical study to prove the device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted.

However, I can provide the following based on the provided text:

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

The document does not explicitly present acceptance criteria in a table format with corresponding device performance results in the typical sense of a clinical trial. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards". These standards implicitly act as the acceptance criteria for non-clinical aspects.

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

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no clinical test set, sample size, or data provenance to report in this context. The document focuses on non-clinical testing for compliance with international standards.

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, as no clinical study with a test set requiring expert ground truth was conducted or submitted.

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

Not applicable, as no clinical study with a test set requiring adjudication was conducted or submitted.

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 a phototherapy device, not an AI diagnostic tool, and no clinical comparative effectiveness study was conducted or submitted.

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

Not applicable. This is a phototherapy device, not an algorithm, and no clinical performance study was conducted or submitted.

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

For the non-clinical tests conducted, the "ground truth" is compliance with the specified international standards and established test methods for biocompatibility and electrical safety. For example, for cytotoxicity, the "ground truth" is the determination of whether cytotoxicity is present according to ISO 10993-5.

8. The sample size for the training set

Not applicable, as no clinical study was conducted. There is no mention of a training set as this is not an AI/algorithmic device requiring training data.

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

Not applicable, as no training set was used.

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The UV phototherapy, model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006, delivers ultraviolet (UV) light to targeted affected skin. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

The UV Radiation Treatment System model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006 delivers ultraviolet (UV) light to targeted affected skin, via Fluorescent UV lamps. It is a Stationary base unit with hand held therapy wand or hand held device.

The provided text does not contain information regarding an acceptance criteria table, device performance, and the study details requested. The document is a 510(k) summary for a UV phototherapy device (K132643) that focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and safety standards (IEC 60601-1 and IEC 60601-1-2) and biocompatibility.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document discusses:

• The device being a UV phototherapy system (model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006) intended for the treatment of psoriasis, vitiligo, and atopic dermatitis.
• Comparison to a predicate device (DermaPal) based on product code, regulation number, intended use, material, sterility, single use, energy source, safety standards, biocompatibility, mode of operation, and features.
• Confirmation from the FDA of substantial equivalence based on the provided information.

To fulfill the request, further documentation describing the device's validation and clinical studies would be required.

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