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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 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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