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308nm Excimer Phototherapy Device is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

Ultraviolet phototherapy originated in the 1920s. Due to the development of science and technology, the technology of artificial light source has developed rapidly. UVB therapy, as a representative, has become one of the effective methods to treat various skin diseases in developed countries such as Europe and America.

The provided text is a 510(k) summary for the Xuzhou Kernel Medical Equipment Co., Ltd.'s 308nm Excimer Phototherapy Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, many of the requested data points (sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test and training sets, training set size, how training ground truth was established) are not available in this document because they are typically associated with performance evaluations of AI/diagnostic software devices, which this phototherapy device is not.

The document discusses non-clinical tests to establish the device's safety and performance equivalence to a predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of specific sensitivity, specificity, or similar performance metrics for a diagnostic device. Instead, it demonstrates equivalence through adherence to international standards and direct comparison of technical specifications with a legally marketed predicate device.

The "acceptance criteria" here are implied by compliance with the listed standards and demonstrating that the device's technical specifications and intended use are "substantially equivalent" to the predicate device.

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

Not applicable. This is a phototherapy device, not a diagnostic or AI software device evaluated with a patient test set. The document refers to "non-clinical tests" and "equipment performance testing."

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. No ground truth was established by experts for a test set in the context of this device.

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

Not applicable.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm.

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

Not applicable. The "ground truth" for this device's performance involved adherence to technical standards and verifying physical properties (e.g., wavelength, UV intensity, temperature) and safety against established international benchmarks.

8. The sample size for the training set

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

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

Not applicable.

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LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The red light (633±10mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain. arthritis and musele spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The LED Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10mm), yellow light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm).

The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light).

The instrument is mainly composed of a main frame, an irradiator, and a lifting stand.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA regarding an LED Light Therapy Device (KN-7000L). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through comparison of technical specifications and non-clinical testing.

Therefore, the document does NOT contain information regarding clinical studies, acceptance criteria for an AI/device performance, expert ground truth establishment, or multi-reader multi-case studies. The device in question is an LED light therapy device, not an AI-powered diagnostic or assistive device that would typically undergo such rigorous performance evaluation against patient data.

The document details the device's technical specifications and confirms compliance with electrical safety, electromagnetic compatibility, and photobiological safety standards.

As a result, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No performance metrics beyond technical specifications (wavelength, irradiance, etc.) and compliance with safety standards are mentioned.
2. Sample sizes used for the test set and the data provenance: No clinical test sets or data provenance (country, retrospective/prospective) are discussed. The "test set" here refers to non-clinical tests (e.g., electrical, photobiological).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no ground truth established for clinical performance.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study was conducted or mentioned. This type of study is typical for AI devices assisting human readers in diagnostic tasks, which is not the function of this LED light therapy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

However, I can extract the following information that is relevant to the type of acceptance criteria and "study" conducted for this device, which focuses on non-clinical performance and substantial equivalence:

1. Table of "Acceptance Criteria" (Non-Clinical Performance) and Reported Device Performance

For this type of device, "acceptance criteria" primarily relate to meeting established safety and performance standards rather than clinical efficacy metrics derived from patient data. The manufacturer asserts substantial equivalence based on these comparisons and non-clinical testing.

Summary of "Study" Proving Compliance:

The "study" in this context is a non-clinical testing and comparison study aiming to demonstrate substantial equivalence (SE) to predicate devices by verifying the new device shares fundamental technological characteristics and performs comparably in terms of safety and technical specifications.

• Type of "Study": Non-clinical performance testing and comparative analysis to predicate devices.
• Purpose: To demonstrate substantial equivalence (SE) for 510(k) clearance, indicating the device is as safe and effective as a legally marketed predicate device.
• Ground Truth: The "ground truth" for this regulatory submission is adherence to recognized medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471) and the established performance characteristics of the predicate devices. The device's measured technical specifications (e.g., wavelength, irradiance, power) were compared against these standards and predicate parameters.
• Data Provenance/Sample Size: Not applicable in the traditional sense of patient data. The "sample size" refers to the tested units of the KN-7000L device undergoing the specified non-clinical tests. The data provenance is from the manufacturer's internal testing. The document does not specify the exact number of units tested, but it is implied that the testing performed on the device samples confirmed compliance.
• Expert involvement for Ground Truth, Adjudication, MRMC, Standalone AI, Training Set: These concepts are not applicable to the non-clinical testing and substantial equivalence demonstration for a light therapy device. There is no AI component, and no human diagnostic performance is being evaluated.

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The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

The proposed device, 308nm Excimer System is a new type of ultraviolet light therapy instrument, which could emit high levels of UV light. It has the following features:

• High intensity UV light.
• The instrument is suitable for small area treatment with good targeting.
• 8 inches Super Large color touch LCD screen which make the operation display more convenient;
• Manual MED tests can also be performed according to the skin characteristics of the patient.
• One-click Control light source Output.
• Powerful user management capabilities.
• Can realize the export and view of user information;
• Multi-spec treatment handle light filter. The user can choose filter according to the size of the treatment area. Avoid excess radiation output.
• Fingerprint entry makes it easy for doctors to quickly access patient information (for KN-5000D):
• Accurate calibration system. Enhanced reliability of instrument dose output (KN-5000D applicable).

Here's a breakdown of the acceptance criteria and study information for the 308nm Excimer System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as one might expect for an AI/diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" being evaluated is the device's adherence to these standards and its operational characteristics being comparable to legally marketed devices.

Note on "Analysis 1, 2, 3, 4" from the document: These sections discuss slight differences in specifications like Max Power Output, Treatment Area, Treatment Time, Maximum Dose, Power Source, MED Dose Determination, and Operating/Storage Environment. The conclusion for each is that these differences fall within the range of predicate devices or comply with relevant standards, and therefore do not raise any safety or effectiveness issues, thus meeting the implicit acceptance criteria of being substantially equivalent.

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

• No clinical test set was used for this submission. The document explicitly states: "No clinical study is included in this submission."
• The device's substantial equivalence was determined based on non-clinical (lab bench) testing and comparison to predicate devices' specifications and compliance with international standards.

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

• Not applicable. As no clinical studies were performed and the evaluation relied on non-clinical testing and comparison to predicate devices, there was no ground truth for a test set established by experts in the context of diagnostic performance.

4. Adjudication method for the test set:

• Not applicable. No clinical test set.

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 device is a medical equipment (ultraviolet lamp) for treatment, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is a medical device, not an algorithm. Its performance is evaluated based on its physical and operational specifications and compliance with safety standards, not an algorithm's output.

7. The type of ground truth used:

• For non-clinical tests: The "ground truth" implicitly refers to the specified values, ranges, and requirements outlined in the international standards (e.g., IEC 60601-1, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, ISO 10993-5, ISO 10993-10) that the device was tested against. Compliance with these standards served as the "truth" for safety and basic performance characteristics.
• For substantial equivalence: The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices, which the proposed device aims to demonstrate equivalence to based on technological characteristics and compliance with standards.

8. The sample size for the training set:

• Not applicable. This device is a physical medical equipment, not an AI model that requires a training set.

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

• Not applicable. No training set was used.

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The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.

The Hair Growth System (Model: KN-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished.

The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A.

For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.

This document is a 510(k) premarket notification for a medical device called "Hair Growth System" (Models: KN-8000B/KN-8000C/KN-8000D/KN-8000E). It seeks to demonstrate substantial equivalence to previously cleared devices.

The information provided does not include details about specific acceptance criteria, reported device performance measurements, sample sizes, ground truth establishment, or clinical study designs in the way typically expected for a detailed AI device study. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" is implicitly demonstrated through adherence to these standards and similarity to already-cleared devices.

The tables provided (pages 6-7) are comparison tables showing technical characteristics of the subject device against predicate devices, with "Verdict" indicating if they are substantially equivalent (SE) or have minor differences. These are not performance metrics in the typical sense for AI, but rather technical specifications.

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

The document explicitly states: "Clinical performance is not deemed necessary." (Page 10)

Therefore, there was no clinical test set with a specific sample size, nor information on data provenance for such a set. The submission focuses on non-clinical testing and substantial equivalence.

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

Since no clinical test set was used, there were no experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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 device is a standalone hardware device (infrared lamp/laser for hair growth), not an AI-powered diagnostic or assistive tool that would involve human readers or MRMC studies.

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

This refers to a standalone hardware device, not a software algorithm. Its "standalone performance" is assessed through compliance with electrical safety, EMC, biocompatibility, usability, and software verification standards. The comparison tables illustrate that its technical specifications (wavelength, output, number of diodes/LEDs) are within ranges or similar to those of its predicate devices, which have already been deemed safe and effective.

7. The Type of Ground Truth Used

Given that "Clinical performance is not deemed necessary," there was no "ground truth" in the sense of expert consensus, pathology, or outcomes data from a clinical trial for the subject device to evaluate its effectiveness. The ground truth for its safety and function is established by compliance with engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993) and the demonstrated substantial equivalence to predicate devices, which were presumably cleared based on their own safety and effectiveness data (either clinical or through substantial equivalence to even earlier devices).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set.

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

Not applicable.

Summary of Device Evaluation in the Document:

The "Hair Growth System" was evaluated through:

• Lab bench testing for:
  • Electrical safety and performance (IEC 60601-1, IEC 60825-1, IEC 62471, IEC 60601-2-57)
  • Electromagnetic compatibility (IEC 60601-1-2)
  • Biocompatibility (ISO 10993-5, ISO 10993-10) for patient-contacting materials
  • Usability (IEC 62366)
  • Software verification and validation (FDA guidance for software in medical devices)
• Comparison to predicate devices (DermaScalp Laser Cap, Capillus devices, iRestore Hair Growth System, iRestore Professional 282) to establish substantial equivalence in terms of:
  • Intended Use
  • Device Type (LLLT)
  • Prescription status (OTC)
  • Waveform and Wavelength (655nm ±5nm, 655nm ±20nm for LED)
  • Amounts of laser diodes/LEDs
  • Laser radiation output (

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The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Growth System Model: KN-8000A is a transportable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. It produces a red light, diode lasers operating at a 650-nanometer wavelength (maximum output power of each is 5 mW). The device mainly includes a host machine, light source and lifting bracket. The light source applicator was equipped with the access sensor device, it can power off the light source when the patient's scalp deviates from the work area.

The provided text is a 510(k) summary for the "Hair Growth System (Model: KN-8000A)" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for an AI/algorithm-driven device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for an AI model.

The "Test Summary" section in the document only mentions:

• Electrical safety test (IEC 60601-1 and IEC 60825-1 standards)
• Electromagnetic compatibility test (IEC 60601-1-2 standard)
• Software verification and validation test (according to FDA guidance for software in medical devices)

These tests are related to the safety and fundamental performance of the device's hardware and software, but not to the clinical effectiveness or performance of an AI component in achieving a specific outcome (like hair growth based on algorithmic assessment). The device itself is described as a "low-level laser device" not explicitly an AI-driven system.

In summary, none of the requested information regarding AI/algorithm acceptance criteria and study details is present in the provided text. The document's purpose is to establish substantial equivalence for a physical device, not to describe the validation of an AI algorithm.

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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 Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.

The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Colposcope System has two kinds of colposcopes, a video colposcope and a binocular colposcope.

The video colposcope system is a non-patient contacting image capture device (CCD color camera) with a digital magnification of up to x16, working distance supporting 200mm, and a green filtered light source mounted on a vertical stand, swing arm stand or trolley. Tissue is magnified and viewed directly via the LCD screen attached to the capture device or on the commercially available color monitor. The video colposcope system has four models, including KN-2200A, KN-22001 and KN-2200I(H).

The binocular colposcope system is designed based on an optical colposcope. Its imaging system consists of optical imaging and CCD imaging. It permits viewing of the vagina, cervix and external genitalia by a telescopic system and the CCD camera captures digital images. The binocular colposcope system has two models, including KN-2200B and KN-2200BI. The two models have the same binoculars, CCD camera, cables except for the light source size and the stand type.

Both video colposcope system and binocular colposcope come with image management software, which is provided on a CD-ROM. The image management software allows the viewer to view, compare, record and print the image by series peripheral units, such as computer, monitor and printer.

The provided document is a 510(k) Summary for the Xuzhou Kernel Medical Equipment Co., Ltd. Colposcope System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner an AI device might.

Therefore, the information required to fully answer the request, particularly regarding specific performance metrics (like sensitivity, specificity, accuracy), sample sizes for test and training sets, expert qualifications, ground truth establishment for a diagnostic AI, or MRMC studies, is not present in this document.

However, I can extract the available information related to non-clinical tests and performance specifications that are analogous to acceptance criteria in this context.

Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests and Specifications)

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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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