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The Ultraviolet Phototherapy Device is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

Ultraviolet Phototherapy Device

This FDA 510(k) clearance letter is for a physical device, an Ultraviolet Phototherapy Device, and not for an AI/software as a medical device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• Any study proving AI model performance.
• Data provenance, sample sizes, expert qualifications, or adjudication methods for an AI test set.
• Multi-Reader Multi-Case (MRMC) studies for AI.
• Standalone AI performance.
• Training set details for an AI model.

The clearance is based on substantial equivalence to existing predicate devices, which primarily relies on technological characteristics, indications for use, and safety/performance data typical for physical medical devices (e.g., electrical safety, EMC, photobiological safety, performance of the UV light output).

In summary, none of the requested information regarding acceptance criteria and studies for an AI/SaMD can be extracted from this document, as it pertains to a traditional physical medical device.

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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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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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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 DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.

This is a 510(k) premarket notification for a phototherapy device, not an AI/ML device, therefore, many of the typical acceptance criteria and study attributes for AI/ML performance evaluation are not applicable. The device is a "DT Controlled Phototherapy Equipment" which is a modernization of a previous controller for phototherapy devices. The change is primarily to the controller unit's hardware and software (UI, processor, prescription entry method).

Here's an analysis based on the provided document:

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

The document does not specify quantitative acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on the device performing as expected for a phototherapy controller and maintaining substantial equivalence to its predicates.

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

Not applicable for this type of device. The "test set" here refers to the functional testing of the controller, not a data set of patient cases or images. The testing would involve a rigorous set of test cases designed to exercise all functionalities of the controller. The document indicates "Functional testing in the form of Black Box testing."

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

Not applicable for this type of device. "Ground truth" for this device relates to whether the controller correctly performs its functions (e.g., sets time, turns on/off, displays correctly). This is typically verified by engineers and quality assurance personnel against design specifications, not clinical experts establishing medical ground truth.

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

Not applicable for this type of device. Functional verification and validation do not typically involve adjudication methods like those used for clinical image interpretation. Performance is assessed against predefined specifications.

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 phototherapy unit controller and does not involve AI or human "readers" interpreting medical data.

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

Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electronic device controller.

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

The "ground truth" for this device's performance is its conformance to engineering specifications and regulatory standards (e.g., electrical safety, EMC, software validation). Functional tests ensure the device operates as designed and intended.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set" in the context of machine learning.

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

Not applicable.

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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 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The 3 Series NeoLux device is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The 3 Series NeoLux device delivers a 360-degree full body treatment, with spectral output from UV through visible, through an array of 24-48 fluorescent lamps (Either F72 or F79 length). Treatments are controlled through the Smart Touch Controller Software interface, Flex Controller or ClearLink Controller interface. The Smart Touch Software interface is installed remotely on a custom-built computer. An "off the shelf" replacement is not possible. Replacement can only be obtained through Daavlin. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Furthermore, the physician can restrict the amount and type of access that is granted to each authorized operator. Each authorized operator is assigned an initial default pin number. The system requires each operator to select a new individual pin and change the default pin upon initial logon. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. The Smart Touch equipped computer will interface with the 3 Series NeoLux device through a closed wired Ethernet connection and a Daavlin Distributing Company UV4001. While the Flex Controller is controlled by an integrated digital timer with an LCD segmented display and four membrane buttons as the interface, and ClearLink Controller is controlled by a microprocessor controlled with an LCD touch screen display. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light.

This document is a 510(k) summary for the Daavlin 3 Series NeoLux phototherapy equipment, seeking clearance from the FDA. It details the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided information, the 3 Series NeoLux device is a phototherapy equipment indicated for treating diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. This is not an AI/ML powered device, therefore the request for information on acceptance criteria and a study that proves the device meets the acceptance criteria is not applicable in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.

Here's an analysis of the provided information, structured as requested, with "N/A" for sections not applicable to this type of device or not explicitly mentioned in the provided text:

Acceptance Criteria and Device Performance Study for 3 Series NeoLux (Non-AI/ML Device)

The 3 Series NeoLux is a phototherapy device, not an AI/ML powered medical device. Therefore, the concept of "acceptance criteria" and "device performance" in the context of metrics like sensitivity, specificity, or image analysis accuracy typically associated with AI/ML studies is not applicable here.

Instead, the device's "performance" is demonstrated through its fulfillment of its intended use (delivering specific light spectrums for dermatologic treatment) and its substantial equivalence to previously cleared predicate devices. The "study" mentioned for phototherapy devices typically involves engineering and safety testing to ensure the device operates as intended and meets relevant safety standards (e.g., electrical safety, electromagnetic compatibility, radiation emission controls).

1. Table of Acceptance Criteria and Reported Device Performance

Note: For non-AI/ML devices like this phototherapy unit, the "acceptance criteria" are generally derived from recognized standards, predicate device characteristics, and safety/performance specifications rather than diagnostic performance metrics. The "reported device performance" is descriptive of its features and operational parameters, demonstrating its equivalence to predicate devices.

Proof of Meeting Acceptance Criteria:

The "study" demonstrating the device meets these criteria is the submission of technical documentation to the FDA as part of the 510(k) process. This typically includes:

• Engineering drawings and specifications.
• Risk analysis.
• Verification and validation testing results (e.g., electrical safety according to IEC 60601, electromagnetic compatibility (EMC), photobiological safety, power output measurements, controller function tests).
• Materials compatibility and biocompatibility if applicable.
• Software validation if software is involved in safety-critical functions (which it appears to be for the Smart Touch Controller).

The 510(k) summary explicitly states: "The 3 Series NeoLux device performance data is the same as or very similar to that of the claimed predicate devices. The lamps and construction used in the production of the predicate devices and the 3 Series NeoLux are the same. The devices materials, construction, treatment modality, patient safety, etc., is exactly the same or similar." This statement, backed by the detailed comparison table, is the core of how the device demonstrates it meets the "acceptance criteria" by being substantially equivalent to already cleared devices.

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

• Sample Size for Test Set: N/A. This is not an AI/ML device that uses a "test set" in the context of machine learning model evaluation. The "testing" involves engineering and functional validation of the physical device.
• Data Provenance: N/A. This information is not relevant for a phototherapy device's 510(k) clearance in the way it would be for an AI/ML diagnostic or prognostic tool.

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

• Number of Experts: N/A. Ground truth establishment is not relevant for this type of device clearance. The device treats conditions diagnosed by a physician, but the device itself does not make a diagnosis or prediction that requires "ground truth" to evaluate its performance.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. Not relevant for this type of device clearance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is not an AI/ML diagnostic or interpretive device, so an MRMC study is not applicable.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: N/A. As this is not an AI-assisted device, this metric is irrelevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: No. This device does not have an "algorithm" in the context of AI/ML; it is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: N/A. Not relevant for this type of device clearance.

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A. This is not an AI/ML device that uses a "training set."

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

• Ground Truth for Training Set: N/A.

Summary Conclusion:

The Daavlin 3 Series NeoLux phototherapy device obtained 510(k) clearance (K230382) by demonstrating substantial equivalence to its predicate devices (3 Series Phototherapy Unit K153749 and M Series Phototherapy Equipment K210881). The "acceptance criteria" and "performance study" for such a device primarily revolve around its technical specifications, safety, and functionality matching or being very similar to the predicate devices, ensuring it is as safe and effective. The provided document details these similarities across various features like intended use, patient population, technical characteristics (number of lamps, spectral output, power output, materials), and operational environment. It does not involve AI/ML performance metrics or studies.

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The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area.

The device is comprised of four main components:

• A base station
• A touchscreen where the user can enter system commands
• Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece.
• A printer accessory that can print out verification of treatment parameters for hard copy records.

The document describes the acceptance criteria and study for the Enhanced AURORA™ Medical Diode system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a 'test set' in the context of clinical data or patient samples. The performance data is based on bench testing only. Therefore, there is no sample size for a test set of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).

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

Not applicable. The performance data is derived from bench testing of the device's output, not from expert interpretation of medical images or patient data requiring ground truth establishment by experts.

4. Adjudication method for the test set

Not applicable, as a test set requiring adjudication by experts (e.g., for diagnostic accuracy) was not conducted. The assessment was based on physical measurements during bench testing.

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 phototherapy system, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Not applicable. This device is a medical phototherapy system, not an algorithm. Its performance is assessed by its physical output characteristics during bench testing, not by an algorithm's standalone performance.

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

The "ground truth" for this device's performance was the user-selected power settings, against which the actual UVA and UVB energy dosage output was measured. This is a technical performance measurement, not a clinical ground truth.

8. The sample size for the training set

Not applicable. This document describes a medical device for phototherapy, not a machine learning model requiring a training set.

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

Not applicable, for the same reason as above.

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The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.

Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical structure equipped with artificial light sources using ultraviolet light technology, which produces ultraviolet radiation within the UVA and UVB ranges. The UV light is intended to induce skin tanning. The user stands within the unit.

This document is a 510(k) Premarket Notification from the FDA for a tanning booth device. It outlines the device's classification, indications for use, and a comparison to a predicate device.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of typical medical device performance evaluation (e.g., diagnostic accuracy, clinical efficacy). Instead, it focuses on the substantial equivalence of an "i8 Tanning Booth" to a predicate device, primarily based on:

• Technological characteristics: Number of lamps, wattage, maximum exposure time.
• Non-clinical performance data: Electrical and mechanical safety testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), and software development (IEC 62304).

These are engineering and safety standards, not clinical performance metrics or studies involving patient data/diagnoses that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human reader improvement.

Therefore, I cannot provide the requested information from the given text as it does not exist within the document for this specific device.

If this were a typical AI/ML medical device submission document, it would include sections detailing clinical study design, performance metrics, and results. This document is for a Class II medical device product code LEJ (Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products), which generally follows a different regulatory pathway focused on safety and functional equivalence rather than clinical diagnostic performance.

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