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Blue (415-425mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Red (630-640nm) and Infrared (820-830mm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The Photo-Therapy Device SMARTLUX MINI is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).

The device produces light in the following regions of the light spectrum:

• · Red (630-640nm)
• · Blue (415-425nm)
• · Yellow (585-595nm)
• Infra-red (820-830nm)

This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.

The provided text is a 510(k) summary for the Smartlux Mini device, which is a phototherapy unit. It details the device's characteristics and its substantial equivalence to a predicate device (Soli-Lite LG4 Galileo). However, it does not contain information about clinical studies with acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader studies.

The document primarily focuses on:

• Non-Clinical Testing: Conformance to electrical safety, electromagnetic compatibility, and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471).
• Software Validation: The software was designed, developed, verified, and validated according to a software development process, and is considered a "MODERATE level of concern software."
• Technological Equivalence: Comparison of wavelengths, irradiance, and operation modes to a predicate device (K192755).

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical efficacy or diagnostic performance, nor can I answer questions about sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies, as this information is not present in the provided document.

The document states that "Testing of key performance characteristics demonstrates that the subject device can be used safely and effectively for the proposed indications for use," but it does not elaborate on what these "key performance characteristics" are in terms of clinical outcomes or how effectiveness was quantitatively demonstrated by such testing, beyond the non-clinical testing listed.

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633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions

415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris

830nm wave length : the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

SMARTLUX is light therapy system using two kinds of wave length light and infrared ray. It has four type of head which is including red, blue and IR respectively. Heads are chanqeable by user and assembled head is identified automatically after changing head and user interface is also changed according to each head. For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software.

The provided text describes a 510(k) summary for a medical device called SMARTLUX, which is a light therapy system. However, the document does not contain information about "acceptance criteria," "reported device performance" in a quantitative sense, "sample sizes" for test sets or training sets, "data provenance," "number of experts" for ground truth, "adjudication methods," "MRMC comparative effectiveness studies," or "standalone performance." The performance testing mentioned is generic (e.g., "Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment" and "Performance Test Report for Temperature of therapeutic heat"). This suggests that the device's performance was evaluated against safety and general standards for medical electrical equipment and therapeutic heat, rather than clinical efficacy or diagnostic accuracy, which would typically involve the detailed criteria requested in your prompt.

Therefore,Based on the provided 510(k) summary (K120460) for the SMARTLUX device, I cannot fill out the requested information for acceptance criteria and a study proving device meets acceptance criteria. The document focuses on regulatory submission details, device description, intended use, and predicate devices, rather than a clinical performance study with the specific metrics you've requested.

Here's why and what information is available:

• Type of Device: The SMARTLUX is a light therapy system, and its predicate devices are also light therapy systems (Omnilux Revive, Omnilux Blue, Omnilux Plus). These are generally cleared based on substantial equivalence to existing devices for specific therapeutic indications (e.g., dermatology, acne treatment, pain relief) and compliance with safety standards, rather than an AI-driven diagnostic or image analysis device that would typically involve the comprehensive performance metrics you've outlined.

Information NOT Found in the Document:

1. Table of acceptance criteria and reported device performance: This document does not specify quantitative clinical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance against such criteria.
2. Sample size used for the test set and data provenance: No information on a test set (clinical or otherwise for performance evaluation) is provided, nor its sample size or data origin.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no mention of a test set requiring expert-established ground truth.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No mention of an MRMC study or any AI component that would be compared to human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a therapeutic light system, not an AI algorithm.
7. The type of ground truth used: Not discussed, as no performance study requiring ground truth is detailed.
8. The sample size for the training set: Not applicable, as this is not an AI learning system.
9. How the ground truth for the training set was established: Not applicable.

What is mentioned regarding "Performance Test":

The document states:

• "Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment."
• "Performance Test Report for Temperature of therapeutic heat The test data is attached." (However, the "attached" data is not present in the provided text).

This indicates that the "performance tests" were related to safety and electrical standards conformance (EN 60601-2-22) and potentially thermal output/safety ("Temperature of therapeutic heat"), which are critical for light therapy devices but do not equate to clinical efficacy or diagnostic accuracy studies typically involving the metrics you requested. The acceptance criteria for these would be compliance with the specified standards and acceptable temperature ranges, respectively.

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