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Photon therapy apparatus 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±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (830±8mm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The photon therapy apparatus (BL-10) use 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±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm).

The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources.

The provided document is a 510(k) summary for the Xemis Medical Technology (Shenzhen) Co., Ltd. "Photon Therapy Apparatus (BL-10)". It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria and detailed study results as would be typically found for a study proving a device meets acceptance criteria, especially in the context of an AI/ML-driven device's performance. The provided text primarily focuses on the device's technical specifications and a comparison to predicate devices, stating that "Non-clinical tests" were performed for electrical safety, EMC, performance, and software verification/validation. It explicitly states "Clinical study: Not applicable."

Therefore, based on the provided text, I cannot fulfill most of your requested information as it pertains to clinical performance studies, acceptance criteria, test set details (sample size, data provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance, and training set details for an AI/ML device.

The document describes a photon therapy apparatus, which is a physical device emitting light for dermatological conditions, not an AI/ML-driven medical device that would involve a test set, ground truth interpretation by experts, or MRMC studies.

If this was a request for information on an AI/ML device, the provided text would be a "reject" or "missing information" response. As it is not an AI/ML device, the traditional performance acceptance criteria for a medical device of this type would typically involve measurements of parameters like wavelength, power output, irradiance, and safety adherence to relevant electrical and photobiological safety standards, which are mentioned generally.

Here's what I can extract from the document regarding "acceptance criteria" in a general sense, and "study" information as provided:

1. Table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of acceptance criteria with corresponding performance results in a standalone "acceptance criteria" section. Instead, the basis for "acceptance" (or rather, substantial equivalence for FDA clearance) is demonstrated through comparison of the proposed device's specifications and performance to predicate devices. The "performance" here refers to meeting technical specifications and safety standards, rather than clinical efficacy outcome measures from a trial.

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

• Not applicable. This document describes a physical medical device (photon therapy apparatus), not an AI/ML diagnostic or prognostic algorithm that would have a "test set" of patient data. The "tests" mentioned are non-clinical (electrical safety, EMC, performance, software V&V).

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 above, no clinical "test set" and thus no ground truth established by experts is described for this type of device submission.

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

• Not applicable. No clinical "test set" and thus no adjudication method is mentioned.

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, so no MRMC study was performed. The document explicitly states "Clinical study: Not applicable."

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 concensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for this device's performance would be the physical measurements of its light output and adherence to electrical safety standards, not clinical ground truth from patient data.

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

In summary, the provided document is a 510(k) notification for a photon therapy device, focusing on demonstrating substantial equivalence to predicate devices based on technical specifications and non-clinical safety/performance testing. It does not involve AI/ML components or clinical performance studies typically associated with the detailed criteria you've outlined.

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Red light: Treatment of full-face wrinkles.

Blue light: Treatment of mild to moderate inflammatory acne.

Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne.

LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps.

There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).

The provided text is a 510(k) Summary for a medical device (LED light therapy mask) seeking clearance from the U.S. FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a specific study conducted for this device.

Instead, the document primarily compares the subject device to several predicate devices across various characteristics and lists non-clinical tests conducted to ensure safety and compliance with relevant standards. It explicitly states, "Clinical data: Not applicable."

Here's a breakdown of what can be extracted or inferred based on your request, and what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to recognized standards, not on presenting specific performance criteria and results of a dedicated study for the current device.

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

This information is not available. The document explicitly states "Clinical data: Not applicable," meaning no clinical test set was used for this 510(k) submission to demonstrate the device's efficacy.

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):

This information is not applicable/not provided. Since no clinical test set with human assessments or ground truth establishment relevant to efficacy is mentioned, there are no experts establishing ground truth in this context. The document focuses on regulatory compliance and technical equivalence.

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

This information is not applicable/not provided. Without a clinical test set requiring adjudication, this detail is irrelevant to this submission.

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:

This information is not applicable/not provided. The device is an LED light therapy mask, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable/not provided. This is a physical device (LED light therapy mask), not an algorithm or software-only device. Therefore, a standalone algorithm performance study is not relevant.

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

This information is not applicable/not provided. Since no clinical efficacy study or test set for the device's indications is presented, there is no discussion of the type of ground truth used to validate its performance for those indications. The "ground truth" in this context is the performance and safety established for the predicate devices and the compliance to international safety standards.

8. The sample size for the training set:

This information is not applicable/not provided. As "Clinical data: Not applicable" is stated, there is no mention of a training set for an algorithm.

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

This information is not applicable/not provided. No training set for an algorithm is mentioned.

Summary of available information related to the device's 'proof' and acceptance:

The 'proof' for the LED light therapy mask meeting the criteria for market clearance (not specific acceptance criteria against a clinical study) relies on demonstrating substantial equivalence (SE) to legally marketed predicate devices and compliance with recognized non-clinical safety standards.

Non-clinical tests performed (supporting safe operation, not efficacy for treatment claims):

• Electrical safety: ANSI AAMI ES 60601-1
• Electromagnetic compatibility: IEC 60601-1-2
• Home healthcare environment requirements: IEC 60601-1-11
• Safety of non-laser light source equipment: IEC 60601-2-57
• Biocompatibility:
  • ISO 10993-5 (In Vitro Cytotoxicity)
  • ISO 10993-10 (Irritation and Skin Sensitization)
• Software verification and validation testing: Conducted as per FDA's guidance for software in medical devices.

Conclusion stated in the document:

"The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LED light therapy mask should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject device (LED light therapy mask) is Substantial Equivalent to the predicate devices K200983, K221151, K162489 and K212155."

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