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The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,

The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.

The mask is worn on the face and is held in place by head straps , The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The HIGHERDOSE Red And Infrared Light Mask cannot be operated while charging.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided document is a 510(k) premarket notification for a medical device (HIGHERDOSE Red and Infrared Light Mask). It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study for novel performance claims.

Therefore, the information required to fully answer your request regarding acceptance criteria and performance studies for an AI/software-based device, particularly those concerning human-in-the-loop performance, expert ground truth, and training data provenance, is not present in this document.

However, I can extract the information provided about the non-clinical performance testing of this light therapy mask, which is a hardware device with some embedded software for control (e.g., timer).

Here's a breakdown of what can be inferred and what is explicitly stated:

Device: HIGHERDOSE Red and Infrared Light Mask (MK66-L)

Indications for Use: The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

Non-Clinical Performance Testing (Hardware and Embedded Software)

The document lists several non-clinical performance tests conducted, relevant to the safety and fundamental operation of the device, rather than its clinical efficacy in treating wrinkles which is established by substantial equivalence to predicates.

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

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

• Sample Size: "The test sample is the final, finished product." For each test, it implies at least one production unit was tested. The specific number of units is not stated, but typically for these types of tests, a small representative sample or even a single unit is sufficient to demonstrate compliance with standards.
• Data Provenance: Not specified, but generally, these tests are conducted by accredited labs. The manufacturer is based in Shenzhen, Guangdong, China. These are typically lab bench tests, not involving human subjects or real-world data collection in the sense of a clinical trial.

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 and not provided. These are engineering/safety/performance tests against established international standards, not diagnostic device studies requiring medical expert ground truth.

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

• Not applicable. These are objective engineering tests with pass/fail criteria based on standards.

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

• No MRMC or comparative effectiveness study was conducted or reported. This device is a direct-to-consumer light therapy mask, not an AI-assisted diagnostic tool.

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

• Not applicable in the context of an AI algorithm. The device has embedded software for basic control (like a timer), and "Software verification and validation testing" was conducted for this embedded software, considered a "moderate" level concern. However, this is not a standalone AI algorithm being evaluated for diagnostic or interpretive performance.

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

• For the non-clinical tests, the "ground truth" is adherence to the specified international safety and performance standards (e.g., IEC 60601-1, IEC 62471), determined through objective measurements and validated test methodologies.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a "training set." The embedded software is deterministic and not trained on data.

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

• Not applicable, as there is no training set mentioned for this product.

Summary regarding AI/Software-based device criteria:

The provided document is not for a device that fits the typical "AI/software-based device" criteria you've outlined (e.g., requiring MRMC studies, expert ground truth for image interpretation, or large training datasets). This 510(k) is for a hardware device (a light therapy mask) with embedded software for basic functionality (like a timer). The review focuses on demonstrating safety, fundamental performance, and substantial equivalence to existing predicate devices based on non-clinical engineering and safety standards. No clinical efficacy study data is presented, as it was deemed "not needed for this 510(k)" due to the substantial equivalence pathway.

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