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The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the device onto the face. This light is generated by VCSEL (Vertical-cavity surface-emitting laser) with two different spectrum wavelengths: red (660nm) and infrared (850nm).

Model JM1 is controlled directly by the button on the main mask body, which can realize device's power on/off and mode switch. The device will automatically shut down when the treatment time is over or when the pure water is run out.

Model JM2B is controlled by a controller that is connect to the main unit and the device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over. Both models are powered by rechargeable Li-battery.

The provided FDA 510(k) clearance letter and summary for the Wrinkle Treatment Device (JM1, JM2B) lack detailed information regarding specific acceptance criteria and the comprehensive study results (particularly clinical performance) that would typically prove a device meets those criteria. The submission focuses heavily on non-clinical performance data and substantial equivalence to a predicate device based on similar technological characteristics.

Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert adudication, MRMC studies, ground truth establishment), and specific performance metrics are not available in the provided text.

However, I can extract and infer some information based on the typical requirements for a 510(k) submission, especially for a device claiming substantial equivalence to a previously cleared device.

Here's an attempt to describe the acceptance criteria and the study that proves the device meets them, based on the provided document and general FDA 510(k) principles:

Acceptance Criteria and Device Performance (Inferred/General)

Since this is an OTC device intended for treating full-face wrinkles, the acceptance criteria would primarily relate to its safety and efficacy for that stated indication. As per the document, the device (JM1, JM2B) is deemed substantially equivalent to its predicate (JM2), implying that its performance is comparable and acceptable.

Given the nature of the device (light-based for wrinkle treatment), typical acceptance criteria in a clinical study would involve demonstrating a statistically significant reduction in wrinkles or improvement in skin appearance as assessed by objective measures (e.g., standardized photography, wrinkle grading scales) and/or subjective measures (e.g., patient satisfaction, expert assessment). Safety criteria would include the absence of serious adverse events and a low incidence of expected, mild side effects.

Table of Acceptance Criteria and Reported Device Performance

Self-correction: The provided document does not contain a table of explicit acceptance criteria or a detailed report of clinical performance metrics against such criteria. The "Performance Data" section lists non-clinical tests.

However, inferring from the "Substantial Equivalence" claim, the underlying acceptance criteria are that the device is "as safe and as effective as the legally marketed predicate device [K240360 (JM2)] for its intended use".

Study Details (Based on the provided document, many details are not explicit and would typically be found in the full 510(k) submission, not just the summary letter):

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for any clinical performance testing. The document focuses on non-clinical bench and software testing. For the biocompatibility testing, it mentions "the JM1" (implying the device itself), not a sample size of human subjects.
   • Data Provenance: Not specified. If a clinical study was performed for the predicate device, it's highly likely to have been prospective, but the location is not given. For this 510(k) relying on substantial equivalence, the "performance data" listed are primarily non-clinical.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable as no direct clinical study results requiring such expert assessment are detailed in this summary. If the predicate device had clinical studies assessed by experts (e.g., dermatologists or plastic surgeons grading wrinkles), that information is not present here.

3. Adjudication Method for the Test Set:

   • Not applicable as no direct clinical study results requiring adjudication are detailed in this summary.

4. 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 evidence of MRMC study: The device described is a light-based wrinkle treatment device, not an AI diagnostic imaging device that typically uses MRMC studies. Therefore, this type of study is not relevant to this device.

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

   • Not applicable. This is a physical treatment device, not a software algorithm for diagnosis that would have a "standalone" performance. Its "performance" refers to its ability to treat wrinkles when used by a human.

6. The Type of Ground Truth Used:

   • For non-clinical performance (safety): The ground truth for biocompatibility was established by recognized international standards (ISO 10993 series). Electrical and laser safety ground truth was established by compliance with IEC standards. Thermal performance ground truth was established through bench testing and ex vivo tissue evaluation against engineering safety limits.
   • For efficacy: The ground truth for efficacy is implicitly established by the predicate device's prior clearance for wrinkle treatment. The applicant argues that their new device is "as safe and as effective" as this predicate. No specific new clinical ground truth data for efficacy is presented in this summary document beyond the claim of substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI/machine learning algorithm that would typically have a "training set" in the context of data. It's a hardware device.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable (as above).

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