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MMSphere™Light Therapy Device emits energy in the red, blue and amber regions of the spectrum, specifically indicated to treat wrinkles and/or mild to moderate acne. The MMSphere™is designed to be used for 20 minute treatments three to seven times per week.

MMSphere™is an OTC, multi-use Light Therapy Device using LED light therapy technology for the treatment of mild to moderate wrinkles and/or acne. The device uses a combination of red light (625nm), blue light (465nm), and amber (605nm) to create different treatment settings. The user will wear provided goggles for treatments. Device can be used with handheld option or placed on a countertop.

The provided document is a 510(k) summary for the MMSphere™ Light Therapy System. It details the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain information about clinical studies with human subjects or a detailed breakdown of acceptance criteria and performance results in the format requested.

The document primarily focuses on:

• Bench performance testing: Demonstrating safety and effectiveness through compliance with consensus standards (ISO, ANSI/AAMI, IEC) for electrical safety, EMC, photobiological safety, and battery safety.
• Usability Testing: Assessing the ease of use with 35 subjects.

Therefore, many of the requested items regarding acceptance criteria, human study design, expert ground truth, and statistical results cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

• Information in document: The document mentions compliance with several technical standards (e.g., IEC 60601 electrical safety, IEC 60601 EMC, IEC 62471 photobiological safety). The "acceptance criteria" for these would be successful adherence to the requirements of these standards.
• Reported performance: The document states, "This device is in conformity with IEC 60601 electrical safety testing, IEC 60601 EMC testing and IEC 62471 photobiological safety testing." This is the reported performance – a statement of conformity, not specific numerical results against acceptance criteria.
• Detailed Table: A table with specific, quantifiable acceptance criteria and performance data for clinical efficacy (e.g., wrinkle reduction percentage, acne clearance rate) is not provided. The document states the device treats wrinkles and mild to moderate acne, but does not provide clinical data to demonstrate specific performance against these indications.

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

• Information in document: For the Usability Study, 35 subjects were used.
• Data Provenance: Not specified for the usability study (country, retrospective/prospective).
• Missing: There is no clinical test set mentioned for efficacy assessment.

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)

• Missing: This information pertains to clinical study ground truth establishment, which is not described in this 510(k) summary. The "experts" mentioned are primarily the submitter (Ellen Marmur, MD) and the FDA in their review process, but not in the context of establishing ground truth for a clinical efficacy test dataset.

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

• Missing: Not applicable as there is no described clinical efficacy test set with adjudicated ground truth.

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

• Missing: This is a laser/light therapy device, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). Therefore, an MRMC study is not relevant here and was not conducted.

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

• Missing: Not applicable, as this is a physical device for direct application, not a standalone algorithm.

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

• Missing: For clinical efficacy, the type of ground truth used is not described because no clinical efficacy study is detailed. For the usability study, the "ground truth" was the subjects' responses to a survey about ease of use.

8. The sample size for the training set

• Missing: No "training set" is mentioned, as this is not an AI/machine learning device.

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

• Missing: Not applicable, as no training set is mentioned.

Summary of Device Performance based on provided document:

The MMSphere™ Light Therapy System's "performance" in this 510(k) summary is demonstrated through:

• Bench Performance Testing: Asserted conformity with various international standards for electrical safety (IEC 60601-1), electromagnetic compatibility (EN 60601-1-2), photobiological safety (IEC 62471), and battery safety (IEC 62133-2). The document states conformity but does not provide specific data or acceptance limits for this.
• Usability Testing:
  • Sample Size: 35 subjects.
  • Methodology: Subjects were asked to turn the device on/off, change settings, demonstrate recharging, and complete a 10-question usability survey.
  • Findings/Improvements: Two specific concerns were identified:
    • Tightness of the ON/OFF/settings knob.
    • Recessed and not easily identifiable/accessible charging port.
  • Acceptance Criteria for Usability (Implied): While not explicitly stated, the goal was likely to identify usability issues that could be addressed. The document indicates these findings were addressed, suggesting the "acceptance" was that the device met a preliminary usability standard, or that identified issues were remediated.

Conclusion from document: The manufacturer asserts "no significant differences exist between the new device and the predicate devices and no new issues of safety or effectiveness are raised," leading to the conclusion of substantial equivalence. This statement serves as the overall "acceptance" in the context of a 510(k) submission, rather than meeting specific quantifiable performance metrics from a clinical study within this document.

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