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The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. All users should also have Fitzpatrick Skin Types I to IV.

The Hair Growth Device LS-D620 is composed of 80 laser diodes (wavelength: 650-660nm, power

It appears the provided document is a 510(k) premarket notification for a medical device called "Hair Growth Device" (Models LS-D620 and LS-D630). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit performance acceptance criteria and a detailed study report.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical performance study with predefined endpoints and statistical analysis.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the proposed device's technical characteristics and intended use to predicate devices to argue that it raises no new questions of safety or effectiveness.
• Non-Clinical Testing: Demonstrating compliance with various safety standards (biocompatibility, electrical safety, EMC, laser safety, software validation).
• Usability Study: To show that users can safely and effectively use the device according to the manual.

Here's a breakdown of why the requested information isn't present in this document:

1. A table of acceptance criteria and the reported device performance: This is not provided. The 510(k) process doesn't typically require a clinical performance study with specific acceptance criteria in the same way a PMA or De Novo submission would. The "performance" demonstrated here is primarily related to safety, electrical output consistency, and user understanding, not a specific clinical efficacy metric like "percentage of hair growth subjects achieving X density increase."

2. Sample size used for the test set and the data provenance: Not applicable for a clinical performance test set. The usability study involved 15 participants for each model. Data provenance is not specified beyond "testing of 15 participants was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical "test set" requiring ground truth established by experts for a performance metric.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 a device for hair growth, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for device performance in the clinical efficacy sense. For non-clinical tests like biocompatibility, the "ground truth" is adherence to ISO standards and passing specific assays. For the usability study, the "ground truth" is whether participants could safely and effectively use the device based on observation and feedback.

8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is available from the document:

• Non-Clinical Tests Performed:
  • Biocompatibility Testing: Per ISO 10993-1:2018 (including in vitro cytotoxicity, skin sensitization, and skin irritation). All tests passed.
  • Electrical Safety and Electromagnetic Compatibility Testing: Complied with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015.
  • Laser Safety: Complied with IEC 60825-1:2007.
  • Software Verification and Validation: Documentation consistent with moderate level of concern, system validation testing demonstrated all software requirement specifications are met and hazards mitigated.
• Usability Study:
  • Sample Size: 15 participants for LS-D620, 15 participants for LS-D630.
  • Findings: Participants were able to understand the user manual and box labeling and were able to safely and effectively use the device.

The document concludes that based on the non-clinical tests and usability study, and the substantial equivalence to predicate devices, the Hair Growth Device LS-D620, LS-D630 does not raise new types of questions regarding its safety and efficacy.

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