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Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.

Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user's scalp to ensure the laser light reaches the user's scalp. Model Hat-01 contains 82 laser diodes.

The provided text is a 510(k) summary for the "Laser Cap, Model: Hat-01" device. It outlines the regulatory clearance process and compares the device to predicate devices. However, it does not contain information about acceptance criteria for a study proving device performance, nor details of such a study.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and adherence to safety and electromagnetic compatibility (EMC) standards.

Specifically, the "Performance Data" section (numbered VIII) lists biocompatibility testing and electrical and EMC safety testing. These are general compliance tests for medical devices, not a study designed to prove the efficacy of the "Laser Cap" in promoting hair growth against established acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance: This information is not present.
2. Sample size used for the test set and data provenance: No efficacy study is described.
3. Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical efficacy study is detailed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study details: No such study is mentioned.
6. Standalone (algorithm-only) performance: This device is a physical laser cap, not an algorithm.
7. Type of ground truth used: Not applicable, as no clinical efficacy study is detailed.
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI/ML model being trained.
9. How ground truth for the training set was established: Not applicable.

The document's purpose is to show that the new device is as safe and effective as existing, cleared devices, primarily through comparison of design, materials, and compliance with general safety standards, rather than presenting a novel clinical efficacy study.

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