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Hair Growth System, Models: SPARK-3 and SPARK-4 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwing -Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood -Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

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This document is an FDA 510(k) clearance letter for a "Hair Growth System", not a study report or clinical trial summary. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving device performance.

The provided text only includes:

• General FDA clearance information.
• The device name, regulation number, regulatory class, and product code.
• The indications for use for the Hair Growth System.

It emphatically does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Details about training set size or how its ground truth was established.

Without a clinical study report or a summary of the performance data submitted for the 510(k) clearance, these questions cannot be answered from the provided text.

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