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LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopeda who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of lla-V and for both, Fitzpatrick Skin Phototypes I to IV.

LaserCap300, LaserCap224, LaserCap120, and LaserCap80 consist of red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. The devices only vary in number of lasers (300, 224, 120, and 80 diodes, respectively) and LaserCap300 has a small extension of the LaserCap housing perimeter where its additional laser diodes target peripheral hair-bearing areas of the scalp. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (1 short beep) or ended (one long beep). The portable systems are powered by rechargeable Li-lon battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.

The provided text describes the regulatory filing for the "LaserCap" family of devices (LaserCap300, LaserCap224, LaserCap120, LaserCap80) for promoting hair growth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study to prove new acceptance criteria.

Therefore, the information you requested about acceptance criteria met by a specific study is not directly available in the provided text as the application relies on proving similarity to already approved devices.

However, I can extract information related to the device's performance based on the substantial equivalence argument, which implies that the device meets the same safety and effectiveness standards as the predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating sameness to predicate devices that have already met regulatory standards. The reported device performance is therefore described in terms of its technological characteristics matching, or being acceptably similar to, predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• The document does not describe a specific clinical "test set" used for the LaserCap devices to demonstrate new clinical efficacy or safety. The argument is based on substantial equivalence to existing predicate devices.
• The data provenance mentioned relates to the standards the devices conform to (e.g., IEC standards accepted by the FDA) and the history of no reported adverse events for this technology generally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. The document does not describe a clinical study with a "test set" requiring experts to establish ground truth for the new LaserCap devices. The ground truth for the predicate devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set described for the LaserCap devices.

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 device is a low-level laser therapy (LLLT) device, not an AI or imaging device that would typically involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a medical device for therapy, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the LaserCap devices is implicitly that they are equivalent to the predicate devices and thus promote hair growth and are safe, aligning with existing clinical evidence for LLLT for androgenetic alopecia.
• For the predicate devices, the original ground truth would have been based on clinical studies demonstrating efficacy (e.g., hair count, global photographic assessment) and safety outcomes for hair growth promotion in the specified populations.

8. The Sample Size for the Training Set

• Not applicable. The document does not describe a "training set" for an algorithm. The "training" for the substantial equivalence argument relies on the existing body of evidence and regulatory approvals for LLLT devices.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set described.

In summary, the provided document is a 510(k) summary for medical device clearance based on substantial equivalence. It argues that the LaserCap devices are as safe and effective as already legally marketed predicate devices, and therefore do not require new, extensive clinical studies to establish their own acceptance criteria or separate clinical ground truth.

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