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The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.

The LCPro consists of 224 red, visible-light, pulsed-emission diode lasers operating at 650 nanometers, that are configured within a protective inner liner and outer helmet. The LCElite is physically similar to the LCPro, except that it is configured with 80 red, visible-light, continuous-emission diode lasers, also operating at 650 nanometers and also configured within a protective inner liner and outer helmet. The use of these specific number of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Lithium Ion battery cells assembled into a proprietary battery pack. Both the battery cells pack and charger are fully compliant to recognized, international standards.

This document describes a 510(k) premarket notification for the LaserCap LCPro and LCElite devices. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories (e.g., sample size, expert ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they relate to clinical studies that were not performed or submitted for this 510(k).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific performance metrics (e.g., hair growth percentage, hair count increase) from a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

However, it does state an Intended Use / Indications for Use:
"The LCPro and LCElite are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and Fitzpatrick Classification of Skin Phototypes I to IV."

Device Characteristics provided:

The performance data states: "No Clinical trial data for LCPro and LCElite were submitted for this 510(k)."

2. Sample size used for the test set and the data provenance: Not applicable – No clinical trial data was submitted or referenced as a test set for this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable – No clinical trial data was submitted or referenced, so no ground truth establishment by experts is detailed for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable – No clinical trial data was submitted or referenced, so no adjudication method for a test set is detailed.

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 device for hair growth, not an AI-assisted diagnostic or therapeutic device for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable – This device does not involve an algorithm or AI for standalone performance evaluation in the context described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable – No clinical trial data requiring ground truth for performance evaluation was submitted.

8. The sample size for the training set: Not applicable – No clinical trial data or algorithm requiring a training set was part of this 510(k) submission.

9. How the ground truth for the training set was established: Not applicable – No clinical trial data or algorithm requiring a training set was part of this 510(k) submission.

Summary of the document's approach to "proving" the device meets criteria:

Instead of a clinical study demonstrating acceptance criteria, the 510(k) application for the LaserCap LCPro and LCElite relies on the concept of substantial equivalence to legally marketed predicate devices.

The document indicates the following about how the device "meets acceptance criteria" (in the context of substantial equivalence):

• Technological Characteristics: The LCPro and LCElite utilize similar technological characteristics (red light diode lasers, 650 nm wavelength) to the predicate devices (Capillus272 Pro and Theradome LH 80 Pro). The LCPro uses pulsed emission similar to Capillus272 Pro, and the LCElite uses continuous emission similar to Theradome LH 80 Pro.
• Energy and Irradiance Output: The devices provide "similar energy and irradiance output to the treatment area" as their respective predicates.
• Intended Use: The intended use of promoting hair growth in females with androgenetic alopecia (Ludwig-Savin Classifications I-II, Fitzpatrick Skin Phototypes I-IV) is the same as the predicate devices.
• Safety and Effectiveness: The sponsor believes that "the differences between the subject devices of this 510(k) compared with the predicate devices, do not substantially affect the therapeutic value or the safety profile."
• Standards Conformance: The devices were tested for conformance with several international standards: IEC 60825-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133. This demonstrates basic electrical safety and electromagnetic compatibility compliance, which are general controls for medical devices.

In essence, the "proof" for this 510(k) is the demonstration that these new devices are sufficiently similar to already cleared devices that they are considered substantially equivalent, implying they carry the same level of safety and effectiveness as the predicates without the need for new clinical data.

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