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The LG Pra.L Derma LD Scalp Care 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.

The LG Pra.L Derma LD Scalp Care utilizes a combination of laser diodes and light-emitting diodes (LEDs). 5-milliwatt laser diodes emit light from a range of wavelengths of about 650 nm to 667 nm, which is combined with light from 5 milliwatt LEDs emitting wavelengths from about 645nm to 665 nm. The combined light is absorbed by the scalp.

The LG Pra.L Derma LD Scalp Care is a dome shaped helmet with laser diodes and LEDs on the inside surface. By connecting a controller, the user can power the device on and off, start and pause treatment, and change the care mode. In addition, there is a charging cradle to place the controller in to charge the battery, and the status of the battery is displayed on the controller's indicator. The device can also be connected wirelessly via Bluetooth to a Smartphone App in order to manage treatment. After a treatment is completed, the LG Pra.L Derma LD Scalp Care device can automatically power off the laser, LEDs and controllers.

The provided text is a 510(k) Summary for the LG Pra.L Derma LD Scalp Care device. It describes the device, its intended use, and comparisons to predicate devices, but it does not contain detailed information about the acceptance criteria for a study proving device performance or the study itself in the format requested.

Specifically, the "Performance Data" section (6.6) mentions non-clinical tests (measurement of wavelength, power, irradiance, safety, EM compatibility, electrical safety) and usability testing with 34 participants. However, it does not present:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set (for efficacy)
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used (for efficacy)
• Sample size for the training set
• How ground truth for the training set was established

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (iGrow II Hair Growth System, K140931 and IllumiFlow Laser Cap, K162071) through technological characteristics and intended use, rather than presenting a detailed clinical efficacy study with specific acceptance criteria that would typically be required for a novel device or a device claiming a new indication.

Therefore, the information requested in the prompt cannot be extracted from the provided text. The document describes regulatory compliance and some physical performance characteristics, but not clinical performance data with acceptance criteria for a study demonstrating hair growth promotion in the detailed manner requested.

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