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The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

The CurrentBody Skin Dual Light Hair Growth Helmet (model:MZ-07A) is an over-the-counter device designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to promote hair growth in females who have Ludwig-Savin Classifications of I-II; both with Fitzpatrick Skin Types I-IV.

The device consists of 100 laser diodes with wavelength at 655±5nm, and 200 red light diodes with wavelength at 660±5nm.

The CurrentBody Skin Dual Light Hair Growth Helmet includes a hair-growing cap, a device base and a USB power cord. There are LEDs and lasers diodes inside the cap to emit visible red light, the device base acts as a support when the device is not used. There is a power button on cap to turn on/off the device, a digital display to show the remaining treatment time, an power indicator to show charging status and a USB port for charging.

The treatment parameter is pre-set by manufacturer, the device will auto off after treatment.

The provided FDA 510(k) clearance letter and summary for the CurrentBody Skin Dual Light Hair Growth Helmet (K251017) indicate that clinical performance testing was explicitly stated as "not needed" for this 510(k) submission. Therefore, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria based on clinical performance data.

The submission relies on non-clinical performance testing to demonstrate substantial equivalence and safety/effectiveness. This non-clinical testing focuses on electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software validation.

Here's a breakdown of why the requested information about acceptance criteria and a clinical study proving performance cannot be extracted from this document, along with information that is available:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

Since no clinical performance study was provided, there are no specific performance acceptance criteria for hair growth or efficacy reported in the document. The acceptance criteria for this submission are related to meeting established safety and performance standards through non-clinical testing.

Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:

Regarding a Clinical Study (Not Applicable for this Submission)

As stated in Section 7.2 of the 510(k) Summary:
"Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the following information, which would typically be included for a clinical study proving efficacy/performance, is not available in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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 is generally for diagnostic AI devices, not a therapeutic device like this).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable (referring to clinical training data for performance, not engineering/software validation training).
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Claim Basis for Hair Growth:

The claim about promoting hair growth is based on:

• Substantial Equivalence: The primary strategy for clearance is demonstrating that the CurrentBody Skin Dual Light Hair Growth Helmet is substantially equivalent to legally marketed predicate devices (K231153: Neuhat Hair Growth System; K240456: Bosley Booster Laser Caps). The predicate devices were previously cleared for the same indication (promote hair growth in specific Norwood-Hamilton and Ludwig-Savin classifications with Fitzpatrick Skin Phototypes I-IV).
• Similarity in Design and Parameters: The submission highlights similarities in the intended use, indications for use, type of light (low-level laser and LED), wavelength (very close to predicates), number of diodes, energy per laser diode, and treatment time/irradiance (very close to predicates). The argument is that these similarities mean the subject device will have a similar therapeutic effect to the already-cleared predicate devices.
• Non-Clinical Data: As detailed in the table above, the non-clinical testing ensures the device meets safety standards (electrical, EMC, photobiological, battery, biocompatibility, software) which indirectly supports its safe use for its intended purpose without raising new questions of safety or effectiveness compared to the predicates.

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