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The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum.

The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.

The provided FDA 510(k) clearance letter for the CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966) does not contain the detailed study information typically associated with acceptance criteria and clinical performance for an AI/ML device in the context of diagnostic performance (e.g., detecting a disease).

This device is an LED light therapy mask intended for treatment of full-face wrinkles, falling under the regulation 21 CFR 878.4810 (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology). The primary focus of the regulatory review for such a device is safety and effectiveness based on its physical properties and intended use for cosmetic purposes, rather than diagnostic accuracy or AI-driven image analysis.

Therefore, many of the requested elements are not applicable to the information provided in this document. The document explicitly states:

• "Clinical testing is not needed for this 510(k)."
• "The non-clinical performance testing described above is sufficient to demonstrate that the device can be used safely and effectively."

This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device through non-clinical tests (electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software verification/validation) and not on clinical performance metrics like sensitivity, specificity, or reader studies for diagnostic accuracy.

Addressing the Request Based on the Provided Document:

Given the nature of the device and the clearance documentation, I will answer the applicable points and explain why others are not present.

Acceptance Criteria and Device Performance for CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966)

The CurrentBody Skin™ LED Light Therapy Mask Series 2 is an LED phototherapy device for the treatment of full-face wrinkles. The acceptance criteria and performance evaluation for this device, as detailed in the 510(k) summary, are primarily focused on safety, electrical performance, material compatibility, and functional equivalence to a predicate device, rather than diagnostic performance metrics (e.g., accuracy in identifying wrinkles).

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device is primarily based on compliance with specific international safety and performance standards, and demonstrating substantial equivalence to a predicate device for its intended use. "Device performance" is therefore reported in terms of compliance with these standards and matching key operational parameters with the predicate.

2. Sample size used for the test set and the data provenance

Not applicable for performance evaluation in the context of typical AI/ML diagnostic devices. The clearance is based on non-clinical engineering and safety testing, component material equivalence, and functional equivalence to a predicate device. There is no "test set" of patient data or images in the conventional sense for evaluating diagnostic accuracy or clinical outcomes directly in this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth established by experts for a test set of clinical data, as no clinical performance study was conducted or required for this 510(k). Approval is based on safety, hardware specifications, and substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

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 is not a diagnostic AI device. No MRMC study was conducted or is relevant for this product's intended use (treatment of wrinkles).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hardware LED light therapy mask. While it has software for control (e.g., timer), it is not a standalone diagnostic algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's clearance is not related to clinical data or diagnostic accuracy. Instead, the "truth" is established by:

• Compliance with recognized international standards for electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility.
• Demonstration of substantial equivalence (same intended use, similar technological characteristics, and no new questions of safety or effectiveness) to a legally marketed predicate device (K221946).

For the purpose of treatment effectiveness validation in general, the underlying scientific basis for LED light therapy's effect on wrinkles (which is outside the scope of this specific 510k submission's clearance process details) would typically stem from clinical trials and dermatological research. However, this 510(k) relies on the predicate's established performance without new clinical studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data for learning or inference.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI/ML algorithm.

In summary, the provided 510(k) clearance letter details an approval based on substantial equivalence and compliance with safety and performance standards for a hardware medical device, not on the clinical performance or diagnostic accuracy of an AI/ML driven system. Therefore, many of the requested details regarding AI/ML study methodologies are not present in this document.

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The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm. The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.

The provided text does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (i.e., hair regrowth performance) with quantitative metrics for artificial intelligence (AI) performance. Instead, it refers to a 510(k) premarket notification for a medical device (CurrentBody Skin™ Led Hair Regrowth) which is largely relying on substantial equivalence to a predicate device (Revian Red).

The "acceptance criteria" and "device performance" mentioned in the document primarily relate to non-clinical performance testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, software validation), rather than clinical outcomes or AI performance. The document explicitly states: "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, I cannot directly fulfill all aspects of your request as it pertains to a study proving the device meets AI performance acceptance criteria or clinical efficacy data with AI assistance. However, I can provide the information available in the text regarding the non-clinical acceptance criteria and testing.

Here's an analysis based on the provided document:

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

Notes on Clinical Efficacy / AI Performance:

• This document is a 510(k) summary, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new major clinical trials for efficacy.
• The device (CurrentBody Skin™ Led Hair Regrowth) is a light-emitting diode (LED) device, not an AI software. The request itself is framed around AI performance, but the document describes a hardware device.

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

• Non-Clinical Testing: For most tests (General safety, EMC, Home healthcare, Particular requirements for light source equipment, Photobiological safety), the "Device Description/Sample Size" is stated as "The test sample is the final, finished product." This generally implies a very small sample size, often one or a few units, for regulatory compliance testing.
• Biocompatibility: The document states "All patient contacting materials are complied with ISO 10993-5, ISO 10993-10," citing prior clearance (K221444) for identical materials used in another device. This means the actual biocompatibility testing was likely performed for the predicate or a previously cleared device.
• Data Provenance: Not specified beyond standard lab bench testing for regulatory compliance. It's not clinical data.

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

• Not applicable. This is a hardware device undergoing non-clinical safety and performance testing for regulatory submission (510(k)). There is no "ground truth" derived from expert consensus for clinical outcomes or AI performance, as no clinical efficacy study or AI component is described as being part of the evaluation for this submission.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically performed for imaging diagnostic AI devices to compare human reader performance with and without AI assistance. This document describes a therapeutic LED device, not a diagnostic AI. The document explicitly states: "Clinical testing was not needed for this 510(k)."

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

• Not applicable. The device is a physical LED hair regrowth cap, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable for clinical efficacy or AI performance. For the non-clinical tests, the "ground truth" is defined by the requirements and performance limits specified in the referenced international standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. See point 8.

In summary, the provided document focuses on the regulatory clearance process for a physical medical device (LED hair regrowth cap) based on substantial equivalence and compliance with non-clinical safety and performance standards. It does not contain information about studies involving AI, human reader performance, or detailed clinical efficacy trials with quantifiable acceptance criteria for hair regrowth.

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