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The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.

The Laser hair growth helmet (Model: A-800) is hands-free, portable, non-invasive, low-level laser device, which consists of red visible light diode lasers, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically suspend the work if it is removed from scalp, and the power blue light indicator flashes.

The medical device is the Laser hair growth helmet (Model: A-800), intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II and males with Norwood Hamilton Classifications IIa-V, both with Fitzpatrick Classification of Skin Phototypes I-IV.

1. A table of acceptance criteria and the reported device performance:

The provided document does not contain explicit "acceptance criteria" for clinical performance. Instead, it states that "Clinical performance is not deemed necessary" and focuses on demonstrating substantial equivalence to predicate devices through technical specifications and safety/performance bench testing. The device's performance is therefore reported in terms of its technical characteristics matching or being comparable to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test set was used for this submission. The submission explicitly states: "Clinical performance is not deemed necessary." The data provenance for the performance testing is from laboratory bench testing.

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

Not applicable, as no clinical test set was used and clinical performance was not deemed necessary.

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

Not applicable, as no clinical test set 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 device is a laser hair growth helmet, not an AI-assisted diagnostic or interpretative tool.

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

Not applicable. This is a physical device, not an algorithm, and the submission did not include standalone clinical performance testing.

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

No clinical ground truth was established or used, as no clinical trials were conducted for this submission. The "ground truth" for demonstrating device compliance was based on adherence to recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as verification and validation for integral software.

8. The sample size for the training set:

Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.

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

Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.

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Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.

The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains the listed number of diode lasers configured within an outer cap helmet and protective inner liner. The use 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 LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip.

The provided text is a 510(k) summary for the LaserCap Family of Lasers, models 300, 224, 120, and 80, seeking Over-The-Counter (OTC) clearance for devices previously cleared for prescription-use. The core argument for substantial equivalence relies on the fact that the proposed OTC devices are identical to the previously cleared prescription-use predicate devices in their design, function, and performance. Therefore, no new clinical performance data or testing was performed for this submission.

This means that the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, because such studies were deemed unnecessary due to the device's substantial equivalence to already cleared devices.

The document explicitly states:

• "No clinical performance data was produced for this submission because the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 are the same device as the Predicates..." (Page 4)
• "No OTC testing was performed for this submission because the User Manual and packaging contents for the predicates and reference devices, are substantially equivalent to the Reference Devices." (Page 5)
• "Biocompatibility, electrical safety and EMC testing is not needed in this submission because the subject device is identical to the predicate devices in these aspects." (Page 6)

In summary, the provided text does not include the details of a study that proves the device meets acceptance criteria in the way typically expected for a new or novel device. Instead, it relies on the established safety and efficacy of its identical predicate devices. Therefore, I cannot construct the requested table or answer most of the questions, as the information is not present in the provided context.

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CAPOGEN Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

The CG-272 CAPOGEN Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack. The CG-148 CAPOGEN Laser Cap is exactly the same as the CG-272 with the exception of the number of diodes which is respective of model (148 diodes in CG-148).

The provided text is a 510(k) summary for the CAPOGEN Laser Cap. It outlines the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document does NOT describe the acceptance criteria and the study that proves the device meets those acceptance criteria in the format typically associated with an AI/ML medical device approval for performance.

This 510(k) is for a "Laser Cap" (a physical device for hair growth), not an AI/ML algorithm. The performance data section refers to:

• Biocompatibility Testing: Ensuring the device materials are safe for human contact.
• Electrical and EMC Safety: Ensuring the device operates safely in terms of electrical hazards and electromagnetic compatibility.
• Laser Classification: Confirming the laser system meets safety standards.

The "study that proves the device meets the acceptance criteria" in this context is the sum of these engineering and biological safety tests, demonstrating that the device is as safe and effective as its predicate. There is no AI/ML component described, therefore no need for the detailed AI/ML-specific study design elements you requested (sample size for test/training, expert adjudication, MRMC studies, standalone performance, ground truth establishment, etc.).

Therefore, it is not possible to fill in the requested table and information as the document does not pertain to the performance evaluation of an AI/ML medical device for diagnostic or prognostic purposes.

The closest analogue to "acceptance criteria" here would be passing the specified safety and biocompatibility standards, and for "reported device performance," it would be the statement "CAPOGEN Laser Cap was found to have a safety and effectiveness profile that is same as the predicate device."

Summary of what CANNOT be extracted from this document regarding AI/ML device performance:

1. Table of acceptance criteria and reported device performance: Not applicable for AI/ML performance metrics. The "performance" here is about safety and electrical compliance.
2. Sample size for the test set and data provenance: No test set in the AI/ML sense is mentioned.
3. Number of experts used to establish ground truth and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only) performance: Not applicable, as there's no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document demonstrates substantial equivalence based on design, materials, intended use, and safety performance compared to a predicate device, which is a common pathway for physical medical devices.

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The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenic alopecia who have Ludwig-Savin Classifications I - II, and for both, with Fitzpatrick Skin Phototypes I- IV.

The Shapiro MD, Model Laser 272 is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack.

This document describes a 510(k) premarket notification for the Shapiro MD, Model Laser 272, a low-level laser therapy (LLLT) device intended to promote hair growth. However, it's crucial to understand that this submission does not involve clinical performance studies or the establishment of ground truth as would be typical for an AI/ML device.

The core of this submission is a claim of substantial equivalence to a previously cleared predicate device (Diode Laser Cap, K173678). This means the manufacturer is asserting their device is so similar to an already approved device that it does not require new clinical data to prove its safety and effectiveness.

Therefore, many of the requested elements for describing "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not applicable to this 510(k) submission. There is no AI/ML component described, and no performance study was conducted to demonstrate efficacy of the new device itself.

Based on the provided text, here's an analysis addressing the requested points where applicable, and explaining why others are not:

1. A table of acceptance criteria and the reported device performance

Since no clinical efficacy study was conducted for this specific device, there are no "acceptance criteria" related to a performance metric like sensitivity, specificity, or accuracy that would be proven through a study. The "acceptance criteria" in this context are the criteria for demonstrating substantial equivalence to the predicate device.

Acceptance Criteria (for Substantial Equivalence):

Reported Device Performance:
The document explicitly states: "No clinical performance data was submitted because the Shapiro MD, Model Laser 272 is the same device as the predicate, the Diode Laser Cap, cleared under KI 73678. The proposed device and predicate devices are IDENTICAL and the same device is offered for PRIVATE LABEL by the manufacturer."

Instead of clinical performance, the reported "performance" for this submission is conformance to consensus international standards:

• IEC 60601-1:2005 + CORR. 1: 2006 + CORR. 2: 2007 + A1: 2012 (Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2: 2014 (Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances-Requirements and Tests)
• ISO 10993-5 2009 (Biological Evaluation of Medical Devices Part 5 Tests for In Vitro Cytotoxicity)
• ISO 10993-10: 2010 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization)
• IEC 60825-1 Edition 2.0 2007 03 (Laser Safety & Classification)
• IEC 62133 (Battery Cells) and IEC60950 (Battery Charger)

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

• Sample size: Not applicable. There was no clinical test set for performance because no clinical study was conducted for this device. The "test set" for substantial equivalence was the comparison of specifications between one instance of the new device and the predicate device's specifications.
• Data provenance: Not applicable for clinical performance. The data provenance for the substantial equivalence claim comes from the technical specifications of the current device and the FDA-cleared predicate device.

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

• Number of experts: Not applicable. No ground truth was established through expert review for clinical performance data, as no such data was generated for this submission. The "ground truth" for the substantial equivalence assertion is the detailed technical specifications of both devices.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No clinical test set requiring adjudication was used. The substantial equivalence was asserted by the manufacturer and reviewed by the FDA.

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

• MRMC study: No.
• Effect size: Not applicable. This device is not an AI/ML diagnostic tool and does not involve human readers. It is a therapy device.

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

• Standalone performance: Not applicable. This device is a direct-to-consumer therapy device, not an algorithm.

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

• Type of ground truth: Not applicable for a clinical performance study. The "ground truth" for this 510(k) submission's purpose of demonstrating substantial equivalence is the technical specifications and indications for use of the predicate device, as stated in its original 510(k) clearance.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground truth for training set: Not applicable.

In summary: The provided document is a 510(k) clearance letter for a medical device (laser hair growth device) based on substantial equivalence to a predicate device, not on new clinical performance data generated by the applicant for this specific submission. Therefore, most of the questions pertaining to testing, ground truth establishment, and AI/ML performance metrics are not relevant to this type of regulatory submission. The "study" proving it meets "acceptance criteria" here is the comparison of its technical characteristics and indications for use against a predicate device, and finding them to be identical.

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