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iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.

Here's an analysis of the provided text regarding the iHelmet Hair Growth System's acceptance criteria and studies, organized according to your requested points.

It's important to note that this document is a 510(k) summary for a medical device aiming for substantial equivalence to existing devices. As such, the "studies" described primarily focus on bench testing and comparisons to predicates to demonstrate safety and performance under established standards, rather than formal clinical effectiveness trials with human subjects. There is no mention of a traditional algorithm-based AI system with ground truth development in the context of the provided document. The device is a physical product (infrared lamp for hair growth), not a diagnostic AI system.

Therefore, many of your requested points regarding AI-specific criteria (e.g., ground truth establishment for a test set, AI vs. human reader effectiveness, adjudication methods) are not applicable or cannot be extracted from this documentation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as maintaining specific physical and operational parameters. The reported performance is the device's adherence to these standards and its performance within defined limits, making it "substantially equivalent" to predicate devices.

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

• Sample Size: Not applicable in the context of human subjects or a data test set for an AI model. The "test set" in this document refers to the physical device undergoing various bench tests and comparisons against engineering specifications and predicate devices. No specific "sample size" of a dataset for algorithmic evaluation is mentioned because this is not an AI diagnostic or analytical device.
• Data Provenance: Not applicable. The "data" here comes from direct measurements and compliance testing of the physical iHelmet device itself, against pre-defined engineering standards and benchmarks set by predicate devices.

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

• Not Applicable. This document does not describe the establishment of ground truth by experts for a dataset, as it pertains to a physical medical device (infrared lamp) for hair growth, not an AI system that interprets data or images. The "ground truth" for this device's performance is adherence to established engineering standards and safety limits, and demonstration of substantial equivalence to already cleared devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies to resolve discrepancies among human readers or experts when establishing ground truth for diagnostic AI. This document describes bench testing and comparison studies of a physical device.

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

• No. An MRMC study is not mentioned as this device is not an AI-assisted diagnostic tool for human readers. It is a direct-to-consumer medical device for hair growth.

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

• Not Applicable. This is not an algorithm. It is a physical device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to international consensus standards (e.g., IEC, ISO) for electrical safety, laser safety, biocompatibility, and performance, along with demonstrating substantial equivalence to previously cleared predicate devices.
• For biological parameters like hair growth, the ground truth for the predicate devices' effectiveness would have been established through clinical trials (but those trials are not part of this 510(k) submission, which relies on the predicate's prior clearance). The current submission focuses on demonstrating that the new device meets the same safety and performance profiles as the predicates.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI system that requires a "training set" in the machine learning sense.

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

• Not Applicable. As there is no AI training set, there's no ground truth establishment for it.

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iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.

iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.

The provided text is a 510(k) summary for the iHelmet Hair Growth System (Model: LTD200S). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical outcomes.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this regulatory document. This document primarily addresses safety and performance through bench testing and comparison to a predicate device.

Here's a breakdown of the information that can be extracted or inferred from the provided text, addressing your points where possible:

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

The document does not present clinical acceptance criteria for hair growth or efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards. The "acceptance criteria" here are compliance with recognized safety standards and similarity to the predicate device.

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