(303 days)
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.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (General Requirements for Safety) | Complied with IEC 60601-1 (2005+A1:2012) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (EMC Requirements and tests) | Complied with IEC 60601-1-2 (Edition 4.0 2014-02) |
| Laser Safety | Compliance with IEC 60825-1 (Equipment classification and requirements) | Complied with IEC 60825-1 (2007-03); Classified as Class 3R (matching predicates) |
| Home Healthcare Environment Safety | Compliance with IEC 60601-1-11 (Requirements for Medical Electrical Equipment and Systems Used) | Complied with IEC 60601-1-11 (2010) |
| Biocompatibility (Cytotoxicity) | Compliance with ISO 10993-5 (Tests for In Vitro cytotoxicity) | All patient contacting materials are complied with ISO 10993-5 (2009) |
| Biocompatibility (Sensitization & Irritation) | Compliance with ISO 10993-10 (Tests for irritation and skin sensitization) | All patient contacting materials are complied with ISO 10993-10 (2010) |
| Temperature | Max. temperature between device and scalp not to exceed 43°C during operation (per IEC 60601-1) | Temperature test conducted; highest temperature between iHelmet and scalp would not exceed 43°C during operation. |
| Operational and Physical Parameters | Parameters (e.g., wavelength, power, treatment time, etc.) to be within clinically acceptable ranges and comparable to predicates to claim substantial equivalence. | Wavelength: 650nm±10nm (matches predicates) |
| Energy per Laser Lamp: 4~5mW (matches predicates) | ||
| Classification (Laser): Class 3R (matches predicates) | ||
| Differences in Laser Lamp Amounts, Treatment Time, Treatment Area, Irradiance, Fluence: Acknowledged but "can be covered by predicate device's several models' range" and "will not raise any safety or effectiveness issue." | ||
| Mechanical/Environmental Parameters | Weight, Dimensions, Environment for Operation/Storage to be acceptable for intended use. | Differences from predicates acknowledged but "will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements" and "will not affect the critical functions or the normal use." |
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.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.