(89 days)
ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.
The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.
The provided text describes the ID-500 iRestore Hair Growth System and its substantial equivalence to a predicate device, the iRestore Professional 282. However, it does not include detailed acceptance criteria for a device performance study in terms of clinical outcomes (e.g., hair count increase) or a study proving the device meets those clinical criteria. Instead, the document focuses on non-clinical performance data demonstrating safety and electrical/laser compliance.
Therefore, many of the requested elements for a clinical performance study (like sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not available in this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
The document primarily discusses acceptance criteria related to safety and engineering standards, not clinical efficacy.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Cytotoxicity testing per ISO 10993-5 | Passed |
| Irritation testing per ISO 10993-10 | Passed |
| Sensitization testing per ISO 10993-10 | Passed |
| Electrical safety testing per ANSI AAMI ES60601-1:2005((R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Passed |
| Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 | Passed |
| Home used environment testing per IEC 60601-1-11 | Passed |
| Laser safety testing per IEC 60825-1 | Passed |
| Software verification and validation per FDA Guidance | Compliant |
| Product life time testing | Supports life time of 5 years |
| Transportation testing per ASTM D4169-16 | Demonstrates package integrity maintained |
2. Sample size used for the test set and the data provenance:
This information is not provided as there is no description of a clinical performance study with a test set of human subjects. The "test set" here refers to the samples used in the non-clinical tests (e.g., cytotoxicity tests would use cell cultures or animal models, electrical safety tests would use the device itself). The document does not specify details about these samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no mention of a human-centric performance study where experts would establish a ground truth for clinical outcomes like hair growth. The "ground truth" for the non-clinical tests would be defined by the standards themselves (e.g., a cytotoxicity assay result being below a certain threshold).
4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.
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:
This information is not applicable. The device described is a low-level laser/light therapy system for hair growth, not an AI-powered diagnostic tool requiring human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the harmonized standards (ISO, ANSI, IEC, ASTM) and FDA guidance documents that the device was tested against. For example:
- Safety standards: Passing specific thresholds for electrical leakage, laser emission limits, or biocompatibility responses.
- Software compliance: Adherence to defined software development and validation practices.
- Lifetime/Transportation: Meeting predefined engineering specifications for durability and package integrity.
8. The sample size for the training set:
This information is not applicable as the device is a hardware product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
Summary of the Study:
The document describes a non-clinical performance study focused on demonstrating the safety and engineering compliance of the ID-500 iRestore Hair Growth System. The study involved testing the device against various national and international standards related to biocompatibility, electrical safety, electromagnetic compatibility, home use environment, laser safety, software validation, product lifetime, and transportation durability. The results of these tests confirmed that the device met the design inputs and performance specifications required by these standards, supporting its safety and effectiveness from an engineering and manufacturing perspective, and its substantial equivalence to the predicate device. No clinical efficacy study or AI-related performance study is detailed in this document.
§ 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.