(158 days)
The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
The iRestore Professional 282 consists of 82 red visible light, diode lasers and 200 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down. by emitting an audible beep pattern.
The provided document describes the acceptance criteria and study for the iRestore Professional 282 device, primarily focusing on its suitability for Over-the-Counter (OTC) sale rather than clinical efficacy against a disease endpoint. The core of the "study" is a usability test to confirm consumer comprehension and safety handling, and then establishing substantial equivalence to a predicate device for clinical performance.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For OTC Usability and Comprehension: | |
| 80% success rate (24 out of 30) of subjects answering all questions correctly regarding self-selection, product assembly & use, hazards, and maintenance. | 90% pass rate for the subject group of 30 male and female participants. |
| Demonstration that age, education, socioeconomic group, race, or medical hair loss status do not prevent proper self-selection, usability, and comprehension. | The testing "further demonstrates that age, education, socioeconomic group, race or medical hair loss status are not variants that prevent proper self-selection, usability and comprehension of hazards and maintenance procedures for the average consumer to successfully navigate the purchasing and use process of the iRestore Professional 282." |
| For Clinical Performance (via Substantial Equivalence): | |
| Substantially equivalent in safety and effectiveness to the predicate device (iRestore Hair Growth System, K151662). | The sponsor states: "The iRestore Professional 282 device is similar to the device known as the iRestore Hair Growth System...It is as safe and effective as the predicate device." "The sponsor believes that the difference in the physical appearance or in the method of delivering the radiant energy of the two systems is essentially the same and does not alter the safety profile." |
2. Sample size used for the test set and the data provenance
- Sample Size: 30 subjects
- Data Provenance: The document does not explicitly state the country of origin or whether it was retrospective or prospective. Given the nature of a usability test for OTC readiness, it is most likely a prospective study conducted in the United States (implied by FDA submission) at the time of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document primarily describes an OTC usability study and relies on substantial equivalence for clinical efficacy.
- For the OTC Usability Test: The "ground truth" was established by the "interviewer" who filled in the responses. The document does not specify the number or qualifications of the interviewer(s), but implies they were conducting a structured interview based on the questions provided. Given the nature of this usability test, the "ground truth" isn't a medical interpretation by experts, but rather the objective correctness of the user's answers to predefined questions.
- For Clinical Efficacy: No new clinical ground truth was established. The device's "efficacy" acceptance is based on its substantial equivalence to a predicate device (iRestore Hair Growth System K151662), which presumably had its efficacy established in a prior submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For the OTC Usability Test: None. The judgment was based on whether the subject answered "all questions correctly" (Pass) or "any questions incorrectly" (Fail). There was no mention of multiple reviewers or an adjudication process for the subject's answers. The interviewer directly assessed the correctness of the answers.
- For Clinical Efficacy: Not applicable, as no new clinical study was performed.
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 MRMC comparative effectiveness study was done. This device is a therapeutic device (for hair growth), not an AI-assisted diagnostic or assistive device that would typically involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a light-based therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the OTC Usability Test: The ground truth was based on pre-defined correct answers to questions about the product packaging and manual. The "correctness" of these answers served as the ground truth for user comprehension and self-selection.
- For Clinical Efficacy: The clinical efficacy of the iRestore Professional 282 is implicitly derived from the established efficacy of its predicate device (iRestore Hair Growth System K151662) based on the argument of substantial equivalence. This would mean the predicate device likely had its efficacy proven through outcomes data (e.g., hair count, observer assessment, subject self-assessment) in its own clinical trials. The current submission did not generate new clinical outcomes data.
8. The sample size for the training set
Not applicable. This submission describes a medical device, not an AI/algorithm that requires a training set. The "study" here is a usability test and a comparison to a predicate device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm.
N/A