(54 days)
The Kiierr Family of Devices, the 272 and 148 Laser Devices are 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 of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
The Kiierr Family of Devices, the 272 and 148 Lasers each contain the listed number of diodes 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 Kiierr Family of Devices, the 272 and 148 Lasers are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical.
The provided document is a 510(k) summary for the Kiierr Family of Devices, Model 272 Premier & Model 148 Pro Laser Hair Growth Caps. It details the device's substantial equivalence to predicate devices rather than proving its performance through a new clinical study. Therefore, an "acceptance criteria" table as typically seen for AI/ML device performance studies, and information related to MRMC studies, standalone performance, training sets, and ground truth establishment cannot be fully provided as this information is not present in the given text.
The document focuses on demonstrating that the Kiierr devices are identical to already cleared predicate devices and, as such, do not require new clinical performance data. However, it does include an "Over-The-Counter Testing Program" which serves as a form of human factors or usability study, rather than a clinical efficacy trial.
Here's a breakdown of the information that can be extracted or deduced 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 acceptance criteria or reported performance for the efficacy of promoting hair growth for the Kiierr devices themselves, because it relies on the predicate devices' established performance. The only "performance data" mentioned is for an Over-The-Counter (OTC) Testing Program related to usability and comprehension, not clinical effectiveness.
Over-The-Counter (OTC) Testing Program Acceptance Criteria and Reported Performance:
| Acceptance Criteria (for usability/comprehension) | Reported Device Performance (Compliance with Criteria) |
|---|---|
| 80% success rate (32 out of 40 subjects) correctly answer all 26 questions related to: | Overall 90% pass rate for the subject group of 40 male and female participants. |
The testing demonstrated 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." The sponsor concludes the devices met requirements for OTC sale. |
| - Correct Self-Selection (making the correct decision to purchase the product or not based on intended use and manual). | |
| - Correct assembly and use of the product. | |
| - Comprehension of hazards and maintenance procedures for the device. | |
| Note: This OTC testing focuses on user comprehension and safe usage for an over-the-counter device, not on the clinical effectiveness of hair growth itself. The clinical effectiveness is deferred to the predicate device. | |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 40 subjects for the Over-The-Counter Testing Program.
- Data Provenance: The document does not specify the country of origin for the data for the OTC testing. It also doesn't explicitly state whether it was retrospective or prospective, but the description of "asking twenty-six questions, after being provided a standard retail package and a full owner's manual" strongly suggests a prospective usability study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the traditional sense for clinical ground truth. The "ground truth" for the OTC testing was based on the correctness of answers to 26 questions related to understanding the product packaging, manual, and safe/correct use. The document doesn't mention external experts to establish this "ground truth" beyond the implicit judgment of the device manufacturer or the study design in determining the correct answers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None specified. The "interviewer then conducted the interview and filled in the responses from the subjects." The assessment appears to be a direct comparison of subject responses against predetermined correct answers (P for PASS, F for FAIL). No multi-reviewer adjudication process is described for evaluating subject responses.
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 document is for a laser hair growth device, not an AI/ML-driven diagnostic or imaging analysis tool that would typically involve human readers.
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 AI algorithm. Its direct "performance" is based on the physical properties of the laser and its equivalence to predicate devices, not on a standalone AI algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the OTC testing: The "ground truth" was the pre-defined correct answers to questions assessing user comprehension of labeling, instructions for use, hazards, and maintenance. It's akin to a knowledge check or usability assessment standard, rather than medical ground truth from patient outcomes, pathology, or expert consensus on clinical findings.
- For the device's clinical efficacy: The document explicitly states: "No clinical performance data was produced for this submission because the Kiierr Family of Devices...are the same devices as the predicate... All proposed devices and predicate devices are IDENTICAL". Therefore, the "ground truth" for clinical efficacy of hair growth relies on the established performance and clearance of the predicate devices, not on new data for the Kiierr devices.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model for which a training set would be used for this submission.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set was used.
§ 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.