(77 days)
The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgentic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenetic alopecia who have Ludwig-Savin Classifications I - II or Frontal and for both with Fitzpatrick Skin Phototypes I- IV.
The HairMax Laser 272, 202 or 80 each contain the listed number of diode 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 HairMax Laser 272, 202 and 80 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.
This FDA 510(k) summary for the HairMax Laser Models 272, 202, and 80 explicitly states that no clinical performance data was produced for this submission. The device's substantial equivalence is based on its identical technological characteristics and treatment regimen to already cleared predicate devices.
Therefore, the request for a table of acceptance criteria and reported device performance isn't applicable in the traditional sense of a study validating performance against specific criteria, as no such study was conducted for this submission. Similarly, information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not available in this document.
However, the document does describe an Over-The-Counter Testing Program to assess user comprehension and the suitability for OTC sale. I will detail that study.
Over-The-Counter Testing Program
1. Table of Acceptance Criteria and Reported Device Performance (for OTC Suitability):
| Acceptance Criteria | Reported Device Performance (HairMax Laser 272, 202, and 80) |
|---|---|
| 80% success rate (32 out of 40 subjects) answering all 26 questions correctly regarding: |
- Correct Self Selection (decision to purchase product or not based on Intended Use)
- Correctly assemble and use the product
- Comprehend hazards and maintenance procedures | 90% pass rate |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 40 volunteer subjects
- Data Provenance: Not specified, but implied to be a prospective study conducted for this submission, likely within the United States where the FDA submission is made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The ground truth for this study was the subjects' ability to correctly understand and interpret the product information (packaging and manual) without assistance. The "ground truth" was essentially the objective correct answers to the 26 questions. No external experts were used to establish this ground truth.
4. Adjudication Method for the Test Set:
- Single interviewer. Subjects were given a "P" (PASS) if all questions were answered correctly, and an "F" (FAIL) if any questions were answered incorrectly. No further adjudication among interviewers or experts is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a MRMC comparative effectiveness study was not done. This study was focused on user comprehension for Over-The-Counter suitability, not clinical efficacy or diagnostic accuracy.
6. If a Standalone Study Was Done (i.e., algorithm only without human-in-the-loop performance):
- This is not applicable as the device is a laser therapy product, not an AI algorithm. The OTC study assessed human comprehension of product information.
7. The Type of Ground Truth Used:
- The ground truth was established by the objective correct answers to the 26 questions derived directly from the product's standard retail package and full owner's manual.
8. The Sample Size for the Training Set:
- Not applicable. This study was a single test set for OTC suitability, not a machine learning study requiring separate training and testing sets.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (see point 8).
Summary regarding Clinical Performance:
It is crucial to reiterate that no clinical performance data was produced for this submission (K180885) to prove the device meets acceptance criteria for hair growth promotion. The substantial equivalence relies on the fact that the HairMax Laser 272, 202, and 80 are considered identical devices (private label, same manufacturer, same parts, same treatment regimen) to devices that were previously cleared by the FDA and presumably had clinical data submitted in their respective 510(k)s (K173678, K163170, K161875). Therefore, the clinical acceptance criteria and the studies proving them would be found in the documentation for those predicate devices, not in this specific 510(k) submission.
§ 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.