(85 days)
The Hair Up is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
The Hair Up is basically an identical device with the 510(k)-cleared device Hair Up (K172968). A new 510(k) clearance is applied this time with a new indications for use (IFU). Subject device, Hair up and its primary predicate device consist of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides full coverage of the upper 1/3 of the head which is commonly covered with stylized hair. The system will automatically pause therapy until the correct head position is re-established. At the end of the therapy cycle, the subject device Hair Up signals that therapy is complete and the device is ready to be powered down.
The provided text is a 510(k) summary for the "Hair Up" device, an infrared lamp intended to promote hair growth. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness in promoting hair growth.
The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technical characteristics and indications for use. The "Performance Data" section describes non-clinical tests related to safety, electrical requirements, and biological evaluation, not a clinical study on hair growth.
Therefore, I cannot provide the requested table and detailed study information based on the given input. The categories below are answered based on the information that is available in the document, and where information is not present, it is explicitly stated.
Acceptance Criteria and Device Performance Study Information for Hair Up
This 510(k) summary for the "Hair Up" device does not contain a clinical study with acceptance criteria and reported device performance related to its primary intended use of promoting hair growth. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical safety testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hair Growth | Not provided in this document | Not provided in this document |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. No clinical test set is described for evaluating hair growth performance.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set is described with expert-established ground truth for hair growth.
4. Adjudication method for the test set
- Not applicable. No clinical test set is described.
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 as the device is an infrared lamp for hair growth, not an AI-based diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The "Hair Up" is a physical device (infrared lamp), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for hair growth performance. The non-clinical tests mentioned (wavelength, power, safety, EMC, biological evaluation) would have their own defined test conditions and standards, but these are not 'ground truth' in the context of clinical efficacy for hair growth.
8. The sample size for the training set
- Not applicable. The device is a physical infrared lamp, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.