(84 days)
The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
The Hair Growth Device LS-D601 is composed of 26 3R class laser diodes (wavelength: 650-660nm, power
The provided text does not describe a study that proves the device meets specific acceptance criteria related to its performance in promoting hair growth.
The document is a 510(k) premarket notification for a "Hair Growth Device" (Model LS-D601) and focuses on establishing substantial equivalence to existing predicate devices. It primarily details non-clinical testing for safety and electrical characteristics, along with a usability study, to demonstrate that the device is as safe and effective as previously cleared devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for hair growth efficacy, nor can I answer questions about sample size for a test set, expert involvement in ground truth establishment, MRMC studies, or standalone algorithm performance, as these relate to a clinical performance study that is not detailed in this document.
Here's what can be extracted from the document regarding the information requested:
1. A table of acceptance criteria and the reported device performance:
This document does not provide acceptance criteria or performance data related to the efficacy of hair growth. The "performance" mentioned refers to non-clinical tests demonstrating safety and electrical conformity.
| Acceptance Criteria (Not related to Efficacy) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - In vitro cytotoxicity | Passed |
| - Skin sensitization | Passed |
| - Skin irritation | Passed |
| Electrical Safety & Electromagnetic Compatibility: | |
| - Conformance to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (General requirements for basic safety and essential performance) | Conformed |
| - Conformance to IEC 60601-1-2:2014 (EMC) | Conformed |
| - Conformance to IEC 60601-1-11:2015 (Home healthcare environment) | Conformed |
| - Conformance to IEC 60601-2-57:2011 (Medical electrical equipment) | Conformed |
| - Conformance to IEC 60825-1:2007 (Safety of laser products) | Conformed |
| Software Verification and Validation: | |
| - All software requirement specifications met | Demonstrated that all software requirement specifications are met |
| - All software hazards mitigated to acceptable risk levels | Demonstrated that all software hazards have been mitigated to acceptable risk levels |
| Usability: | |
| - Participants able to understand user manual and box labeling | Testing showed participants were able to understand |
| - Participants able to safely and effectively use the device | Testing showed participants were able to safely and effectively use the device |
Questions that cannot be answered from the provided text as they pertain to clinical efficacy studies:
- 2. Sample size used for the test set and the data provenance: Not applicable, no clinical efficacy test set described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical efficacy test set described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical efficacy test set 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: Not applicable. This document is for a physical device, not an AI model, and no MRMC study for efficacy is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical device, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical efficacy test set described.
- 8. The sample size for the training set: Not applicable, no training set for a machine learning model is described for efficacy.
- 9. How the ground truth for the training set was established: Not applicable, no training set for a machine learning model is described for efficacy.
Summary of what the document does convey about "proving the device meets acceptance criteria":
The document demonstrates that the "Hair Growth Device" meets safety and electrical performance standards, as well as usability requirements, through non-clinical testing. This supports its substantial equivalence to predicate devices, allowing it to be legally marketed. However, it does not provide evidence of new clinical studies to prove its efficacy in promoting hair growth, but rather relies on the established efficacy of the predicate devices based on similar technology and intended use.
§ 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.