(209 days)
The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.
The Theradome LH80 PRO for men and women is a low level coherent light therapy (LLLT) device utilised to promote hair growth. The coherent lights are contained inside a lightweight, one-size fits all helmet. The Theradome LH80 PRO uses 80 coherent light diodes in the helmet to deliver coherent light stimulation to the entire scalp for hands-free operation during treatment. An audible timer automatically turns the coherent lights off after the 20 minutes treatment is completed. This coherent light helmet is not constructed to be a safety helmet.
The provided text describes the Theradome LH80 PRO device and its FDA submission (K171775). While it states that "all acceptance criteria were met by the devices," and refers to compliance with IEC-60825-2007-03, it does not explicitly list specific acceptance criteria or present the full details of a study with performance metrics in a way that allows for a direct table comparing acceptance criteria to reported device performance.
Instead, the document primarily focuses on establishing "substantial equivalence" to predicate devices based on similar technological characteristics and intended use. It explicitly states "Brief Description of Clinical Testing: Not applicable." This indicates that a clinical study designed to test efficacy against specific hair growth metrics was not performed for this 510(k) submission.
Therefore, many sections of your request cannot be fully answered from the provided text. I will answer what is available and indicate when information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the devices." It also notes compliance with standard IEC-60825-2007-03, which establishes the AEL (accessible emission limits) as 5 milliwatts maximum. However, specific, measurable "acceptance criteria" related to efficacy (e.g., percentage increase in hair count, reduction in hair loss rate) and corresponding reported performance from a specific study are not provided in this document. The focus is on safety and technical specifications, and substantial equivalence to a predicate.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Compliance with design specifications | All functions verified to operate as designed. | General statement, specific metrics not detailed. |
| Compliance with IEC-60825-2007-03 (Coherent Light Class 3R) | AEL (accessible emission limits) meets 5 milliwatts maximum. | This is a safety standard, not an efficacy criterion. |
| Usability for self-selection | Verified. | Details of "verification" are not provided. |
| Comprehension of user instructions | Verified. | Details of "verification" are not provided. |
| Comprehension of warnings | Verified. | Details of "verification" are not provided. |
| Comprehension of precautions | Verified. | Details of "verification" are not provided. |
| Efficacy-related metrics (e.g., hair count) | Not provided in this document for the K171775 submission. | The submission relies on substantial equivalence and does not report on clinical efficacy trials for this specific submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not applicable for clinical performance as "Clinical Testing: Not applicable" is stated. For the "self-selection and usability" tests, the sample size is not mentioned.
- Data provenance: Not specified for the usability tests. For the technical compliance, it's typically internal testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable as clinical efficacy studies with ground truth established by experts are explicitly stated as "Not applicable" for this submission (K171775). For usability, no information on experts is provided.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical efficacy test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document states "Brief Description of Clinical Testing: Not applicable."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The Theradome LH80 PRO is a low-level light therapy device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the technical performance and safety aspects, the ground truth is established by adherence to recognized standards (e.g., IEC-60825-2007-03) and design specifications.
- For usability and self-selection, the ground truth would typically be user feedback or observation, but specific details are not provided.
- For clinical efficacy (e.g., hair growth), no ground truth data from a clinical study is included in this submission.
8. The Sample Size for the Training Set
- Not applicable, as this is a medical device for light therapy, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is not an AI/ML algorithm.
§ 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.