(279 days)
The MEP-90 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Medically prescribed use for the treatment of androgenic alopecia in females: The treatment of androgenic alopecia in females by promoting hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.
The MEP-90 is a stationary low-level laser device that promotes hair growth and provides treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The MEP-90 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+.76%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.
The MEP-90 Hair Growth Stimulation System, identified by 510(k) number K091496, is indicated for the treatment of androgenic alopecia in females with specific Ludwig and Savin Hair Loss Scale classifications (I to II) and Fitzpatrick Skin Typing (I to IV), by promoting hair growth.
Here's an analysis of the provided information regarding acceptance criteria and the study that supports it:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined "acceptance criteria" as a set of quantified thresholds that needed to be met for device approval. Instead, it describes "therapeutic results standards" and "statistical significance." However, based on the performance data presented, we can infer the device's efficacy targets related to hair count increase and stabilization of hair loss.
| Acceptance Criteria (Inferred from Study Results) | Reported Device Performance |
|---|---|
| Increased Hair Count | |
| After 20 treatments (10-Weeks): | |
| - Percentage of subjects with ≥10% increase in hair count | 92% of subjects demonstrated an increased hair count of ≥10%. |
| - Percentage of subjects with ≥30% increase in hair count | 57% of subjects demonstrated an increase of ≥30%. |
| After 36 treatments (18-Weeks): | |
| - Percentage of subjects with ≥20% increase in hair count | 97% of the subject population demonstrated an increased hair count of ≥20%. |
| - Percentage of subjects with ≥30% increase in hair count | 89% of all subjects demonstrated an increased hair count of ≥30%. |
| - Percentage of subjects with ≥50% increase in hair count | 57% of all subjects demonstrated an increased hair count of ≥50%. |
| Stabilization of Hair Loss | |
| After 20 treatments (10-Weeks): | |
| - Percentage of subjects with medically significant stabilization of hair loss | 98% of subjects indicated a medically significant stabilization of their rate of hair loss. |
| Overall Perception | |
| After 36 treatments (18-Weeks): | |
| - Percentage of subjects feeling treatments helped their condition | 87% of subjects indicated the treatments have helped their condition. |
| - Percentage of subjects reporting further slowed loss rate (from 10-week period) | 60% reported their loss rate has further slowed down from the 10-week period. |
| - Percentage of subjects reporting smaller visible bald spot | 65% reported their visible area of the alopecia (bald spot) had gotten smaller. |
| Adverse Events | No subject experienced any adverse event and/or effect from the treatments. |
| Trend of Hair Growth | 100% of the linear trend plotting for all subjects of their Initial, 10-Week, and 18-Week hair counts demonstrated a historical rate of increased hair growth. The clinical data acquired confirms both the safety and effectiveness of the MEP-90... The data demonstrates clear statistical significance of the treatment results obtained and provide mathematical certainty that the results attained did not occur by chance. (This suggests the primary "acceptance criterion" was statistically significant improvement compared to baseline, rather than necessarily performing better than a comparator device or a predefined threshold for superiority, given it's a 510(k) where substantial equivalence is the goal) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: While the exact number of subjects for the study is not explicitly stated, the document consistently refers to "subjects" and "subject population" in singular. However, given the percentages mentioned (e.g., 92% of subjects, 57% demonstrating an increase), it implies a reasonable number of participants to make these percentages meaningful, suitable for statistical analysis. It is described as a "multi-phased experimental study."
- Data Provenance: The study was "performed with Institutional Review Board (IRB) preapproval and oversight, in accordance with all applicable references of the Food and Drug Cosmetic Act and Title 21; Code of Federal Regulations." This indicates a prospective clinical study designed to evaluate the device. The country of origin for the data is implicitly the USA, given the FDA submission and compliance with US regulations.
3. Number of Experts and Qualifications for Ground Truth
The document pertains to a clinical efficacy study for a medical device that promotes hair growth. The "ground truth" here is the actual biological response to the treatment, measured by hair count and observed changes in alopecia. This is a direct physiological outcome rather than an interpretation task requiring expert consensus on images.
- Number of Experts: Not applicable in the traditional sense of image review or diagnosis confirmation. The "ground truth" is established by direct measurement of hair count and self-reported patient perceptions.
- Qualifications of Experts: The study indicates that "Androgenic alopecia in women is a chronic medical condition requiring diagnosis, treatment, and monitoring by a licensed medical physician." This implies that initial diagnosis and potentially evaluations were performed by licensed medical professionals, but this isn't explicitly described as an "expert consensus" process for establishing ground truth within the efficacy measurements themselves.
4. Adjudication Method for the Test Set
Not applicable. The study measures objective physiological changes (hair count) and subjective patient reports. There's no indication of a diagnostic "test set" requiring adjudication by multiple experts in the context of image interpretation or complex diagnostic calls. The data likely comes from direct clinical measurements and patient questionnaires.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study typically evaluates diagnostic performance (e.g., radiologists reading images) with and without AI assistance. The MEP-90 study is a direct clinical efficacy study of a therapeutic device designed to stimulate hair growth.
6. Standalone (Algorithm Only) Performance
Yes, a standalone study was done in the sense that the clinical efficacy described is the algorithm (device) only performance, without human-in-the-loop assistance for diagnosis or treatment application. The device, the MEP-90 Hair Growth Stimulation System, is a standalone therapeutic device that applies laser light. The study directly measures its effectiveness in promoting hair growth in human subjects when used as prescribed.
7. Type of Ground Truth Used for the Test Set
The ground truth used for the test set was a combination of:
- Objective Biophysical Measurements: Hair count increases at specified intervals (10-weeks and 18-weeks) compared to baseline. The report mentions "linear trend plotting for all subjects of their Initial, 10-Week, and 18-Week hair counts," confirming direct measurement.
- Patient-Reported Outcomes/Observations: Self-reported stabilization of hair loss, perception of treatment effectiveness, slowed loss rate, and reduction in the visible area of alopecia (bald spot).
8. Sample Size for the Training Set
The document describes a single "multi-phased experimental study" conducted on human subjects to determine the efficacy of the MEP-90. There is no mention of a separate "training set" in the context of machine learning. The clinical study is the evaluation of the device's performance, not the training of an AI algorithm on data for later validation. Therefore, this concept is not applicable here as the device itself is a physical light therapy system, not an AI diagnostic tool.
9. How the Ground Truth for the Training Set was Established
As mentioned above, there is no "training set" in the context of an AI algorithm. The MEP-90 is a physical device, and its design and parameters (like wavelength, power output, treatment duration) are based on the established scientific understanding of biostimulation and predicate devices, rather than being "trained" on a dataset in a machine learning sense. The clinical study was to confirm the efficacy and safety of the already designed device.
§ 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.