(85 days)
The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenic alopecia who have Ludwig-Savin Classifications I - II, and for both, with Fitzpatrick Skin Phototypes I- IV.
The Shapiro MD, Model Laser 272 is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack.
This document describes a 510(k) premarket notification for the Shapiro MD, Model Laser 272, a low-level laser therapy (LLLT) device intended to promote hair growth. However, it's crucial to understand that this submission does not involve clinical performance studies or the establishment of ground truth as would be typical for an AI/ML device.
The core of this submission is a claim of substantial equivalence to a previously cleared predicate device (Diode Laser Cap, K173678). This means the manufacturer is asserting their device is so similar to an already approved device that it does not require new clinical data to prove its safety and effectiveness.
Therefore, many of the requested elements for describing "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not applicable to this 510(k) submission. There is no AI/ML component described, and no performance study was conducted to demonstrate efficacy of the new device itself.
Based on the provided text, here's an analysis addressing the requested points where applicable, and explaining why others are not:
1. A table of acceptance criteria and the reported device performance
Since no clinical efficacy study was conducted for this specific device, there are no "acceptance criteria" related to a performance metric like sensitivity, specificity, or accuracy that would be proven through a study. The "acceptance criteria" in this context are the criteria for demonstrating substantial equivalence to the predicate device.
Acceptance Criteria (for Substantial Equivalence):
| Criterion | Shapiro MD, Model Laser 272 | Diode Laser 272 (Predicate) | Result/Performance |
|---|---|---|---|
| LLLT Device Type | Laser Diode | Laser Diode | Identical |
| Use Application | OTC | OTC | Identical |
| Intended Use | Androgenic Alopecia | Androgenic Alopecia | Identical |
| Contains Laser Diodes | 272, 5 milliwatts each | 272, 5 milliwatts each | Identical |
| Physical Design of Device | Helmet | Helmet | Identical |
| Wavelength | 650+/-5 NMS | 650+/-5 NMS | Identical |
| Marketing Clearance | For females and males, OTC | For females and males, OTC | Identical |
| Use Type | Passive Use-Hands Free | Passive Use-Hands Free | Identical |
| Classification Code | OAP | OAP | Identical |
| Classification Name | Infrared Lamp | Infrared Lamp | Identical |
| Common Usage Name | Lamp, Non-Heating | Lamp, Non-Heating | Identical |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery | Identical |
| Skin Phototypes | I- IV | I- IV | Identical |
| Hair Loss Classification | Norwood-Hamilton IIa-V for males; Ludwig-Savin I – II for females | Norwood-Hamilton IIa-V for males; Ludwig-Savin I – II for females | Identical |
| Treatment Regime | 16 weeks, for 30 minute treatment times, three times a week, on alternate days. | 16 weeks, for 30 minute treatment times, three times a week, on alternate days. | Identical |
| Device Class | II | II | Identical |
Reported Device Performance:
The document explicitly states: "No clinical performance data was submitted because the Shapiro MD, Model Laser 272 is the same device as the predicate, the Diode Laser Cap, cleared under KI 73678. The proposed device and predicate devices are IDENTICAL and the same device is offered for PRIVATE LABEL by the manufacturer."
Instead of clinical performance, the reported "performance" for this submission is conformance to consensus international standards:
- IEC 60601-1:2005 + CORR. 1: 2006 + CORR. 2: 2007 + A1: 2012 (Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2: 2014 (Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances-Requirements and Tests)
- ISO 10993-5 2009 (Biological Evaluation of Medical Devices Part 5 Tests for In Vitro Cytotoxicity)
- ISO 10993-10: 2010 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization)
- IEC 60825-1 Edition 2.0 2007 03 (Laser Safety & Classification)
- IEC 62133 (Battery Cells) and IEC60950 (Battery Charger)
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. There was no clinical test set for performance because no clinical study was conducted for this device. The "test set" for substantial equivalence was the comparison of specifications between one instance of the new device and the predicate device's specifications.
- Data provenance: Not applicable for clinical performance. The data provenance for the substantial equivalence claim comes from the technical specifications of the current device and the FDA-cleared predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. No ground truth was established through expert review for clinical performance data, as no such data was generated for this submission. The "ground truth" for the substantial equivalence assertion is the detailed technical specifications of both devices.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. No clinical test set requiring adjudication was used. The substantial equivalence was asserted by the manufacturer and reviewed by the FDA.
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
- MRMC study: No.
- Effect size: Not applicable. This device is not an AI/ML diagnostic tool and does not involve human readers. It is a therapy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device is a direct-to-consumer therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable for a clinical performance study. The "ground truth" for this 510(k) submission's purpose of demonstrating substantial equivalence is the technical specifications and indications for use of the predicate device, as stated in its original 510(k) clearance.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
In summary: The provided document is a 510(k) clearance letter for a medical device (laser hair growth device) based on substantial equivalence to a predicate device, not on new clinical performance data generated by the applicant for this specific submission. Therefore, most of the questions pertaining to testing, ground truth establishment, and AI/ML performance metrics are not relevant to this type of regulatory submission. The "study" proving it meets "acceptance criteria" here is the comparison of its technical characteristics and indications for use against a predicate device, and finding them to be identical.
§ 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.