(161 days)
The SHASER HRS3 hair removal system is an over the counter device intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Over-The-Counter, Cordless, Rechargable, Personal Light-Based Hair Removal System For Permanent Hair Reduction. Emission activation is by fingerswitch. Includes limited life treatment head and battery charger. Overall weight of the device is 0.45 Kg, and the size is 2.1 x 0.6 x 0.8 cm (HxWxD). Charger Electrical Requirement is 115 VAC, 15A, 50-60 Hz, single phase.
This document describes a 510(k) submission for the Shaser V-MINI Hair Removal System. The information provided is primarily focused on the device's substantial equivalence to a predicate device and its intended use, rather than a detailed clinical study demonstrating its performance against specific acceptance criteria.
Therefore, many of the requested sections about clinical study details cannot be fully answered from the provided text.
Here is the information that can be extracted or reasonably inferred from the document regarding acceptance criteria and related studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of specific performance acceptance criteria for hair reduction or removal efficacy. Instead, it focuses on qualitative assessments related to label comprehension and usability for safe operation.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Label Comprehension | Sufficient understanding of Instructions For Use (IFU) by consumers, including low-literacy subjects. | "The results of the two tests confirms sufficient label comprehension" |
| Usability | Safe and appropriate use of the device by consumers, including low-literacy subjects, in a simulated OTC home-use environment. | "and safe and appropriate use of the device." |
| Functionality/Safety | The device performs as intended without unexpected issues in the test environment. | Confirmed by usability test; no adverse events or functionality issues reported in the summary. |
Note: The primary "performance" claims for this device are "removal of unwanted hair" and "permanent reduction in unwanted hair" (defined as long-term stable reduction at 6, 9, and 12 months post-treatment). However, the provided document DOES NOT contain clinical data or acceptance criteria specifically measuring hair reduction efficacy. The "study" mentioned pertains to label comprehension and usability, not clinical effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for Label Comprehension Test: 150 study subjects
- Sample size for Usability Test: 123 study subjects
- Data Provenance: The document does not explicitly state the country of origin. Given the company (Shaser, Inc.) and the submission to the FDA, it is highly likely that the study was conducted in the United States. The study was prospective in nature, as it involved subjects actively participating in tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the studies described. The studies were focused on consumer comprehension and usability, not on expert assessment of device efficacy against a ground truth (like pathology for disease). The "ground truth" for these studies would be whether the subjects correctly understood the label and could safely operate the device, as assessed by study administrators/observers, rather than independent experts establishing a medical ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For label comprehension and usability tests, the outcome is typically determined by structured observations, questionnaires, and task completion metrics, and there isn't usually a need for a separate adjudication panel in the way medical imaging studies use them.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The described studies are label comprehension and usability tests, not clinical efficacy trials involving human readers assessing outcomes. The device is a direct-to-consumer hair removal system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical hair removal system, not an algorithm. The "standalone" performance here would refer to its physical function and safety, which was assessed through the usability test involving human interaction.
7. The Type of Ground Truth Used
For the label comprehension and usability tests, the "ground truth" was established by the study protocol's definition of correct understanding and safe/appropriate usage. This would typically involve:
- For Label Comprehension: Correct answers to questions about the instructions for use.
- For Usability: Successful and safe completion of tasks with the device according to predefined criteria, observed by study personnel.
There was no "expert consensus," "pathology," or "outcomes data" in the medical sense used to establish ground truth for these specific tests.
8. The Sample Size for the Training Set
This concept is not applicable here. The described studies are consumer-facing validation tests for label comprehension and usability, not a development of an algorithm that requires a training set. The device itself is electro-optical, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there was no "training set" in the context of algorithm development.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.