(118 days)
SHASER V-MINI 2 is intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser V-MINI 2 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.
Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
The provided text describes the Shaser V-MINI 2 Hair Removal System. The study conducted to support its clearance was focused on label comprehension and usability, not on the effectiveness of hair removal itself, which is typically established through clinical trials measuring hair reduction. Since the submission is for substantial equivalence to predicate devices, the hair removal efficacy data from prior submissions for similar devices are likely referenced.
Here's an analysis based on the provided input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for this submission) | Reported Device Performance |
|---|---|
| Label Comprehension: Consumers' ability to understand instructions for safe and appropriate use. | "Sufficient label comprehension" |
| Usability: Consumers' ability to use the device safely in a simulated OTC home-use environment. | "Safe and appropriate use of the device" |
Note: The provided submission focuses on the safety and usability of the device for over-the-counter use, especially regarding label comprehension. It does not provide specific quantitative acceptance criteria (e.g., minimum percentage of users understanding instructions) or detailed performance metrics relating to hair removal efficacy. The statement "The V-MINI 2 is a safe and effective device for the intended use" is a conclusion, not a performance metric from the described clinical tests. The efficacy claims (e.g., "permanent reduction in unwanted hair") rely on the substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Label Comprehension Test Set Sample Size: 150 subjects
- Usability Test Set Sample Size: 123 subjects
- Data Provenance: The document does not explicitly state the country of origin but implies the study was conducted to support FDA clearance in the United States. The studies appear to be prospective as they involved testing subjects' comprehension and usability. The populations included "low literacy subjects."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of study. The ground truth for label comprehension and usability is typically established by observing user behavior and understanding, not by expert consensus on a medical diagnosis or outcome. The evaluation would be done by study administrators observing and recording participant responses and actions.
4. Adjudication Method for the Test Set
Not specified or applicable in the traditional sense for these types of studies. Label comprehension and usability studies typically involve direct observation and structured questionnaires, where participant responses are recorded and analyzed. There's no mention of multiple reviewers adjudicating conflicting interpretations from the subjects.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Shaser V-MINI 2 is a hair removal device, and the described clinical performance data relates to label comprehension and usability, not diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "clinical performance data" for this submission are focused on the human interface with the device (label comprehension and usability) rather than the standalone performance of a complex algorithm or diagnostic output. The device itself (the Shaser V-MINI 2 Hair Removal System) operates independently, and the tests assessed how effectively users could operate it alone based on instructions. The device's "standalone performance" in terms of hair removal efficacy is implicitly handled by its substantial equivalence to predicate devices, where such efficacy data would have been established.
7. The Type of Ground Truth Used
- For Label Comprehension: User understanding and correct verbalization/demonstration of instructions.
- For Usability: Safe and appropriate physical interaction with the device as observed and assessed against predetermined safe/correct usage criteria.
8. The Sample Size for the Training Set
Not applicable. The described studies are for testing the device's usability and label comprehension. This is not an AI/algorithm development and validation study requiring a specific training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of this usability and label comprehension study for a physical device.
§ 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.