(51 days)
The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Glide device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Glide device is composed of a hand held applicator. The device contains 6 LEDs indicated 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm . The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.
This document describes the premarket notification for the "Glide Device," a pulsed light hair removal device. The submission primarily relies on substantial equivalence to a previously cleared device rather than on extensive new clinical performance data. Therefore, many of the typical acceptance criteria and study details for AI/software-based devices are not applicable.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria for clinical performance (e.g., hair reduction percentage). Instead, it focuses on demonstrating safety and functional equivalence to a predicate device. The primary "acceptance criteria" are compliance with voluntary recognized standards and successful usability testing.
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Safety - Electrical/Mechanical | IEC 60601-1 (General Safety) | Complies with standard |
| IEC 60601-1-2 (EMC) | Complies with standard | |
| EN 62471 (Photobiological Safety) | Complies with standard | |
| EN 60601-2-57 (Non-laser light source) | Complies with standard | |
| Software Validation | IEC 60601-1-4; FDA Guidance | Software Validation conducted |
| Usability | Safe and effective device use by potential end users under actual use conditions | 100% of 20 enrolled subjects completed all tasks successfully, indicating safe and effective use. |
| Indications for Use (Substantial Equivalence) | Intent to achieve permanent reduction in hair regrowth (6, 9, 12 months post-treatment) equivalent to predicate. | No new clinical data presented. Equivalence based on similar technology and performance specifications to predicate device (Silk'n Flash N Go). |
2. Sample Size Used for the Test Set and Data Provenance
- Usability Study: The test set for the usability study consisted of 20 potential device end users.
- Data Provenance: The study was likely conducted prospectively in a simulated home use environment for the usability assessment. The country of origin is not specified but the applicant is based in Israel.
- Clinical Performance: No specific clinical test set data from the Glide device is provided or used for evaluation as the submission relies on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Usability Study: The document does not mention the use of "experts" to establish a ground truth for the usability study in the traditional sense of clinical experts (e.g., radiologists). The "ground truth" for usability was likely defined by successful completion of tasks by the 20 end users and their subjective feedback through questionnaires.
- Clinical Performance: For clinical performance (hair reduction), no new clinical studies with expert-established ground truth were performed for the Glide device, as the submission relies on substantial equivalence.
4. Adjudication Method for the Test Set
- Usability Study: No explicit adjudication method (like "2+1" or "3+1") is described. The assessment of "successful completion of tasks" for the 20 users appears to have been direct observation and possibly self-reporting via questionnaires.
- Clinical Performance: Not applicable, as no new clinical test set data from the Glide device was presented.
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
- Not Applicable. This device is a pulsed light hair removal device, not an AI or software-assisted diagnostic or interpretative tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device. While it contains software for controlling its functions (like skin color sensing), it's not an "algorithm-only" or AI diagnostic device in the context typically discussed for standalone performance evaluations. The device's safety features (skin sensor, temperature sensor) operate automatically.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Usability Study: The "ground truth" was essentially the observed success of users completing device operation tasks and their qualitative feedback on usability. This is not a clinical ground truth like pathology or outcomes data.
- Clinical Performance: For the intended use of permanent hair reduction, the ground truth would typically be hair count reduction measured at specific time points. However, for the Glide device submission, this outcome data was not specifically collected for this device during the approval process. The claim of achieving permanent hair reduction relies on the substantial equivalence to the predicate device, which presumably demonstrated this through its own studies.
8. The Sample Size for the Training Set
- Not Applicable. This submission does not describe an AI/ML algorithm that requires a "training set" in the conventional sense. The device's software is related to control functions and safety features, which are typically validated through software testing and hardware integration rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no described AI/ML training set, the establishment of ground truth for such a set is not relevant.
In Summary:
The K131870 submission for the Glide Device is a 510(k) premarket notification primarily based on substantial equivalence to an existing predicate device (Silk'n Flash N Go). Therefore, it largely emphasizes demonstrating that the new device shares similar technological characteristics, performance specifications, and safety features with the predicate, and complies with relevant safety standards.
A usability study was conducted with 20 end users to ensure safe and effective operation given minor design changes, and this served as a key performance data point for the new design. However, there were no new clinical trials with specific acceptance criteria for hair reduction performed for this particular submission, nor are there any AI/ML components requiring training sets or MRMC studies.
§ 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.