(510 days)
The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.
The Cynosure Cellulaze laser is an Nd: Y AG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is housed within a cannula and is combined with the temperature monitoring guide functioning as a safety feature that prevents the laser from generating temperature above the safety range.
Here's a breakdown of the acceptance criteria and study information for the Cynosure Cellulaze Laser, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Endpoint 1: Blinded Identification of Baseline Photographs | |
| At least 80% of photographs correctly identified as baseline by blinded evaluators. | Endpoint 1: Blinded Identification of Baseline Photographs |
| Range for the 3 evaluators was 91-95% correctly identified, which exceeded the predetermined success criteria. | |
| Endpoint 2: Improvement in Cellulite Appearance | |
| 80% of the sites showing a pre-specified improvement on a validated scale (assessed by blinded evaluators of pre and post-treatment photographs). | Endpoint 2: Improvement in Cellulite Appearance |
| Blinded evaluation showed 91% of sites meeting this requirement, which exceeded the predetermined success criteria. |
Study Details
-
Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 57 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). However, it was a "clinical study" that enrolled subjects, implying a prospective and controlled environment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 3 blinded evaluators were used for Endpoint 1 (identification of baseline photographs) and Endpoint 2 (improvement in cellulite appearance).
- Qualifications of Experts: Not specified. They are referred to as "blinded evaluators."
-
Adjudication method for the test set:
- The text describes "3 evaluators" for Endpoint 1, with a "range for the 3 evaluators" provided. This suggests independent evaluation by each expert, and their individual results were reported. There is no explicit mention of an adjudication method (like 2+1 or 3+1) to reach a consensus if disagreements arose. It appears each expert's performance was noted.
-
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:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study assesses the device's standalone performance in improving the appearance of cellulite, not its role as an AI assistant to human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Cynosure Cellulaze Laser. The "blinded evaluators" are assessing the effect of the device on subjects, not the performance of an algorithm. However, the device itself (the laser system) is performing the intervention, with human evaluators assessing the outcome of that intervention. If we interpret "standalone" as the device's efficacy without human intervention in the therapeutic process, then yes. If it refers to an AI algorithm, then no, this is a physical device study.
-
The type of ground truth used:
- The ground truth for Efficacy Endpoint 1 (identification of baseline photographs) is directly tied to the actual baseline photographs. The evaluators' task was to correctly identify these.
- The ground truth for Efficacy Endpoint 2 (improvement in cellulite appearance) was based on expert evaluation/consensus using a "validated scale." The "pre-specified improvement on a validated scale" by blinded evaluators served as the ground truth for success in this endpoint.
-
The sample size for the training set:
- The provided text does not mention a "training set" in the context of an algorithm. The 57 subjects are part of the clinical study to support the efficacy of the device performing the intervention.
-
How the ground truth for the training set was established:
- Not applicable, as no training set for an algorithm is mentioned. The study is a clinical trial evaluating a physical medical 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.