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The CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is indicated as an accessory for use with the CoolTouch "Varia" Nd:YAG Laser System, which has been cleared for the following indications: Hair removal (destruction of hair follicles) in all skin types and for soft tissue hemostasis of vascular lesions. For pigmented lesions appropriate for 1 or more treatments that would potentially benefit from aggressive to reduce lesion size, for patients that have not responded to other laser treatments.

The fiber optic handpiece used with the CoolTouch Varia laser system has had a fixed spot size. The user selects a 4mm, 6mm, or 8mm spot size, depending on the application. The VariZoom handpiece combines the various spot size handpieces into one, allowing the user to dial the desired spot size instead of changing handpieces. The VariZoom handpiece has the same coolant capability and incorporates a sensor to alert the user that the coolant is depleted.

The provided text describes a 510(k) premarket notification for a medical device, the CoolTouch "VariZoom" Variable Spot Size Reusable Fiber Optic Handpiece. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than extensive de novo clinical studies with acceptance criteria.

Therefore, the information regarding acceptance criteria, study details, and performance metrics as typically found in a clinical trial report with specific quantitative outcomes is not present in this document. The submission focuses on comparing the new device's specifications and intended use to a previously cleared predicate device.

Here's an analysis based on the information provided, highlighting the absence of typical clinical study data:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or reported device performance in the manner of a clinical study with quantitative outcomes. The "performance" is implicitly demonstrated through the comparison of specifications to the predicate device.

2. Sample size used for the test set and the data provenance

No test set data from actual device usage is presented. The submission relies on comparison to a predicate device's established performance and specifications. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a test set is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no test set requiring expert ground truthing as this was primarily a technical and functional equivalence submission.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was performed.

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 fiber optic handpiece for a laser system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

The "ground truth" equivalent in this submission is the established safety and effectiveness profile of the predicate device, the CoolTouch "Varia" Nd:YAG Laser System and its fixed spot size handpieces, as cleared by previous 510(k) submissions. The new device is deemed substantially equivalent based on its similar design, materials, and intended use as an accessory, with the primary difference being a variable spot size mechanism.

8. The sample size for the training set

Not applicable. This is not a machine learning device or algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

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