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The Candela Vbeam Pulse Dye Laser System is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesions, such as warts, scars, striae, and psoriasis. Treatment of periocular wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

The Vbeam Pulse Dye laser is a 595 nm, flash lamp excited pulsed dye medical laser, controlled by an embedded microprocessor. The Vbeam Pulse Dye Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular or elliptical laser beams onto the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.

The Candela Vbeam Pulse Dye Laser is equipped with a safety interlock system to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

This document describes the Candela Vbeam Pulse Dye Laser System, a medical device for the photocoagulation of benign cutaneous lesions and vascular lesions. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory purposes.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The provided document does not list specific acceptance criteria as quantitative thresholds that the device must meet (e.g., "device must achieve X accuracy"). Instead, the "acceptance criteria" are implicitly understood as demonstrating substantial equivalence to predicate devices. The "device performance" is described in terms of its characteristics and intended use being similar to these predicates.

Study Details

The provided document does not describe a clinical study or performance study in the way you've outlined. Instead, it's a 510(k) premarket notification for demonstrating substantial equivalence based on technical and intended use comparisons to existing predicate devices. Consequently, many of your requested details are not applicable or available in this type of submission.

Here’s a breakdown based on the provided text:

1. Sample size used for the test set and the data provenance:

   • N/A. No clinical "test set" and associated data provenance (e.g., country of origin, retrospective/prospective) are mentioned. The submission relies on comparative analysis with predicate devices and compliance with engineering standards.

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

   • N/A. No clinical "test set" requiring expert-established ground truth is described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No clinical "test set" requiring an adjudication method is described.

4. 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. This device is a laser system, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance." Therefore, an MRMC study is not applicable.

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

   • N/A. This is a hardware laser system with software controls, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • N/A. Since no clinical performance study for the Vbeam Pulse Dye Laser System itself is detailed, there's no mention of ground truth establishment for a test set. The "ground truth" in this context is the established safety and efficacy of the predicate devices to which the Vbeam is compared.

7. The sample size for the training set:

   • N/A. No "training set" for an algorithm or AI model is applicable to this device type or submission.

8. How the ground truth for the training set was established:

   • N/A. See point 7.

In summary, the provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Candela Vbeam Pulse Dye Laser System to previously cleared predicate devices based on its intended use, operating principles, and design aspects. It does not contain information about a clinical performance study with defined acceptance criteria, test sets, ground truth establishment, or clinical efficacy data as one might find for a novel diagnostic or AI-powered device. The "testing" mentioned refers to compliance with laser performance and electrical safety standards.

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