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The Candela Vbcam Pulsed Dye Laser is indicated for the following uses in:

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

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, stries and psoriasis. Periorbital wrinkles and the treatment of wrinkles.

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

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

The Vbeam is a 595 nm flash-lamp excited pulsed dye medical laser, controlled by an embedded microprocessor, to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars, stries and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles. The Vbeam laser is used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5, 7, 10 and 3 x 10 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.

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

The provided 510(k) summary for the Candela Vbeam Pulsed Dye Laser System does not contain detailed acceptance criteria for wrinkle reduction or specific study data to prove the device meets such criteria.

The submission primarily focuses on establishing substantial equivalence to predicate devices for a broad range of dermatological and vascular lesions, as well as wrinkles, based on similar intended use and technical specifications (wavelength, power, spot size). While "Treatment of periorbital wrinkles and wrinkles" is listed as an indication for use, the document does not present any clinical study data or performance metrics related to wrinkle reduction that would define acceptance criteria or demonstrate the device's efficacy for this specific indication.

Therefore, many of the requested details about acceptance criteria and a study to prove they are met cannot be extracted from this document for the wrinkle indication.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated for wrinkle reduction. The 510(k) relies on substantial equivalence to predicate devices, implying that if the device is similar to previously cleared devices for wrinkle treatment, it is considered safe and effective without new efficacy criteria being defined or met through a specific study.
• Reported Device Performance: Not reported for wrinkle reduction. The document does not provide efficacy rates, clinical improvement percentages, or any quantitative measures for wrinkle treatment.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as no specific clinical study data for wrinkle reduction is presented in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no specific clinical study data for wrinkle reduction is presented in this document.

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

• Not applicable as no specific clinical study data for wrinkle reduction is presented in this document.

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

• This device is a medical laser system, not an AI-based diagnostic or therapeutic tool that relies on "readers" or "AI assistance." Therefore, an MRMC study is not relevant to its clearance.

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

• This is a standalone medical device (a laser system) and does not involve an algorithm separate from human operation. Its performance is directly tied to the physical output of the laser and the skill of the human operator.

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

• Not applicable as no specific clinical study data for wrinkle reduction is presented in this document. The clearance is based on substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is a laser system, not an AI model that requires a training set of data.

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

• Not applicable. This device is a laser system, not an AI model.

Summary of Device Clearance Information Provided:

The Candela Vbeam Pulsed Dye Laser System received 510(k) clearance (K021180) based on its substantial equivalence to previously marketed devices (Candela Vbeam Pulsed Dye Laser (K013784) and SLS Biophile Ltd NLite (K013461)).

The rationale for equivalence includes:

• Intended Use: Similar (e.g., photocoagulation of benign cutaneous vascular lesions, benign cutaneous lesions, treatment of periorbital wrinkles and wrinkles).
• Operating Principles: Utilizes similar principles (595 nm flash-lamp excited pulsed dye laser).
• Design Aspects: Matches key design aspects, including similar spot size, the same wavelength, and/or the same maximum delivered power as the predicate devices.

The clearance is primarily based on the device conforming to safety standards (Laser Performance Standard 21 CFR 1040, UL 2601 Electrical Safety Standard, EN 60601-1-2) rather than presenting new clinical efficacy data for the wrinkle indication in this specific 510(k) summary.

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