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1,064nm:

The Vbeam® Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

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, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

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

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

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

The Vbeam Prima Laser System (K183452) is a laser surgical instrument. As stated in section 9, "no clinical studies were needed to support this 510(k) Premarket Notification." Therefore, no specific acceptance criteria or "study that proves the device meets the acceptance criteria" in terms of clinical performance are provided in the document.

The document focuses on demonstrating substantial equivalence to predicate devices (Candela Vbeam Prima Laser System (K180593) and Candela GentleMAX Family of Pulse Dye Laser Systems (K140122)) through non-clinical performance data.

Here's a breakdown of the information requested, based on the provided text:

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

Since no clinical acceptance criteria or performance metrics were reported for this specific 510(k), this table cannot be populated as requested. The document emphasizes equivalence to predicate devices based on:

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

Not applicable, as no clinical human subject test set was used for this 510(k) submission. Performance data primarily comes from engineering and software testing.

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 clinical human subject test set requiring expert ground truth assessment was conducted.

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

Not applicable, as no clinical human subject test set was conducted.

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, as the device is a laser system, not an AI diagnostic tool, and no clinical studies, including MRMC studies, were performed for this submission.

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

Not applicable, as the device is a laser system, not an algorithm.

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

Not applicable, as no clinical studies with a defined ground truth were provided in this 510(k). The "ground truth" for the non-clinical performance data would be adherence to established engineering and software standards.

8. The sample size for the training set

Not applicable, as no machine learning algorithm was evaluated, and therefore no training set was used.

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

Not applicable, as no training set was used.

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1,064nm:

The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

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, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

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

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

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 7-11 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

The Vbeam Prima Laser System's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Since no clinical studies were conducted for the Vbeam Prima Laser System due to its substantial equivalence to predicate devices, there isn't a "test set" in the traditional sense for clinical performance.

• Electrical Safety and EMC: Testing was conducted on the device itself (Epic Pro 940, implicitly the Vbeam Prima or a prototype). This involved laboratory testing, not human subjects or patient data.
• Biocompatibility: Testing was on materials of the device, according to ISO 10993 standards. This is laboratory testing.
• Software Verification & Validation: Testing was on the software of the device. This is internal software testing.
• Bench Testing (Cooling Performance): Testing was on the DCD and Evercool handpieces. This is laboratory testing.

Therefore, there is no human subject data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no clinical studies were performed. The "ground truth" for the device's safety and effectiveness was established by its compliance with recognized standards and its technological similarity to legally marketed predicate devices, which had previously demonstrated safety and effectiveness through their own studies and clinical use.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done, as no clinical studies were performed. The Vbeam Prima Laser System is a physical medical device (laser system), not an AI algorithm that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable, as the Vbeam Prima Laser System is a physical medical device, not an AI algorithm. Its performance is evaluated through engineering and biocompatibility testing, not AI algorithm standalone performance.

7. Type of Ground Truth Used

The "ground truth" for the Vbeam Prima Laser System's safety and effectiveness relies on:

• Compliance with recognized international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
• Demonstrated equivalence of technological characteristics and intended use to predicate devices that have an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical medical device, not an AI algorithm.

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