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The Candela Family of Pulse Dye Laser Systems 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, hemangioma, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles.

Treatment of Inflammatory Acne Vulgaris

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

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

New Indication: Treatment of Benign Epidermal Pigmented Lesions

The Candela Family of Pulse Dye Laser Systems are flash-lamp excited pulsed dye medical lasers, controlled by an embedded microprocessor., to be used for the following uses in: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. For treatment of benign cutaneous vascular lesion, such as facial and leg Dermatology/Plastic Surgery: telangiectasia, rosacea, port wine stains, hemangiomas, angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

New Indication: Treatment of Benign Epidermal Pigmented Lesions

The Lasers may be 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 hand piece. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the hand piece . The Candela Family of Pulsed Dye Laser Systems are 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 text is a 510(k) summary for the Candela Family of Pulsed Dye Laser Systems. It describes the device, its intended uses, and claims substantial equivalence to previously marketed devices. However, it does not contain a study that proves the device meets specific acceptance criteria.

The document states:

• "As a laser product, the Family of Pulsed Dye Laser Systems are required to conform and do conform to the Laser Performance Standard (21 CFR 1040). In addition the lasers conform to the Harmonized Standard EN 60601 1-2, Part 2 established by and required by the European Community." This indicates compliance with general safety and performance standards for laser products, but these are not acceptance criteria tied to a specific clinical performance study for the device's effectiveness for a new indication.
• "The Candela Family of Pulsed Dye Laser Systems is equivalent in key design aspects, functional features and indications for use as the predicate devices for the treatment of epidermal pigmented lesions. On the basis of similarities in functional features, method of operation, and intended uses, Candela Corporation believes that the Candela Family of Pulsed Dye Laser Systems are substantially equivalent to the predicate devices." This is the core of a 510(k) submission: demonstrating substantial equivalence, not necessarily providing new clinical data proving efficacy against specific acceptance criteria.

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance directly from a study. There is no clinical study described that evaluates the device's performance against specific, quantifiable acceptance criteria for its new indication (Treatment of Benign Epidermal Pigmented Lesions) or any other indication. The submission relies on substantial equivalence to predicate devices, implying that the predicates have established safety and effectiveness.

Here's a breakdown of why the requested information cannot be fully provided from the text:

1. Table of acceptance criteria and reported device performance: Not available. The document refers to general laser performance standards (21 CFR 1040, EN 60601 1-2) which are safety and electrical standards, not clinical performance criteria. There is no reported clinical performance data.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set/study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set/study is described.
4. Adjudication method for the test set: Not applicable, as no clinical test set/study is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
7. The type of ground truth used: Not applicable, as no clinical test set/study is described.
8. The sample size for the training set: Not applicable, as no training set for a clinical study is described.
9. How the ground truth for the training set was established: Not applicable, as no training set for a clinical study is described.

In summary, this 510(k) relies on the concept of "substantial equivalence" to predicate devices, rather than presenting a new clinical study with specific acceptance criteria and performance data for the device itself.

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