(88 days)
The Candela Cbeam Pulse 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, hemangioma, 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 Cbeam is a 585 nm flash-lamp excited pulse 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. striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles. The Cbeam laser 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 handpiece, which produces circular beams with diameters of 5, 7 or 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 Cbeam Pulse 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 text describes the Candela Cbeam Pulse Dye Laser System and its clearance via a 510(k) premarket notification. However, it does not contain information regarding a study with specific acceptance criteria and reported device performance in the format requested.
The document primarily focuses on:
- Device Description: What the Cbeam laser is, its operating principles, and its intended uses.
- Predicate Devices: Identification of similar devices already on the market (Candela Clearbeam Pulse Dye Laser (K013043) and SLS Biophile Ltd NLite (K013461)).
- Regulatory Compliance: Mention of adherence to laser performance standards (21 CFR 1040), electrical safety standards (UL 2601, EN 60601-1-2), and demonstrating substantial equivalence to predicate devices.
- Indications for Use: Specific clinical applications approved for the device.
Key takeaway: The submission for this 510(k) relies on demonstrating "substantial equivalence" to existing legally marketed devices rather than presenting a performance study with specific acceptance criteria as you've outlined. The FDA's decision letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met its acceptance criteria by being similar enough to already approved devices, not by achieving specific performance metrics in a new clinical study.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, experts, or adjudication methods based on the provided text, as this type of detailed performance study information is not included in this 510(k) submission.
Summary of missing information based on your request:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific performance criteria from a new study.
- Sample size used for the test set and the data provenance: Not provided, as no such test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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/not provided. This is a laser system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is a physical medical device.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not applicable/not provided, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable/not provided.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.