(261 days)
The Candela Smoothbeam Laser System is indicated for the treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used in the Candela Smoothbeam Laser System. The Candela Smoothbeam Laser System is comprised of a laser, delivery system, software control system and Dynamic Cooling Device. The laser energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device functions to cool the skin during the laser treatment by spraying cryogen spray during the laser treatment. The cryogen 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 and reducing pain associated with laser treatment.
The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
The provided text is a 510(k) summary for the Candela Smoothbeam Laser System (K030834). Despite mentioning a "controlled clinical study" for safety and effectiveness, the document does not provide any specific acceptance criteria or detailed results of that study (such as performance metrics, sample sizes, or ground truth methods) that would allow for the completion of the requested table and comprehensive description.
The summary focuses on:
- Substantial equivalence: The primary claim is that the device is identical to a previously cleared predicate device (K022884) in terms of operating principles, materials, mechanism of action, and design.
- Regulatory compliance: Conformance to laser performance standards (21 CFR 1040) and electrical safety standards (UL 2601, EN 60601-1-2) is stated.
- General statement on clinical study: "A controlled clinical study, using a device that has been cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser System is safe and effective for the treatment of mild to moderate inflammatory acne vulgaris."
Therefore, based on the provided text, it is not possible to fill in the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or expert details. The summary simply states that a study was done and confirmed safety and effectiveness, without providing the details required for this request.
Here's what can be extracted and what cannot:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not specified in the document beyond a qualitative statement that "the Smoothbeam Laser System is safe and effective for the treatment of mild to moderate inflammatory acne vulgaris." No quantitative metrics (e.g., percentage improvement, lesion count reduction) are provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (country, retrospective/prospective). While it says a "controlled clinical study" was done, it doesn't offer details about the data used in that study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
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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. This is a laser device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser device, not an algorithm. The "clinical study" would have involved the device's application to patients.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For acne treatment, this might typically involve clinical assessment scores, lesion counts, or patient-reported outcomes, but the document does not elaborate.
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The sample size for the training set: Not applicable/specified. This is not an AI/algorithm-based device in the sense of requiring a "training set." The clinical study evaluated the device's effect directly.
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How the ground truth for the training set was established: Not applicable/specified.
In summary, the provided 510(k) summary is a regulatory filing focused on substantial equivalence and regulatory compliance, not a detailed scientific report of a clinical trial. It does not contain the granular data requested for performance metrics, acceptance criteria, sample sizes, or ground truth establishment.
§ 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.