(195 days)
The Candela Smoothbeam Laser is indicated for the following uses: For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, New indication: Treatment of Sebaceous Hyperplasia
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used in dermatology for the treatment of wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output produces circular beams on the skin. The Dynamic Cooling Device, provides a short burst of 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, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operations. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
The provided document, K041242 for the Candela Smoothbeam Laser System, describes the device and its intended uses, including a new indication for the treatment of sebaceous hyperplasia. However, it does not include detailed information regarding specific acceptance criteria, a clinical study design with performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods for the new indication.
The document primarily focuses on establishing substantial equivalence to a predicate device (Candela Smoothbeam 1450 nm Diode Laser System, K013825, K030834) for the expanded indication. It states: "Published clinical data, using t he predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication, - the treatment of sebaceous hyperplasia." This suggests that the substantial equivalence hinges on existing clinical data from the predicate device rather than a new standalone study for this specific 510(k) submission.
Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text for the new indication of sebaceous hyperplasia. The document states that "Published clinical data, using the predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication." This implies that the acceptance criteria for "safety and effectiveness" for sebaceous hyperplasia were met by the existing data from the predicate device, but the specific quantitative criteria (e.g., percentage reduction in lesion size, number of lesions cleared, etc.) are not detailed.
2. Sample size used for the test set and the data provenance
Not explicitly stated for the sebaceous hyperplasia indication in this document. The document refers to "Published clinical data" from the predicate device, but does not provide details of that specific study, including its sample size or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. Ground truth for the published clinical data of the predicate device is not described in this submission.
4. Adjudication method for the test set
Not explicitly stated. Adjudication method for the published clinical data of the predicate device is not described in this submission.
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. The Candela Smoothbeam Laser System is a physical medical device, not an AI-assisted diagnostic or imaging system involving human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical laser device, not an algorithm.
7. The type of ground truth used
Not explicitly stated for the sebaceous hyperplasia indication. For a laser treatment, ground truth in clinical data would typically involve clinical assessment (e.g., visual grading, photographic assessment of lesions by dermatologists, possibly histology from biopsies if performed). The document only broadly refers to "results that demonstrate that the Smoothbeam Laser is safe and effective."
8. The sample size for the training set
Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in this context. The "training" in this context would refer to physician training on using the laser, which is not what this question is asking.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI system with a machine learning training set.
§ 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.