(291 days)
The Candela Smoothbeam Laser System is indicated for use for the treatment of back acne.
The Diode laser is a diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of back acne. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides multiple bursts 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 operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
The Candela Smoothbeam Laser System (K014128) is indicated for the treatment of back acne. The provided documents describe that "Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of back acne." However, the documents do not provide specific acceptance criteria or detailed study results (such as metrics, sample sizes, or ground truth establishment) to demonstrate how the device meets these criteria.
Therefore, I cannot populate the requested table or answer most of the questions fully based on the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | "effective in the treatment of back acne" |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). While clinical trials are mentioned, details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a laser system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a laser system, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not specified. For a treatment device, this would likely involve clinical outcomes, but the specific methodology is not described.
8. The sample size for the training set:
- Training set sample size: Not applicable and not provided. The device is a physical laser system, not a machine learning model that requires a training set in the conventional sense. The "clinical trials" mentioned would be for evaluating the device's efficacy, not for training it.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable and not provided, as this is a physical device, not an AI model.
In summary, the provided documents indicate that clinical trials were performed and "produced results that the Smoothbeam Laser System is effective in the treatment of back acne." However, no specific details about the methodology, acceptance criteria, sample sizes, or ground truth establishment for these clinical trials are included within the given text.
§ 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.