(145 days)
The Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.
The Smoothbeam Laser is comprised of the following main components:
- a laser system console (including software and control electronics)
- a control and display panel
- a fiberoptic-coupled handpiece
- a skin cooling device integrated into the laser (cryogen is delivered via a hose to a nozzle in the handpiece)
- a safety interlock system
The provided text describes a 510(k) summary for the Candela Smoothbeam Laser System. However, it does not include detailed acceptance criteria or a specific study that quantifies device performance against those criteria in the typical format requested.
The document primarily focuses on establishing substantial equivalence to a predicate device and states that a clinical study was performed, but it lacks the granular details required to fully address your request in the structured format.
Here's an analysis of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. It only states: "A clinical study was performed that produced results that indicate that the Smoothbeam Laser System is effective for the treatment of Atrophic Acne Scars." and "The Smoothbeam Laser is effective for the treatment of Atrophic Acne Scars."
Therefore, a table cannot be constructed with specific numeric acceptance criteria and reported performance values.
2. 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. The document only mentions "A clinical study was performed."
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: Not specified, but clinical studies for 510(k) clearances are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified. The document does not detail how the results of the clinical study were assessed or who assessed them.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified.
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. This device is a laser system, not an AI-powered diagnostic imaging tool that would involve human readers interpreting images with or without AI assistance. The study described is a clinical effectiveness study for a therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a therapeutic laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The implied "ground truth" would be clinical improvement in "Atrophic Acne Scars" as assessed in a clinical study. However, the specific methodology (e.g., physician global assessment, patient-reported outcomes, objective scoring systems) is not described in detail. It would fall under "outcomes data" but further specifics are missing.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not a machine learning algorithm.
Summary of available information:
The available text primarily focuses on the device's intended use, its substantial equivalence to a predicate device, and the general statement that a clinical study was performed demonstrating its effectiveness for treating Atrophic Acne Scars. It lacks the detailed methodological information, specific acceptance criteria, and performance metrics typically found when describing studies for diagnostic algorithms or more complex medical devices.
§ 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.