(166 days)
The AC applicator indicated for the treatment of moderate inflammatory acne vulgaries.
The AC applicator is a device that is used for the treatment of moderate inflammatory acne vulgaries. The AC applicator treatment is based on the principle of selective (electromagnetic) thermolysis combined with photochemical reaction of the acne bacteria. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage acne bacteria and the sebaceous glands without damaging the surrounding tissues.
The provided text is a 510(k) summary for the Syneron Medical Ltd. AC applicator, which is a device intended for the treatment of moderate inflammatory acne vulgaris. This document focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for new technologies.
As such, the information required to populate the requested table and answer the study-related questions is not present in the provided text. The document primarily identifies the device, its intended use, predicate devices, and asserts substantial equivalence based on overall performance characteristics without detailing how that performance was measured or what specific criteria it met.
Here's a breakdown of what can be inferred from the document and what cannot be provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document states "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit." However, no specific performance metrics or acceptance thresholds are presented. | Not specified in the provided document. The document does not provide quantitative results from a study demonstrating the device's performance against any set criteria. It only states that no significant differences exist compared to predicate devices, implying similar performance without quantifying it. |
Missing Information for a Performance Study:
Since this is a 510(k) summary focused on substantial equivalence, it does not typically include the detailed clinical study information that would answer questions 2 through 9.
2. Sample Size for the Test Set and Data Provenance:
- Not provided. No details on a clinical test set are present.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not provided. No ground truth establishment is described for a test set.
4. Adjudication Method for the Test Set:
- Not provided. No adjudication method is mentioned as there is no described test set evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document does not describe an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
- Not applicable. This is a physical medical device (AC applicator), not an AI algorithm, so the concept of "standalone algorithm performance" does not apply in this context.
7. The Type of Ground Truth Used:
- Not provided. No ground truth is described.
8. The Sample Size for the Training Set:
- Not provided. This document does not describe a training set.
9. How the Ground Truth for the Training Set was Established:
- Not provided. No training set ground truth establishment is described.
Summary:
The provided document (K032514) is a 510(k) summary, which is a premarket submission to FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. The core purpose of this type of submission is not to prove the device meets specific performance criteria through a detailed clinical study with acceptance thresholds, but rather to show it's as safe and effective as existing devices. Therefore, the detailed information about acceptance criteria, study methodologies, and performance results requested are generally not found in a 510(k) summary.
§ 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.