(19 days)
Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.
The provided FDA 510(k) clearance letter for the Veincare Laser System does not contain any information regarding a study specifically proving the device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. It explicitly states: "No clinical studies were considered necessary and performed."
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria from the provided text. The information requested regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all related to clinical or performance studies, which were not conducted for this submission according to the document.
However, I can extract the "performance" parameters defined for the device based on non-clinical testing, which could be considered a form of acceptance criteria for the device's technical specifications.
Based on the provided text, here's what can be inferred about the "performance" as defined by the manufacturer and accepted by the FDA for this 510(k) clearance:
1. Table of Acceptance Criteria (Technical Performance) and Reported Device Performance:
| Acceptance Criteria (Technical) | Reported Device Performance |
|---|---|
| Laser Wavelength | 1470nm |
| Laser Output Power | 0.5 to 15 W |
| Pulse Mode Duration | (0.2 to 800)ms |
| Group Pulse Mode Duration | (0.2 to 800)ms |
| CW Mode | CW (Continuous Wave) |
| Pulse Frequency | 1-500Hz |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document states "No clinical studies were considered necessary and performed." The performance data reported above is based on bench tests (non-clinical testing).
- Data Provenance: Not applicable for clinical data. The non-clinical testing was performed by WONTECH Co., Ltd. in Republic of Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable. No clinical or human-reader studies were conducted where expert ground truth would be established.
4. Adjudication Method for the Test Set:
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. The document explicitly states "No clinical studies were considered necessary and performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a laser device, not an AI algorithm. Its performance is measured by its physical output parameters, not diagnostic accuracy.
7. The Type of Ground Truth Used:
- The "ground truth" for the technical performance parameters (wavelength, power, pulse duration, frequency) was established through bench test measurements against specified physical and electrical engineering standards (e.g., IEC 60601-1, IEC 60825-1).
8. The Sample Size for the Training Set:
- Not applicable. No AI algorithm or machine learning model was developed or trained.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of Device Performance Study (as described in the 510(k) submission):
The "study" proving the device meets the acceptance criteria (in this context, technical specifications) was a series of non-clinical bench tests. These tests were conducted to verify that the device's electrical safety, electromagnetic compatibility, and laser output parameters (wavelength, power, pulse duration, frequency) complied with relevant international standards (e.g., IEC 60601-1, IEC 60825-1). The software was also validated as a "MODERATE level of concern" software. The biocompatibility of the optical fiber component was addressed by referencing prior 510(k) clearances for the fiber itself.
No clinical studies involving human subjects were performed or deemed necessary for this 510(k) clearance. The substantial equivalence was demonstrated based on the similarity of the device's technological characteristics and intended use to an existing predicate device, backed by non-clinical performance and safety testing.
§ 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.