(176 days)
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins associated with varicose veins and varicosities. Non-Contact mode
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and variosities. Non-Contact mode
ATOVEN Diode laser systems are Laser Surgery Systems that use optical energy radiated from semiconductor laser in order to cure varices. with Wave Length 1,470mm, and consists of CPU, LCD monitor, Cooling Systems, laser controller, Fiber optic pullback device included foot pedal switch. LED monitor are displaying various graphic to shows Operating Parameter, Mode, Time function, system status to user.
The provided text describes a 510(k) premarket notification for a medical device (ATOVEN) and does not contain information about a study proving the device meets specific acceptance criteria.
Instead, it focuses on demonstrating substantial equivalence to a predicate device based on common intended use, function, technology, operational principles, and performance. The document explicitly states: "No clinical standards have been established for Diode Laser, but did Safety and Performance test in accordance with below Standard." followed by a list of non-clinical safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC60825_1).
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I answer questions related to sample sizes, expert qualifications, or comparative effectiveness studies, as these types of studies were not conducted or reported for this submission.
Here's a breakdown of what can be extracted and addressed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical, based on Standards) | Reported Device Performance |
|---|---|
| Safety and Performance Tests conducted in accordance with: | |
| IEC 60601-1 Medical Electrical Equipment part 1 General Requirement for safety amend 2:1995 | Not explicitly detailed, but implied compliance for substantial equivalence. |
| IEC 60601-1-2 Electromagnetic compatibility test ED 2007 | Not explicitly detailed, but implied compliance for substantial equivalence. |
| IEC 60601-1-2-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment | Not explicitly detailed, but implied compliance for substantial equivalence. |
| IEC60825_1 Safety of laser products Part 1, section 2, Manufacturing requirement. | Not explicitly detailed, but implied compliance for substantial equivalence. |
Note: The document only states that these tests were "did" (performed) and that the device is substantially equivalent, implying that it met the requirements of these standards. Specific numerical performance data or pass/fail criteria for each standard are not provided.
Regarding the other requested information:
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission relies on non-clinical safety and performance tests to standards, not a clinical test set with a sample size of patients.
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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 applicable / Not provided. No clinical ground truth was established by experts for performance evaluation as part of this submission. The ground truth for proving safety and performance was adherence to the listed international safety standards.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set or adjudication was performed.
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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 / Not provided. This device is a diode laser system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or reported.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm; it's a medical device (laser system). Its performance is inherent in its design and manufacturing, verified against safety standards.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" was compliance with the specified international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC 60825-1).
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8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.
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9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this question is not relevant.
§ 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.