(266 days)
ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux. for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 mm, a power range 5-15W, using an SMA905 connector.
ATOVEN-Reusable Laser Fiber is free-beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. This device can be connected with SMA905 connector and deliver to 810~1470;m. This device can be connected with cleared surgical use laser diode.
ATOVEN-Reusable Laser Fiber consists of optic fiber. The optic fiber also consists of connector, optical fiber. Fiber cable is made of the optical fiber that delivers the laser beam. And the fiber may be used any laser wavelength between 810~1470 m that have been cleared for surgical use diode laser. Outer diameter of fiber cable is 0.6mm and length is 2900 mm.
The fiber core and cladding for the subject device are made from silica which is the same material used in the predicate device. This device can be connected with SMA905 connector.
This document is a 510(k) summary for the ATOVEN-Reusable Laser Fiber, a medical device used for endovascular coagulation of varicose veins. It doesn't contain the typical acceptance criteria and study design found in a clinical trial for an AI/CADe device. Instead, it details bench tests and biocompatibility tests conducted to demonstrate substantial equivalence to predicate devices.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical performance studies of AI algorithms, which are not relevant to this type of device submission.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests and biocompatibility tests performed. It states "The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device." However, it does not provide specific numerical acceptance criteria or quantitative performance results in a table format. The performance is broadly stated as meeting the standard for substantial equivalence.
Types of Tests Performed (Not acceptance criteria/performance in a table):
| Test Type | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Bench Tests | Radiopacity, flexural strength, drop out, breakdown, appearance, dimension, laser transfer efficiency test, integrity test, fiber transmission angle tip test, simulated clinical environment test, fiber transmission angle test (with glass and without glass), Dimension comparison test. | "The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device." |
| Biocompatibility | Hemolysis, cytotoxicity, intracutaneous reactivity, maximization, pyrogen, and acute systemic toxicity. | "The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document details bench tests and biocompatibility tests, not clinical studies with a test set of patient data. Therefore, information about a "test set" in the context of patient data, sample size for such a set, and data provenance (country, retrospective/prospective) is not applicable and not provided.
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)
This information is not applicable and not provided as there was no clinical test set requiring expert ground truth establishment for an AI/CADe device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the same reason as above.
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
There was no MRMC comparative effectiveness study and thus no effect size for human readers with/without AI assistance, as this is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not an AI algorithm, so no standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth in the context of an AI/CADe device is not applicable. For the physical device, the "ground truth" for the bench and biocompatibility tests would be established by validated measurement standards and laboratory procedures.
8. The sample size for the training set
This is not an AI device, so there is no concept of a "training set" in the machine learning sense. The device is evaluated based on its physical properties and biocompatibility.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI model.
§ 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.