(135 days)
The Vitra 2 is for use in the treatment of ocular pathology of anterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:
- · Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- · Branch retinal vein occlusion
- · Treatment of choroidal neovascularization associated with wet Age-related macular degeneration
- · Retinal tears and detachments
- · Macular edema
The Vitra 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.Laser energy is delivered to opaque structures within the eye by means of delivery systems including slit lamp, indirect ophthalmoscope, operating microscope and endocular probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. It also includes a Multispot delivery system made by scanner motors which can deliver several spots to the retina in a pattern. The laser energy is delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.
The Quantel Medical VITRA 2 includes a Scanning Laser Delivery System adaptor with scanner controls that may be coupled to a slit lamp. Once activated by the user, the VITRA 2 delivers a predetermined pattern by sequentially scanning the placement of the laser spots and the emission of the individual pulses of laser light. Treatment is initiated by pressing the footswitch and may be aborted by releasing the footswitch.
The provided text is a 510(k) summary for the Quantel Medical Vitra 2 device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Quantel Medical Vitra Multispot).
However, the information requested in your prompt (Acceptance Criteria and a study proving the device meets the criteria, particularly in the context of an AI/ML-driven device) is not present in this document. The Vitra 2 is a laser surgical instrument, and its performance data focuses on compliance with electrical and laser safety standards (IEC 60601 series, IEC 60825-1) and hardware/software validation. There is no mention of AI/ML components, a test set, expert readers, ground truth establishment for a diagnostic algorithm, or MRMC studies.
Therefore, I cannot fulfill your request using the provided text. The requested information pertains to a different type of device evaluation (typically for AI/ML-based diagnostic or prognostic tools) than what is described for the Vitra 2 laser system.
To illustrate, if this were an AI/ML device document, the "Performance Data" section would ideally contain details such as:
- Acceptance Criteria Table: Specific metrics (e.g., accuracy, sensitivity, specificity, AUC) with a pre-defined threshold that the device's performance must meet.
- Study Design: Description of the test set, sample size, data provenance, and how ground truth was established.
- Expert Consensus: Details on the number and qualifications of experts involved in ground truth labeling and any adjudication process.
- MRMC Study: Information on comparative effectiveness studies, if human readers were assisted by the AI.
- Standalone Performance: Results when the algorithm performs without human intervention.
- Training Set Details: Information on the size and ground truth establishment for the data used to train the 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.