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The VITRA MULTISPOT Laser photocoagulator is indicated for use in the treatment of ocular pathology of anterior and posterior 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
• · Retinopathy of Prematurity
• · Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

VITRA MULTISPOT is a laser photocoagulator emitting a treatment beam of green (532nm) laser radiation. The treatment beam is delivered through a delivery system and is aimed using a Red Laser diode (635-650nm).

The Quantel Medical VITRA MULTISPOT Laser can be connected with the following delivery systems:

• 1. Scanning Laser Delivery System adaptor
• 2. Slit Lamp adaptor
• 3. Indirect ophthalmoscope adaptor

Output power from all these delivery systems are calibrated to deliver a maximum of 1.5 watts. The control box is a tactile LCD screen which is part of the main housing.

The provided text describes a 510(k) summary for the Quantel Medical VITRA MULTISPOT, a laser photocoagulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth are not present in the provided document. The document states that "Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications and was substantially equivalent to the predicate devices." This implies that the acceptance criteria are likely related to meeting design specifications and achieving comparable performance to the predicate devices, as assessed through laboratory testing.

Here's a breakdown of what information can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative design specifications (e.g., laser power accuracy, spot size consistency, pulse duration accuracy, beam quality, safety interlock performance) and the precise metrics/results obtained from the laboratory testing that demonstrate these specifications were met.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information: The document does not describe a "test set" in the context of patient data or clinical performance evaluation. The "testing" mentioned is laboratory-based. Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Missing Information: No clinical test set or ground truth establishment by experts is described in the provided document. The evaluation focuses on laboratory performance and substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Missing Information: As no clinical test set with human assessment is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Missing Information: An MRMC comparative effectiveness study is not mentioned. This device is a laser photocoagulator, a treatment device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this type of study is not applicable to the information provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Missing Information: This is not an algorithm-only device. It is a physical medical device (laser photocoagulator) operated by a human. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Missing Information: If by "ground truth" we refer to the standard against which the device's technical specifications were measured in the lab, it would likely be established engineering standards, regulatory requirements, or the performance specifications of the predicate devices. No clinical "ground truth" (expert consensus, pathology, outcomes data) is mentioned as part of the evaluation for this 510(k).

8. The Sample Size for the Training Set

Missing Information: The device (VITRA MULTISPOT) is a laser photocoagulator, not an AI/machine learning model that requires a "training set" in the conventional sense. The regulatory submission primarily relies on demonstrating that its design and performance are substantially equivalent to already cleared predicate devices through laboratory testing and engineering analysis.

9. How the Ground Truth for the Training Set Was Established

Missing Information: See point 8. No training set is described for this type of device.

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