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The A.R.C. Laser Fox Laser System is indicated for retinal and pan retinal photocoagulation, endophotocoagulation and transcleral cyclophotocoagulation for the treatment of: Diabetic Retinopathy Retinal tears and detachment Age related macular degeneration Retinopathy of prematurity Primary open angle glaucoma Refractory glaucoma

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The provided text is an FDA 510(k) clearance letter for the A.R.C. Laser Fox Laser System and Accessories. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters requested in your prompt.

The letter primarily focuses on:

• Confirming the device's substantial equivalence to a predicate.
• Listing the regulation number, regulation name, and product code.
• Indicating the general controls provisions of the Act that apply.
• Providing contact information for device-related inquiries.
• Listing the "Indications For Use" for the device, which describes the medical conditions it is intended to treat.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a clinical study report, a summary of safety and effectiveness data, or a detailed technical submission for the device that outlines its performance evaluation.

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An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

I am sorry, but the provided text is a 510(k) clearance letter for the VMate™ Vitreous Cutting System. This document focuses on the regulatory clearance for a medical device and does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt regarding an AI/algorithm-based device.

Therefore, I cannot extract the information required to populate the table and answer the subsequent questions from this document.

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The SCMD-1000 blades are to be used with the SCMD Microkeratome.

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I apologize, but the provided text from the FDA 510(k) letter for the SCMD-1000 device does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This document is a notification of substantial equivalence and does not detail the technical performance or validation studies of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The MMK-1000 is designed to produce a corneal flap.

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This document is a 510(k) clearance letter from the FDA for a microkeratome device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document confirming the device's substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given input.

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The CBALK-1000 blades are to be used with the Chiron Microkeratome.

CBALK-1000 Blades

The provided document is an FDA 510(k) clearance letter for the CBALK-1000 Blades manufactured by Howard Instruments, Inc. This letter determines substantial equivalence to a predicate device, allowing the product to be marketed.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria. It is a regulatory clearance, not a performance study report.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific device based on the given text.

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