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The DK7786 handpiece is used in combination with the One Series™ Ultra Cartridge to fold and assist in inserting TECNIS® 1-Piece intraocular lenses. ONLY into the capsular bag.

Duckworth & Kent Ltd Model DK7786 Injector

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Duckworth & Kent Ltd. Injector DK 7786". This document does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The letter explicitly states that the device is a Class I product (KYB) and has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on a comparison to existing devices rather than a new clinical study with specific performance metrics.

Therefore, I cannot provide the requested information based on the input text. The prompt asks for details that are not present in this regulatory document.

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To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.

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The provided text is a 510(k) summary for a medical device (Lens Delivery System) and does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The document is a regulatory letter from the FDA stating that the device has been found substantially equivalent to a predicate device and can be marketed. It discusses:

• Device Name: Duckworth & Kent Ltd, Lens Delivery System, Model DK7788
• Regulation Number/Name: 21 CFR 886.4300, Intraocular Lens Guide
• Regulatory Class: Class I
• Product Code: MSS
• Indications for Use: To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.

Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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To fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Duckworth & Kent Ltd. Cartridge Lens Delivery System. Model DK7797". It states that the device is substantially equivalent to a legally marketed predicate device, but it does not include details about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any other specifics related to a study proving the device meets acceptance criteria.

The letter focuses on regulatory approval based on substantial equivalence, not on the detailed results of a performance study.

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When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure. This injector will facilitate the insertion and proper placement of the ring in the capsular bag.

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I am sorry; your request cannot be fulfilled.
The document you provided is a 510(k) clearance letter from the FDA for a medical device called "Capsule Tension Ring Inserter." This type of document declares substantial equivalence to a predicate device and does not typically include detailed information on acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance. These elements are usually found in study reports, clinical trial documentation, or more detailed regulatory submissions for devices requiring clinical evidence.

Therefore, I cannot extract the requested information from the provided text.

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Folding and injection of Chiron Softex LI61U lens implant into the eye using a Chiron Microsert IC-5BU disposable cartridge.

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This document is a 510(k) premarket notification letter from the FDA to Duckworth & Kent, Ltd. regarding their Lens Delivery System DK7782-1. This is approval for a Class I medical device, which is considered low risk and does not typically require extensive clinical data or performance studies in the same way that software algorithms or higher-risk devices do.

As such, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and human reader studies is not present in this type of regulatory document for this specific device. These requirements are usually associated with devices where clinical performance and accuracy are key to safety and effectiveness, such as diagnostic AI tools.

Therefore, I cannot extract the requested information from the provided text.

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