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The MED-LOGICS ML7090 microkeratome blades are to be used, as replacement blades for the AMO Amadeus TM Microkeratome, to perform lamellar keratectomy procedures.

Microkeratome Blade

This document is a 510(k) premarket notification acceptance letter from the FDA for the ML 7090 Microkeratome Blade. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Since the device is a Class 1 device, it is exempt from needing clinical studies, hence, the document does not mention any such studies.

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The Med-Logics 7050CLB microkeratome blades are to be used, as replacement blades for the Moria M2™ microkeratome, to perform lamellar keratectomy procedures.

Microkeratome Blade

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Med-Logics Microkeratome Blade, Model 7050CLB." This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm performance evaluation.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and may be marketed. It discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot provide the requested information such as:

• A table of acceptance criteria and reported device performance
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth for test sets
• Information on MRMC studies or standalone algorithm performance
• Training set details

This type of information would typically be found in the supporting documentation submitted with the 510(k) application, not in the FDA's decision letter itself.

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The Med-Logics 7020CLB microkeratome blades are to be used as replacement blades for the Moria C-B™ microkeratome.

Microkeratome Blade

The provided text is a 510(k) premarket notification letter from the FDA for a medical device (Med-Logics Model 7020CLB™ Microkeratome Blade). This type of document is an approval letter for a device that has demonstrated substantial equivalence to a predicate device, not typically a report of a new study designed to prove acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, especially with details like sample size, ground truth, and expert adjudication, is not present in this document.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

This means the approval is based on demonstrating equivalence, not on a new clinical study with acceptance criteria for device performance as a novel invention.

Therefore, I cannot provide the requested information from the given text.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.

Med-Logics, Inc., Administration Set (UT 3004)
Med-Logics, Inc., Drainage Bag (UT 3002)
Med-Logics, Inc., Universal Tubing Set (UT 3000)

The provided document is a 510(k) premarket notification letter from the FDA regarding Med-Logics, Inc.'s Administration Set, Drainage Bag, and Universal Tubing. This document is a regulatory letter approving a medical device based on its substantial equivalence to pre-existing devices. It does not contain information about acceptance criteria or study results in the context of device performance, algorithm evaluation, or clinical trials which are typically found in design validation reports or clinical study summaries.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval rather than technical performance data or study methodologies.

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The ML Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is no I he ML MICrokeratome is used to perform athin circular corneal cap.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the ML Microkeratome, acknowledging its substantial equivalence to a predicate device. It does not include details about device performance, specific acceptance criteria, study methodologies, or training data for AI models.

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For use in cataract surgery to irrigate and aspirate cataract material.

Not Found

I apologize, but this document contains general regulatory correspondence from the FDA regarding a 510(k) submission for a medical device called "ML-Disposable Pak." It explicitly states that this is an "Indications For Use Statement" for a device used in cataract surgery to irrigate and aspirate cataract material.

This document DOES NOT contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or any of the other specific items you've requested.

Therefore, I cannot provide the requested table and information based on the text provided.

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