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The intended use of the MICOR 700 System with Auto I/A is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting

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I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the MICOR 700 with Auto I/A does not contain information regarding the acceptance criteria or the study that proves the device meets those criteria. The letter primarily focuses on the regulatory aspects of the clearance, such as the substantial equivalence determination, applicable regulations, and administrative requirements.

To answer your request, I would need access to a different document, such as the 510(k) summary or the full submission, which typically contains details about performance testing, validation studies, and the established acceptance criteria.

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The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

It appears there has been a misunderstanding. The provided FDA 510(k) clearance letter for the MICOR 700 System is for a Phacofragmentation System, which is a medical device used for surgery, specifically for cataract removal.

This document does NOT contain information about any AI/ML-based device, nor does it detail acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/ML performance.

Phacofragmentation systems are mechanical and electronic devices, and their "performance" criteria are typically related to:

• Power output and control: How effectively and safely they fragment the lens.
• Aspiration rate and vacuum control: How efficiently they remove fragmented lens material.
• Irrigation flow: Maintaining proper eye pressure during the procedure.
• Safety features: Overpressure limits, heat generation, sterile components.
• Biocompatibility: Materials used.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on this document. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML algorithms, not to a traditional surgical device like the MICOR 700 System.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it according to your requested criteria.

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The intended use of the MICOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

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I am sorry, but the provided text is a 510(k) clearance letter for the MICOR Lens Fragmentation System and does not contain any information about acceptance criteria or specific study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the given document.

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The intended use of the miCOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

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The provided text is an FDA 510(k) clearance letter for the miCOR System Lens Fragmentation System. This document, while indicating the device's clearance for market and its intended use, does not contain any information regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information in the table or the subsequent numbered points based solely on the text provided. The document focuses on regulatory compliance and the determination of substantial equivalence, not on the detailed technical study results.

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The intended use of the xPORT S Lens Fragmentation System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation, as well as ancillary functions such as vitreous aspiration and cutting

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the Carl Zeiss Meditec xPORT S Lens Fragmentation System does not contain any information regarding acceptance criteria, device performance studies, or details about AI model validation.

The document is a standard 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices for its indicated use (fragmentation and removal of cataracts, etc.). It outlines the regulatory classification, product codes, and general controls the device is subject to.

Therefore, I cannot provide the details you requested because the source material does not contain that information. To answer your request, I would need a document that describes the clinical performance testing, validation studies, or technical specifications of an AI-powered medical device.

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The intended use of the xPORT 304 (miCOR) System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

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The provided document, a 510(k) premarket notification letter from the FDA regarding the xPORT 304 (miCOR) System Lens Fragmentation System, does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria.

The document details the FDA's clearance of the device for marketing, confirms its substantial equivalence to predicate devices, and outlines regulatory requirements. It also includes the device's indications for use: "fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting."

Without information directly related to performance studies, acceptance criteria, or their validation, I cannot provide the requested details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment method for the training set.

The document is purely a regulatory clearance notice, not a clinical study report or a technical performance specification.

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The intended use of the xPORT System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.

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This document is an FDA 510(k) clearance letter for the xPORT Lens Fragmentation System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices for the fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.

However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

This letter is a regulatory clearance document, not a clinical study report. To fulfill the request, information from the actual 510(k) submission (which is typically much more extensive than just the clearance letter) would be required. Without that underlying data, it's impossible to describe the acceptance criteria and the study proving the device meets them.

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