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The Prizm Keratome Blade VII is to be used as a replacement blade for the blade in the non-disposable Moria M2 keratome for lamellar resection of the corner.

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I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device called "Prizm Keratome Blade VII," indicating that the device has been found substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about any specific study (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

The letter primarily focuses on the regulatory clearance process and states the device's indications for use based on its substantial equivalence to an existing product. It does not elaborate on the specific performance metrics or studies conducted to demonstrate that equivalence or to establish performance against acceptance criteria.

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SURGIN'S PRIZM BLADES ARE DESIGNATED AS REPLACEMENT BLADES FOR THE "BECTON DICKINSON BD - 3000 MICRO SURGICAL SYSTEM", TO BE USED FOR LAMELLAR RESECTION OF THE CORNEA

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This document is a 510(k) premarket notification letter from the FDA regarding the "PRIZM Keratome Blade." This type of document does not contain acceptance criteria or study results for device performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but not specific performance metrics or studies.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used to establish the ground truth," etc., are details typically found in a device's submission dossier, which is not provided here.

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The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea

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The provided text is a 510(k) premarket notification approval letter for the Surgin AccuBlade™ Microkeratome Blade, which primarily focuses on regulatory approval based on substantial equivalence to existing devices. It does not contain information about specific acceptance criteria for device performance, the details of a study that proves the device meets those criteria, or any of the other requested information regarding sample sizes, ground truth establishment, or clinical study methodologies.

Therefore, I cannot provide the requested table and study details from the given text. The document is a regulatory approval notice, not a clinical study report.

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This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.

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This looks like a 510(k) clearance letter for the "Surgin Kit" and "Ophthalmic Kit." The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA did not require clinical trials or performance studies demonstrating specific acceptance criteria for the Surgin Kit, because substantial equivalence typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness.

Therefore, for your request, I cannot provide the following information from the given document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided, as performance studies were not a requirement for this specific 510(k) clearance based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not provided.
6. If a standalone performance study was done: Not provided.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document is purely a regulatory clearance letter based on substantial equivalence to a predicate device, and thus does not contain the detailed performance data or study design information that your questions are asking for.

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