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The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Cbyon System with Image Enhanced Fluoroscopy Module." This type of document primarily confirms that a new device is substantially equivalent to a predicate device already on the market, rather than detailing clinical study results or performance criteria for a novel AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this FDA clearance letter.

The letter focuses on regulatory approval based on substantial equivalence, and not on a detailed performance evaluation as would be required for a novel AI/ML diagnostic or prognostic device.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

   • This information is not present in the 510(k) clearance letter. The letter confirms substantial equivalence, not detailed performance metrics against specific acceptance criteria.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable/Not found in this document. This document is not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not found in this document.

4. Adjudication method for the test set:

   • Not applicable/Not found in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable/Not found in this document. The device is a "computer-aided, image-guided system," which implies human interaction, but MRMC study details are not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable/Not found in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Not found in this document.

8. The sample size for the training set:

   • Not applicable/Not found in this document.

9. How the ground truth for the training set was established:

   • Not applicable/Not found in this document.

Summary based on the provided document:

The provided text is an FDA 510(k) clearance letter for the Cbyon System with Image Enhanced Fluoroscopy Module. This document serves as regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device. It does not contain the detailed clinical study results, performance metrics, sample sizes, ground truth methodologies, or expert qualifications that would be typically found in a clinical study report or a premarket approval (PMA) submission for a novel device, especially an AI/ML product.

Therefore, none of the specific questions regarding acceptance criteria and study details can be answered based solely on the provided FDA 510(k) clearance letter. The letter simply states the device is "substantially equivalent" to predicate devices for its stated "Indications for Use," which are for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.

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