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The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, stating that the CD Leycom 4 Fr Pressure/Volume Catheter has been found substantially equivalent to legally marketed predicate devices.

The letter discusses:

• The device's trade name, regulation number, regulation name, regulatory class, and product code.
• The date of receipt and review of the premarket notification.
• The FDA's determination of substantial equivalence.
• General controls provisions of the Act that the device must comply with.
• Contact information for specific advice and general information.
• The intended indications for use, stating that the catheters are "intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization where the quantitative assessment of Left Ventricular function is desired."

However, it does not contain specific details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size or ground truth establishment for a training set.

The document is primarily a regulatory clearance notification and does not include the technical study details requested.

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The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunctions with a pressure interface module during catheterisation laboratory procedures where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (CD Leycom Pressure/Volume Catheter) which primarily establishes substantial equivalence to a predicate device for marketing purposes. It does not contain details of performance studies, sample sizes, ground truth establishment, or expert evaluations.

Ask a specific question about this device

Ask a specific question about this device