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The non-invasive CerOx 3215FOP monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx3215FOP monitor is intended for monitoring of newborn - adult. The prospective clinical value of data from the CerOx 3215FOP monitor has not been demonstrated in disease states. The CerOx 3215FOP monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3215FOP uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue. CerOx Model 3215FOP is identical to the CerOx Model 3210FO technically and operationally.

The provided text describes a 510(k) submission for the CerOx Model 3215FOP, which is a blood flowmeter. The submission asserts substantial equivalence to a predicate device, the CerOx 3210FO.

Crucially, the document explicitly states that no performance testing, animal testing, or clinical studies were included in this 510(k) submission. Instead, the argument for substantial equivalence relies on the fact that the CerOx Model 3215FOP is "identical to the CerOx Model 3210FO technically and operationally."

Therefore, based on the provided text, the device itself (CerOx 3215FOP) does not have its own acceptance criteria or a study provided to demonstrate it meets them. Its acceptance is predicated on the substantial equivalence to a previously cleared device.

Since there are no performance studies described for the CerOx Model 3215FOP in this document, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies.

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