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The non-invasive CerOx 3210F monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3210F uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. In addition, it employs principles similar to those of Laser Doppler flowmetry to monitor the microcircular blood flow in tissue. CerOx Model 3210F is identical to the CerOx Model 3210. It utilizes the same technical and operational methods.

The provided text is a 510(k) summary for the CerOx Model 3210F device. It describes the device, its intended use, comparison to predicate devices, and FDA clearance. However, it does not contain specific details about clinical studies, acceptance criteria, ground truth establishment, sample sizes for test or training sets, expert qualifications, or adjudication methods in the way a detailed study report would.

The document states that the CerOx Model 3210F is identical to the CerOx Model 3210 in hardware and operation for tissue oximetry, and performs an additional analysis for microcirculatory blood flow. The conclusion of the 510(k) is based on substantial equivalence to predicate devices (CerOx 3210 for tissue oximetry and Laserflo Blood Perfusion Monitor BPM2 for microcirculation blood flow) rather than detailed clinical effectiveness studies with explicit acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth data are not present in this 510(k) summary. I can only provide information that is explicitly stated or can be inferred from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary concludes substantial equivalence based on the device being "as safe and effective as" and "substantially equivalent to" the predicate devices, rather than on specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and direct reporting of the device's performance against those criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The filing is based on substantial equivalence to existing devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the 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

There is no indication of an MRMC comparative effectiveness study being performed, nor is there any mention of AI in the context of this device. The CerOx Model 3210F is an oximeter/flowmeter and does not appear to involve AI assistance for human readers/clinicians, according to this summary.

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

This information is not provided in the document. The device is described as a monitor intended for use by medical professionals ("adjunct monitor").

7. The Type of Ground Truth Used

This information is not explicitly stated in the document. Since the device monitors regional hemoglobin oxygen saturation and microcirculation blood flow, ground truth would typically come from a reference standard for these physiological measurements, but the summary does not specify how this was established or if such ground truth was used for a specific clinical trial (which is not described in detail). The basis for equivalence is the device's mechanism and performance being similar to the predicate devices.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set, as the filing is for substantial equivalence and not a de novo clearance requiring extensive performance data derived from machine learning or similar algorithms that would involve training sets.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the document, as no training set is mentioned or implied.

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