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PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/CO2) monitor, and consists of a main unit, PF 6001, that can be equipped with 1 to 8 PF 6040 function units. An electrode E5250 or E5280 is connected to each function unit and is applied to a patient's skin. Electrode E5250 consists of a Clark sensor and is used for O2 measurement. Electrode E5280 is a combined Clark sensor and Stow-Severinghaus-type sensor, and is used for both O2 and CO2 measurement. Upon measurement, the electrode is heated to make the skin permeable to gas diffusion, which allows O2 and CO2 to diffuse through the skin into the sensor. The instrument is operated from its touch screen interface and allows the users to record, analyze and report top(22 and tcpCO2 values.

The provided document describes the PeriFlux 6000, a transcutaneous oxygen/carbon dioxide monitor, and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with safety and performance standards. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the way typically expected for an AI/ML device.

The information provided is largely about regulatory compliance, intended use, device description, and comparison to predicate devices, rather than a detailed performance study with quantitative acceptance metrics.

Therefore, I cannot directly extract the full requested information about acceptance criteria and a study proving device performance as it's not present in the provided text. I will address the points that can be inferred or are explicitly stated, and note where information is missing.

Summary of Acceptance Criteria and Device Performance for PeriFlux 6000

The provided document describes the regulatory submission for the PeriFlux 6000, focusing on its substantial equivalence to predicate devices and compliance with relevant safety and performance standards. It does not present specific quantitative acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, the "acceptance criteria" are implied to be adherence to recognized international consensus standards for medical electrical equipment and transcutaneous partial pressure monitoring.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the new device "meets the performance requirements" and "is equipped with the required safety mechanisms," and "fully complies" with the listed international standards. However, it does not provide detailed measurement accuracy, precision, bias, sensitivity, specificity, or similar quantitative performance metrics that would typically be expected from a device study. The provided text is a summary for regulatory clearance, focusing on equivalence and standard compliance rather than a detailed performance report.

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

• This information is not provided in the document. The filing focuses on compliance with standards rather than clinical testing with a specific test set.

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

• This information is not provided in the document. Ground truth establishment with experts is generally associated with clinical or image-based diagnostic studies, which is not the type of study described here for a transcutaneous monitor.

4. Adjudication method for the test set:

• This information is not provided in the document. Adjudication methods are typically used in studies involving expert review where consensus on ground truth is required.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not reported) as this device is a standalone physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• The PeriFlux 6000 is a standalone device for continuous non-invasive transcutaneous monitoring. The document states it is "a modern transcutaneous oxygen/carbon dioxide monitor that meets the performance requirements." While it doesn't detail a specific "standalone study" with quantitative results beyond compliance with standards, its function is as a standalone measurement device. The performance claims are inherently for the algorithm/device itself.

7. The type of ground truth used:

• For the technical and performance standards, the "ground truth" would be the defined specifications and test methods within the cited international consensus standards (e.g., IEC 60601-1, IEC 60601-2-23). The device's performance is measured against these established engineering and safety benchmarks.
• For the physiological measurements (tcpO2/tcpCO2), traditional ground truth in such devices often involves comparison to arterial blood gas measurements, but the document does not specify if such a comparison was part of the "performance requirements" that were met.

8. The sample size for the training set:

• This information is not applicable as the PeriFlux 6000 is a hardware monitor based on established physiological measurement principles (Clark sensor, Stow-Severinghaus-type sensor), not an AI/ML device that requires a "training set" in the conventional sense.

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

• This information is not applicable for the same reason as point 8.

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