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Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

The subject device is a family of Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The oxygen sensors are all electrochemical galvanic type devices. The difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time. The family of oxygen sensors concept extends to OEM manufacturers of anesthesia and respiratory therapy equipment. Again, the difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time in order for the OEM to exercise a degree of control over the recurring replacement of oxygen sensors.

The provided text describes a 510(k) premarket notification for "Percent Oxygen Sensors" by CareOx, LLC, referencing the predicate device K952736 by Analytic Industries Percent Oxygen Sensors. The submission argues for substantial equivalence based on identical technology, principle of operation, indications for use, and similar operating specifications, environment of use, and patient population.

However, the document does not contain the detailed acceptance criteria for standalone device performance, nor the specific results of a study proving the device meets those criteria. It states that "The subject devices are manufactured by Analytical Industries Inc. and were cleared under K952736. CareOx, the sponsor of this submission is purchasing final, finished oxygen sensors from Analytical Industries Inc. with the private label of CareOx." This implies that the device itself is identical to the predicate.

The document mentions "Non-clinical Testing" including "Accuracy, Precision, Specificity, Sensitivity, Linearity, Range, Response time" and states that "We have performed the applicable test from ISO 80601-2-55." However, it does not provide the acceptance criteria for these tests or the reported performance results against those criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing mentioned is "Non-clinical Testing" performed to ISO 80601-2-55.

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

• This information is not applicable and not provided. The testing described is non-clinical (device performance against standards), not clinical evaluation requiring expert ground truth for interpretation like imaging studies.

4. Adjudication method for the test set

• Not applicable and not provided. See point 3.

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

• No, an MRMC study was not done. This device is an oxygen sensor, not an AI-assisted diagnostic tool.

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

• Yes, the non-clinical testing described (Accuracy, Precision, Specificity, Sensitivity, Linearity, Range, Response time) is considered standalone performance testing of the device itself. Specific results are not provided in this document, but the claim is that "applicable test[s] from ISO 80601-2-55" were performed.

7. The type of ground truth used

• For the non-clinical tests, the ground truth would typically be established by calibrated reference standards (e.g., known concentrations of oxygen for accuracy and linearity testing). The document does not explicitly state the specific reference standards used.

8. The sample size for the training set

• Not applicable. This device is a sensor, not a machine learning algorithm that requires a training set.

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

• Not applicable. See point 8.

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