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The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.

The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.

Here's an analysis of the provided text regarding the OxiCheck device, focusing on acceptance criteria and study information:

The document (K023565) describes the Caradyne OxiCheck, an oxygen analyzer. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the document primarily focuses on technical specifications and similarities to predicate devices, rather than detailed clinical study data typically associated with new medical device approvals.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a separate section. However, the "Design and Specifications" and "Performance Standards" tables effectively serve as the acceptance criteria that the device claims to meet.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly describe a separate "test set" and its sample size in the context of clinical or performance data for the OxiCheck itself. The information provided heavily relies on a comparison to predicate devices and compliance with international standards.

For the predicate devices (Ceramatec - Handi - K973282 and Caradyne - Criterion 60 - K000959), it's implied that their prior FDA clearance served as validation. The document states, "The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices." This suggests that the "test" primarily involved demonstrating that the OxiCheck's specifications and functionality are comparable to these already cleared devices, rather than conducting new, large-scale studies.

• Data Provenance: Not specified for any performance testing of the OxiCheck itself. The manufacturer is Caradyne, Ltd. in Galway, Ireland, suggesting the device development and internal testing likely occurred there.
• Retrospective/Prospective: Not applicable or specified for a distinct clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the information provided. The OxiCheck is an oxygen analyzer, and its "ground truth" would be established by reference gas mixtures or calibrated laboratory equipment, not by human expert opinion or interpretation of medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device's performance is measured against objective physical standards (e.g., accuracy against a known oxygen concentration), not subjective human interpretation requiring adjudication.

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

Not applicable. This is not an AI-assisted diagnostic device, nor is it a device that relies on human "readers" in the context of an MRMC study. It is a standalone measurement tool.

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

Yes, in essence. The provided performance specifications for the OxiCheck (measurement range, accuracy, response time, drift, etc.) describe its intrinsic, standalone performance without a human in the loop for its measurement function. The device's function is to measure and display oxygen concentration, which is an automated process. The human interacts with the device by reading its display and applying it in a clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance specifications listed, the ground truth would be based on highly accurate and calibrated reference gas mixtures (e.g., nitrogen/oxygen blends of known concentrations) used in a laboratory setting to test the device's accuracy, linearity, and response time. Environmental chambers would be used to test humidity, temperature, and pressure influences.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. Its functionality is based on electrochemical principles for oxygen sensing and electronic design, not learned patterns from data.

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

Not applicable, as no training set is relevant for this device.

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