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Oxicom Control is intended to be used to monitor and evaluate the analytical performance of the Waters Oxicom models 2000, 2100 and 3000 oxygen saturation meters for the measurement of oxygen saturation. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The three levels of oxygen saturation provided by the controls allow performance monitoring within the clinically important range. For In Vitro Diagnostic Use

The solutions in the 3-level Oxicom Control are a suspension of polystyrene beads in an inorganic, aqueous buffer solution with dyes to simulate the absorbance of light equivalent to that of whole blood at a range of oxygen saturation clinically relevant. Oxicom Control provides a convenient method of performing periodic OC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle. Oxicom Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.

The provided document is a 510(k) summary for the Bionostics Oxygen Saturation Control device and does not contain the detailed information necessary to complete all sections of your request. This type of document focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting extensive performance studies with specific statistical acceptance criteria and ground truth validation for software or AI-driven devices.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for tests. The tests mentioned (stability, correlation, precision, range) imply testing was performed on the Oxygen Saturation Control device itself, not on patient data in the context of an AI/algorithm.

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

Not applicable. This device is a quality control solution, not a diagnostic device that interprets patient data. Therefore, there's no ground truth established by medical experts in the way it would be for an AI diagnostic tool.

4. Adjudication method for the test set

Not applicable. 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

Not applicable. This is a quality control material, not an AI or software device used by human readers for diagnosis.

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

Not applicable. This is a quality control material, not an algorithm.

7. The type of ground truth used

For stability, precision, and range, the "ground truth" would be established by validated reference methods or expected performance characteristics of the control material itself, often using highly accurate laboratory instruments. For correlation to predicate device, the predicate device's established performance would serve as a reference.

8. The sample size for the training set

Not applicable. This is a quality control material, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

Summary of Device and Study Context from the Document:

The Bionostics Oxygen Saturation Control is a liquid control solution intended to monitor and evaluate the analytical performance of Waters Oxicom oxygen saturation meters. It contains suspended styrene beads and dyes to simulate the absorbance of light by whole blood at a range of oxygen saturation values.

The "study" referenced in the document is a series of non-clinical tests conducted to verify specific performance requirements:

• Closed bottle stability
• Stability after opening
• Correlation to predicate device
• Test precision and range

The document explicitly states "Summary of clinical tests submitted with the premarket notification for the device. N/A," indicating no clinical trials were conducted or required for this Class I medical device. The conclusions drawn are based on the comparison of technological characteristics, formulation, and intended use to predicate devices, supporting the claim of substantial equivalence.

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