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The VEO Multigas Monitor for Pocket PC is intended to provide monitoring of carbon dioxide and oxygen during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult and pediatric patients.

The VEO Multigas Monitor for Pocket PC combines a miniature mainstream infrared gas analysis bench with an ultra-fast response oxygen fuel cell. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the K051857 device, the VEO Multigas Monitor for Pocket PC:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria (e.g., "accuracy must be within ±X%"). Instead, it broadly compares the device's performance to its predicate devices in several key areas. The acceptance criteria are implicitly defined as being "equivalent or superior" to the predicate devices.

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

• Sample Size for Test Set: Not specified. The document states "Non-clinical testing in direct comparison to predicates throughout the operating range was conducted." It doesn't provide specific numbers of tests or gas samples used.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. It was a "non-clinical" study, implying laboratory testing rather than patient data.

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

• Number of Experts: Not applicable. The ground truth for the non-clinical testing was established using "calibrated gas samples and legally marketed anesthesia and ventilation devices," not human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the testing involved calibrated gas samples and established devices, there would be no need for expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The study was a non-clinical comparison against predicate devices using calibrated gas samples and other medical equipment, not a human-reader study. Therefore, there's no reported effect size regarding human reader improvement with or without AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Standalone Study Done: Yes. The described "Non-clinical testing in direct comparison to predicates throughout the operating range" is a standalone performance study. The device's performance (response time, accuracy, precision, reliability) was directly measured and compared against established standards (calibrated gas samples) and predicate devices.

7. Type of Ground Truth Used

• Type of Ground Truth: "Calibrated gas samples and legally marketed anesthesia and ventilation devices." This means the ground truth was based on precisely known concentrations of gases and the output from reference medical equipment.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware multigas monitor, not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" would involve calibration and engineering design, not data-driven machine learning.

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

• Ground Truth for Training Set: Not applicable, as it's not an AI/ML device that uses a "training set" in the context of data. The device's accuracy and performance are established through calibration and engineering validation using known physical standards.

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