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This device is capable of monitoring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, ST segment analysis.

Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.

The Infinity Alpha is a light-weight, handheld portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity Alpha is capable of measuring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST segment analysis, and 12-lead ST segment analysis. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced.

The provided text does not include detailed information regarding specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) of the Infinity Alpha patient monitor for each of its functionalities (e.g., heart rate, respiration rate, arrhythmia detection, etc.). It primarily focuses on regulatory approval and substantial equivalence to a predicate device.

Therefore, I cannot populate a table with acceptance criteria and reported device performance, nor can I provide information about sample sizes for test or training sets, expert qualifications, ground truth methods, or MRMC study details.

However, I can extract the information that is present:

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

• Acceptance Criteria: Not specified in the provided document. The document states that the device was "determined to be as safe and effective for its intended use as the predicate device" in accordance with applicable standards and internal design control procedures.
• Reported Device Performance: Not specified in terms of quantitative metrics. The document only states that "Clinical performance evaluations indicate that the Infinity Alpha Patient Monitor is substantially equivalent to the Infinity Delta series monitors."

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

• Not specified in the provided document.

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)

• Not specified in the provided document.

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

• Not specified in the provided document.

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 specified in the provided document. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers.

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

• The device is a standalone physiological monitor. The "clinical performance evaluations" would have assessed its standalone performance compared to the predicate device. Specific details or metrics of this evaluation are not provided.

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

• Not specified in the provided document. It states "Clinical performance evaluations," but the methodology for establishing ground truth within those evaluations is not detailed.

8. The sample size for the training set

• Not specified in the provided document.

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

• Not specified in the provided document.

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