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The INFINITY Modular monitors are capable of monitoring: Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, Apnea, ST Segment Analysis, 12-Lead ST Segment Analysis, tcp02/tcpC02, EEG signals, FiO2. With the MultiGas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide. With etCO2 the monitors can measure end tidal carbon dioxide. inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter. The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, 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 to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network. The primary modification implemented with the release of software version VF3 is support for the INFINITY Microstream pod, an etCO2 pod that utilizes Oridion's Microstream technology. This technology utilizes a sidestream sampling flowrate appropriate for neonates. The VF3 software release also includes the support of additional pulse oximeter sensors.

The provided document is a 510(k) summary for a medical device (Siemens INFINITY Modular Monitors). It describes modifications to the device and asserts substantial equivalence to a legally marketed predicate device.

It does not contain information on acceptance criteria, a specific study proving the device meets acceptance criteria, or performance metrics typically associated with AI/algorithm-based devices.

The document discusses:

• Device: Siemens INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000)
• Modifications: Support for the INFINITY Microstream pod (etCO2) and additional pulse oximeter sensors with VF3 software release.
• Claim: The modifications have not altered the basic fundamental technology, and testing indicated no new issues relative to safety and efficacy.
• Regulatory Status: Substantial equivalence to predicate devices (K983632, K990563, K003243, K982730, K980882).

Therefore, I cannot provide the requested information as it is not present in the given text.

The prompt asks for details about an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device. The provided FDA 510(k) summary is for hardware and software updates to a patient vital signs monitor, not an AI/algorithm device. The assessment mentioned ("Assessment of non-clinical performance data for equivalence: See Section J") would refer to traditional medical device testing (e.g., electrical safety, EMC, functional verification) to ensure the updated device performs as intended and is safe, similar to the predicate device. It does not involve the types of studies or performance metrics relevant to AI models, such as sensitivity, specificity, F1-score, AUC, etc., which would be compared against a ground truth established by experts.

To reiterate, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, training set ground truth establishment) is not found in the provided 510(k) summary because it describes a different type of medical device submission than one for an AI/ML algorithm.

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