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PMS8210A Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions.

The patient parameters that can be monitored by PMS8210A Model Code 500 are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2), Temperature (TEMP) and End-tidal CO2 (EtCO2) . Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The PMS8210A Model Code 500 is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.

The PMS8210A Model Code 500 is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.

PMS8210A Model Code 500 Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), End-tidal (etCO₂). The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user. The submitted device is the same as the predicate with two differences. The new model has added an etCO2 function and the Temp module has been changed. The new Temp module is a previously FDA cleared device.

The provided text describes a 510(k) premarket notification for the PMS8210A (IRIS) Multi-Parameter Patient Monitor Model Code 500. This device is a multi-parameter patient monitor intended for use in healthcare facility settings.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various standards and directives to which the device conforms, indicating these as the acceptance criteria. The device's performance is reported as meeting these standards, implying "Same" as the predicate device or conforming to the specified standards without providing specific numerical performance data within the summary itself.

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

The provided text does not contain details regarding the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). The document refers to conformance with standards rather than specific clinical trial data with patient samples.

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 information is not provided in the document. The testing described largely pertains to engineering and performance standards, not clinical validation based on expert-established ground truth.

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

This information is not provided as the document does not describe a setting where expert adjudication of a test set would be applicable (e.g., image interpretation).

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:

This is not applicable and no such study was reported. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

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

The document mentions "completed performance testing in accordance with IEC standards" and "Third Party safety testing". This implies standalone testing of the device's functions against recognized standards. However, specific details of "algorithm only" performance for individual parameters are not explicitly detailed beyond conformance. The monitor operates as a standalone device to acquire and display physiological signals.

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

For the performance testing mentioned (e.g., NIBP, SpO2, Temperature, ECG), the ground truth would typically be established by reference measurement devices that are calibrated and traceable to national or international standards. For example, blood pressure measurements would be compared to a validated reference sphygmomanometer, and temperature to a calibrated thermometer. The document does not specify these details but implicitly relies on the methods outlined in the cited IEC and ISO standards.

8. The sample size for the training set:

This information is not provided. The device is a patient monitor, not a machine learning algorithm that typically requires a large training set in the way AI/ML devices do. While it has software of "Moderate concern," this implies software validation, not necessarily a machine learning training dataset.

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

This information is not provided. As noted above, the submission does not detail a machine learning component requiring a training set with established ground truth in the typical sense.

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The PMS8210A Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions.

The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.

The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.

PMS8210A Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), Heart rate (HR) and Pulse Rate (PR), The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user.

The provided text does not contain detailed information about specific studies, acceptance criteria, or performance data for the PMS8210A (IRIS) Multi-parameter Patient Monitor. Instead, it focuses on comparing the device's technical specifications and adherence to various medical standards with a predicate device (PM-9000 EXPRESS PATIENT MONITOR).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information.

The document primarily acts as a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness and are as safe and effective as the predicate device.

The study described is a comparison of the PMS8210A Multi-parameter Patient Monitor's specifications and compliance with relevant medical standards against a predicate device, the PM-9000 EXPRESS PATIENT MONITOR (K053234). The intent is to demonstrate that the subject device is substantially equivalent to the predicate device.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various technical specifications and accuracy claims for the PMS8210A device (Subject Device) and compares them to the predicate device. While these are performance characteristics, they are not explicitly labeled as "acceptance criteria" through a formal study results table. The implication is that meeting or being comparable to the predicate's performance, and adhering to referenced standards, constitutes meeting acceptance criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance:
This information is not provided in the given text. The document refers to "performance testing in accordance with IEC standards" but does not detail the size or nature of the test set or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. The document focuses on technical specifications and standard compliance, not clinical ground truth establishment by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given text.

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:
This information is not applicable/provided. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone monitor. Its performance is assessed against technical specifications and standards (e.g., IEC, AAMI, EN, ISO). The document states the device has "software of Moderate concern" and that "the appropriate level of Software evaluation was performed," but does not detail the standalone performance study specific to an algorithm. The overall product performance is standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for evaluating the device's technical specifications and accuracy is largely based on measurements against established reference standards and calibrated equipment, as implied by adherence to standards like ANSI/AAMI SP10 for NIBP accuracy and ASTM E1112 for temperature accuracy. For SpO2, it leverages the Nellcor SpO2 module, implying its proven accuracy. There is no mention of expert consensus, pathology, or outcomes data as ground truth in this document.

8. The sample size for the training set:
This information is not provided in the given text. As a patient monitor rather than an AI/ML algorithm requiring a training set in the typical sense, this concept might not directly apply or is not detailed. The "software of Moderate concern" does not imply a classical AI/ML model.

9. How the ground truth for the training set was established:
This information is not provided in the given text, and likely not applicable in the context of this traditional medical device.

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