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M80: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
MSO: The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

M50/M80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
M50 Patient Monitor can monitor parameters including SpO2, NIBP. ECG, RESP, TEMP, CO2, IBP.
M80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, CO2, IBP, C.O. and AG.
M50 is outfitted with a 8.4-inch display screen, M80 is 15-inch, as well as an equal large touch screen. which enables the operation by touching the screen, thus offering convenience for doctors and nurses.
M50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG RESP. CO2, IBP and Ouick Temp.
M80 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SpO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, CO2, CO, IBP, AG

The provided 510(k) submission for the Edan Instruments Patient Monitor (Models M50 and M80) describes the device and claims substantial equivalence to predicate devices. However, it does not contain the specific details required to answer all your questions regarding acceptance criteria and performance studies.

This type of 510(k) summary focuses on demonstrating equivalence to existing devices rather than presenting detailed scientific studies with acceptance criteria and specific performance metrics for the new device. The document mentions "Verification and validation testing" and "similar performance specifications" to predicate devices, but does not provide the results of these tests or explicit acceptance criteria.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given document. The submission claims "similar performance specifications" to predicate devices, but no specific performance metrics or acceptance criteria are listed for the M50/M80 Patient Monitor itself. It only references that certain modules used within the M50/M80 were cleared under their own 510(k)s, implying that those modules met their respective performance criteria.

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

This information is not provided in the given document. The submission mentions "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Final validation," but does not detail the methodologies, sample sizes, or data provenance for these tests.

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 document.

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

This information is not provided in the given 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

This information is not provided in the given document. This device is a patient monitor, not an AI diagnostic tool, so an MRMC study with human readers assisting AI would not be applicable.

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

This information is not explicitly provided in the given document. The "Verification and validation testing" and "Final validation" mentioned likely included testing of the device's algorithms and functions in a standalone capacity, as is typical for medical devices. However, no specific details of such studies are presented.

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

This information is not provided in the given document.

8. The sample size for the training set

This information is not provided in the given document. As this is a traditional patient monitor rather than a machine learning/AI device, the concept of a "training set" in the context of supervised learning algorithms might not directly apply in the same way. The device's internal algorithms would be developed and validated against established physiological models and sensor data, but these are typically not referred to as "training sets" in the context of a 510(k) for such devices.

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

This information is not provided in the given document. (See point 8 regarding the applicability of "training set" for this device type).

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison of indications for use, operating principles, testing modules, and general performance specifications to predicate devices. It does not present the detailed results of performance studies, specific acceptance criteria, or the methodologies for establishing ground truth or testing populations for the M50/M80 Patient Monitor itself. This level of detail is typically found in the full 510(k) submission, not just the summary.

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