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PM-2000XL Pro: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (Sp02), lovasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired C02 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.

PM-2000XL: The monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. 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. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

The PM-2000XL & PM-2000XL Pro Patient Monitors provide the following primary features:

PM-2000XL & PM-2000XL Pro Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, they are capable of storing, disnlaying, analyzing and controlling measurements, and they will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

PM-2000XL Patient Monitor can monitor parameters including SpO2, NIBP, EGG RESP, TEMP, C02, IBP

PM-2000XL Pro Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, C02, IBP, C.O. and AG

PM-2000XL is outfitted with a 8.4-inch display screen, PM-2000XL Pro 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.

PM-2000XL 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, EGG RESP, C02, IBP and Quick Temp.

PM-2000XL Pro Patient Monitor has parameter modules including SpO2 with EDAN-Sp02 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600. TEMP, EGG, RESP, C02, CO, IBP, AG.

The EDAN SpO2 module used in PM-2000XL Pro and PM-2000XL is also used by H1 100B Pulse Oximeter which has been cleared by FDA under K110922. The C02 module and Nellcor SpO2 module used in PM-2000XL Pro are the same to those used in M3B3, which has been cleared by K083821 in May 14, 2009.

PM-2000XL Pro could be configured with two different NIBP modules, one is EDAN NIBP module, the other one is Omron M3600 NIBP module; M3600 module used in PM-2000XL Pro is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003.

The C02 module and Nellcor SpO2 module used in PM-2000XL are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST Analysis used in PM-2000XL Pro is the same to that in PC EGG which has been cleared by FDA under K102854 and K092010.

This is a 510(k) summary for a patient monitor and, as such, typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed studies for device performance against specific acceptance criteria. The document explicitly states:

"This premarket notification submission demonstrates that PM-2000XL & PM-2000XL Pro Patient Monitor is substantially equivalent to the predicate device."

Therefore, the information you've requested regarding acceptance criteria, specific device performance studies, and ground truth establishment for a new device's algorithms (which would be necessary for AI/software-as-a-medical-device submissions) is not present in this document. This submission is for a patient monitor, which is a hardware device that incorporates various modules for physiological parameter monitoring. The performance of these modules is either cleared through previous 510(k)s (as explicitly stated for components like the EDAN SpO2 module, Nellcor SpO2 module, and Omron NIBP module) or is expected to meet established performance standards for such physiological monitors, without requiring a novel performance study to prove it for this specific integration.

Here's an analysis based on the provided text, explaining why much of the requested information is not available and what is stated:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria and reported device performance for the PM-2000XL & PM-2000XL Pro as a whole using new data. Instead, it relies on the substantial equivalence to a predicate device (M50 & M80 Patient Monitor K110922) and the prior clearance of its individual components/modules.

• Implied Acceptance Criteria: The implied acceptance criteria are that the device performs equivalently to the predicate device and that its individual modules meet their previously established performance standards.

The document mentions that:

• The EDAN SpO2 module is also used by H1 100B Pulse Oximeter cleared under K110922.
• The C02 module and Nellcor SpO2 module are the same as those used in M3B3 (cleared under K083821) and M3B (cleared under K083821).
• The Omron M3600 NIBP module is the same as that used in BX-10 (cleared under K032857).
• Arrhythmia and ST Analysis used in PM-2000XL Pro are the same as that in PC EGG (cleared under K102854 and K092010).

This signifies that the performance of these individual components has already been evaluated and deemed acceptable in their preceding 510(k) clearances.

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

Not applicable in this submission. The document relies on the existing clearances of its components and the substantial equivalence to the predicate device. New clinical performance data for the integrated system is not presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment for a novel algorithm's test set performance is not part of this 510(k) submission, as it's not demonstrating the performance of a new algorithm.

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

Not applicable.

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 applicable. This is not an AI-assisted diagnostic or interpretative device requiring MRMC studies. It is a physiological monitoring device.

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

Not applicable in the context of a new, standalone algorithm. The "algorithms" present are for the interpretation of physiological signals (e.g., arrhythmia detection, ST segment analysis), which are noted to be the "same to that in PC EGG which has been cleared by FDA under K102854 and K092010." This implies their standalone performance was assessed in those prior submissions, not in this one.

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

Not applicable to this 510(k). The ground truth for the performance of the various physiological monitoring parameters (SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection accuracy, etc.) would have been established during the development and clearance of the individual modules or the predicate device, likely using recognized clinical standards and reference methods for each physiological parameter.

8. The sample size for the training set:

Not applicable. This submission is not for a new machine learning algorithm that requires a training set.

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

Not applicable.

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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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