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The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02) and is intended for use on adult, pediatric and neonatal patients in the care of health care professionals.

The CAS 750E Series Monitor is a multi-parameter patient monitor based on the exterior design and platform of the CAS 750C Patient Monitor. The 750E features a capnograph equivalent to the Oridion Microstream Digital C02 for the continuous non-invasive measurement and monitoring of carbon dioxide concentration in expired and inspired breath. Monitors in the series also have a choice of MasimoSET® or Nellcor® OxiMAX® Sp02 technology, and a ECG, heart rate, respiration rate and temperature.

All ten monitors in the 750E series have ECG, respiration and temperature, as one module. Eight of the ten have an additional module consisting of a pulse oximeter with a choice of MasimoSET® or Nellcor® technology. Nine of the ten monitors in the series feature non-invasive blood pressure measurement which is based on the CAS series oscillometric technology. The fourth parameter in two of the ten monitors in the series is a capnograph to measure EtC02. With the exception of the ECG/Respiration/Temperature module, all other modules are found in the CAS 750C Series Monitor -(K050844).

The 750E monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, its features include an easily replaced Nickel Metal Hydride rechargeable battery pack, and a backlit LCD display with both waveform and a numeric display.

The provided text describes a 510(k) submission for the CAS 750E Series Monitor, a multi-parameter patient monitor. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

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

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric table, but rather outlines the standards the device was tested against (non-clinical) and the clinical validation methods for certain parameters to demonstrate substantial equivalence. The "device performance" is implicitly that it met these standard requirements.

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

• NIBP: The document states that the NIBP parameter "has been clinically demonstrated to meet the clinical accuracy of AAMI SP10: 2002." AAMI SP10 specifies requirements for clinical validation, often involving a certain number of subjects (e.g., typically 85 subjects with specific demographic distribution for accuracy studies). However, the exact sample size used for the CAS 750E's NIBP clinical demonstration, or the provenance, is not explicitly stated in this document. It refers to its previous demonstration.
• EtCO2 and SpO2: No specific test set sample size is mentioned for these parameters as the modules are "unchanged" from OEM suppliers whose performance was already established in their own premarket submissions.
• ECG, Impedance Respiration, Temperature: Performance was validated through "in-house validation plans." No specific sample size or data provenance is provided.

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 document refers to adherence to standards and in-house validation, but does not detail the specific ground truth establishment process or the experts involved.

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

This information is not provided in the 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 is not applicable to this device. The CAS 750E Series Monitor is a multi-parameter patient monitor for physiological measurements, not an AI-assisted diagnostic tool that requires human reader interpretation or MRMC studies.

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

This is not applicable in the context of advanced algorithms. The device performs direct physiological measurements and displays them to healthcare professionals; it is not an algorithm that produces interpretations or diagnoses without human oversight. Its "standalone performance" is its ability to accurately measure the intended physiological parameters.

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

• NIBP: The ground truth for NIBP clinical accuracy would typically involve reference blood pressure measurements (e.g., from an intra-arterial line) as per AAMI SP10 standards.
• EtCO2 and SpO2: Ground truth for these parameters would typically involve highly accurate reference measurements (e.g., co-oximetry for SpO2, calibrated gas analyzers for EtCO2).
• ECG, Impedance Respiration, Temperature: Ground truth for these would involve established reference measurement methods for each physiological parameter during validation.

However, the explicit details of the ground truth methods are not provided in the document, only that the parameters were validated against standards or in-house plans.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML model that undergoes a training phase with a dedicated dataset. It's a hardware-based physiological monitor.

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

This information is not applicable for the same reason as point 8.

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