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The Edwards Pressure Cable when used with an Edwards' pressure monitoring sensor and connected to a compatible monitor, offers continuous assessment of hemodynamic parameters. The Edwards Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

The Edwards Pressure Cable is a reusable device that connects with a compatible monitor on one end, and an Edwards' pressure monitoring sensor on the other end to continuously measure hemodynamic parameters. The Edwards Pressure Cable acts as a sub-system module to a compatible monitor and has all the electronics, software and algorithms built into the cable to allow for monitoring and calculating patient hemodynamic parameters. Parameters available on the Edwards Pressure Cable include: Continuous cardiac output/continuous cardiac index (CO/CI), Cardiac power output/cardiac power index (CPO/CPI), Central venous pressure (CVP), Diastolic blood pressure (DIA), Mean arterial blood pressure (MAP), Mean pulmonary artery blood pressure (MPAP), Stroke volume/stroke volume index (SV/SVI), Systemic vascular resistance/systemic vascular resistance index (SVR/SVRI), Stroke volume variation (SVV), Systolic blood pressure (SYS)

The provided text is a 510(k) summary for the Edwards Pressure Cable (K191089). It states that the device is "substantially equivalent" to a predicate device, the HemoSphere Pressure Cable (K180881). Crucially, it explicitly states:

"No new testing was performed since the subject and predicate devices are identical and have similar intended use and indications for use. The Edwards Pressure Cable leverages the testing for the predicate HemoSphere Pressure Cable (HemoSphere Advanced Platform, K180881, cleared November 16, 2018)."

Therefore, the document does not contain an independent study or acceptance criteria specifically for the Edwards Pressure Cable, but rather references the testing previously conducted for the predicate device.

Based on the provided document, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document refers to adherence to several standards for medical electrical equipment, but does not provide a table of acceptance criteria or reported device performance in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it states that the predicate device's testing "passed" compliance with these standards.

   Standard	Acceptance
   IEC 60601-1:2005+A1:2012 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance	Passed
   IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and Tests	Passed
   IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General Requirements for Safety and Essential Performance- Collateral Standard: Usability	Passed
   IEC 60601-1-8 Medical Electrical Equipment, Part 1-8: General Requirements for Basic Safety and Essential Performance- Collateral Standard: General Requirements, Tests, and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems	Passed
   IEC 62304 Medical Device Software- Life Cycle Processes	Passed
   IEC 62366 Medical Devices- Application Usability Engineering to Medical Devices	Passed
   Software Verification (for Moderate Level of Concern)	Passed
   Electrical Safety and Electromagnetic Compatibility (EMC)	Passed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   This information is not provided in the document for the predicate device's testing. The document only mentions that the testing for the predicate device was performed.

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 as the device relates to physiological monitoring and its validation for "ground truth" would follow different methodologies than image-based diagnostics.

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 information is not applicable to this device. The Edwards Pressure Cable is a hardware component for physiological monitoring, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document states that the Edwards Pressure Cable "has all the electronics, software and algorithms built into the cable to allow for monitoring and calculating patient hemodynamic parameters." However, it does not describe a standalone algorithm performance study, but rather a system-level performance (safety, EMC, usability, software verification) that was "passed."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   This information is not explicitly stated in the document. For a pressure cable, "ground truth" for performance would typically involve comparison to highly accurate reference measurement systems in a controlled environment, but the specifics are not detailed here.

8. The sample size for the training set:
   This information is not provided in the document. The device contains software and algorithms, but the document does not detail a "training set" in the context of machine learning or AI models. It refers to software verification testing.

9. How the ground truth for the training set was established:
   This information is not provided in the document.

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