(63 days)
The PreSep Oximetry and PediaSat Oximetry Catheters are indicated for hemodynamic monitoring in adults and pediatrics through blood sampling, hemodynamic monitoring and oxygen saturation measurement.
The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.
The Vigileo Arterial Pressure Cardiac Output /Oximetry Monitor is indicated for continuously measuring arterial pressure cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.
The PreSep Oximetry and PediaSat Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation in adults and pediatrics. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The dilator included with either the PreSep Oximetry or PediaSat Oximetry Catheter is used to enlarge the opening in a vessel for preparation of percutaneous entry of the catheter.
The Vigileo APCO/Oximetry monitor is a microprocessor-based instrument which, when connected to a dual disposable pressure transducer (DDPT), continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry) in adults or pediatrics. The monitor also calculates other derived parameters including cardiac index, stroke volume, stroke volume index, stroke volume variation, system vascular resistance, and systemic vascular resistance index.
The provided text describes a 510(k) summary for the Edwards Lifesciences PreSep Oximetry and PediaSat Oximetry Catheters, and the Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor.
Based on the provided text, the submission does NOT include specific acceptance criteria or a study proving the device meets quantitative acceptance criteria in the typical sense for an AI/ML device.
The submission is for a medical device cleared through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria with detailed statistical studies as would be expected for a novel AI/ML algorithm.
Therefore, the following information cannot be extracted directly from the provided document:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence rather than numerical performance against pre-defined criteria.
- Sample size used for the test set and the data provenance: Not present. There is no mention of a "test set" in the context of an AI/ML performance study. The functional testing mentioned is likely for engineering verification and validation of the device hardware and software, not an AI/ML performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth for an AI/ML system is not applicable here as it is not an AI/ML device.
- Adjudication method for the test set: Not present.
- 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 an AI/ML device, so an MRMC study is not relevant and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/ML device, so "standalone algorithm performance" is not relevant and not mentioned.
- The type of ground truth used: Not applicable as this is not an AI/ML device.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.
What is present in the document is a claim of substantial equivalence and successful functional testing:
- Acceptance Criteria (Implicit for 510(k) clearance): Substantial equivalence to predicate devices regarding safety and effectiveness for their intended use.
- Study Proving Acceptance Criteria:
- "The PreSep Oximetry and PediaSat Oximetry Catheters, dilator and the Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor have been demonstrated to be as safe and effective as the predicate devices for their intended use."
- "The PreSep Oximetry and PediaSat Oximetry Catheters, dilator and the Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices."
In summary, the provided text describes a traditional medical device submission (catheters and a monitor) and not an AI/ML device. Therefore, the specific criteria requested for an AI/ML performance study are not found in this document. The "study" mentioned is the functional testing and comparative analysis to predicate devices to establish substantial equivalence for 510(k) clearance.
§ 870.1230 Fiberoptic oximeter catheter.
(a)
Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.(b)
Classification. Class II (performance standards).