(82 days)
The Vigileo APCO/Oximetry monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates hemodynamic and oxygenation parameters. The DDPT is intended to measure intravascular pressures. It is intended to transmit those pressure readings to both a standard blood pressure monitor and to the Vigileo monitor.
The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.
The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.
The Vigileo APCO/Oximetry monitor is a microprocessor-based instrument which, when connected to a DDPT, continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry). 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 510(k) summary for the Vigileo APCO/Oximetry Monitor and Edwards Dual Disposable Pressure Transducer (DDPT) does not contain the detailed acceptance criteria or the specific study details that prove the device meets these criteria in the way a modern AI/ML device submission would. This submission is from 2005 and for a non-AI/ML medical device, focusing on substantial equivalence to predicate devices based on functional and safety testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will address each point based on the information available and indicate where information is missing or not applicable to this type of submission.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative acceptance criteria in a dedicated table or reported performance metrics from a clinical study for the Vigileo device itself. Instead, the "Comparative Analysis" states: "Both the Vigileo APCO/Oximetry monitor and the DDPT have been demonstrated to be as safe and effective as the predicate devices for their intended uses." This implies that the acceptance criterion was equivalence to the predicate devices in terms of safety and effectiveness, demonstrated through functional and safety testing, not specific performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Safety and effectiveness equivalent to predicate devices | Successfully underwent functional testing and electrical safety testing. Shown to be equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance
Not applicable. This submission describes functional and safety testing, not a clinical study with a test set of patient data in the context of an AI/ML device. There is no mention of patient data being used for a "test set" in the context of performance evaluation. The "functional testing" likely refers to engineering verification and validation without human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not a study involving interpretation of data by experts for a ground truth, this information is not present.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication.
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 device is not an AI-assisted diagnostic tool for human readers. It's a monitor measuring physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone monitor and transducer assembly for measuring physiological parameters. Its performance is inherent in its design and function. The "Functional/Safety Testing" mentioned would assess this standalone performance against engineering specifications and predicate device performance. It's not an "algorithm only" in the sense of an AI/ML model where human-in-the-loop is an option.
7. The type of ground truth used
For the "Functional/Safety Testing," the ground truth would likely be established through:
- Engineering specifications and standards: The device's measurements (e.g., arterial pressure, cardiac output, oxygen saturation) would be compared against known reference values from calibrated equipment.
- Predicate device performance: Performance metrics of the Vigileo were likely compared directly or indirectly to those of the Vigilance monitor and Metracor RODA Monitoring System (predicates for the monitor) and Phoenix Disposable Pressure Transducer (predicate for the transducer). This would involve comparisons of accuracy, precision, and reliability in controlled environments.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a "training set" of data in the common sense. Its "training" is in its engineering design and manufacturing.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of AI/ML. The "ground truth" for its development was based on established principles of physiology, medical device engineering standards, and the performance characteristics of its predicate devices.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).