(80 days)
The Vigilance CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.
The Vigilance CCO/SvO2/CEDV Monitor is a microprocessor-based instrument which, when connected to an Edwards thermodilution catheter, measures cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO), as well as continuously generates right ventricular ejection fraction (EF) and end diastolic volume (EDV). When connected to an Edwards oximetry catheter, the monitor measure oxygen saturation (oximetry).
The provided text describes a 510(k) premarket notification for the Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel performance studies with acceptance criteria and ground truth.
Therefore, the document does not contain the specific information required to fill out all requested sections about acceptance criteria and detailed study parameters for a new device. The document primarily states that the device has been shown to be substantially equivalent to its predicate devices through functional and safety testing.
However, I can extract the information that is present and explain why other sections cannot be completed based on the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for specific performance metrics of the new Vigilance CCO/SvO2/CEDV Monitor compared to its reported performance. Instead, it states:
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | "Demonstrated to be as safe and effective as the predicate devices for its intended use." | "Effectiveness as the predicate" |
| Functional Testing | "Successfully undergone functional testing" | "Passed functional testing" |
| Electrical Safety Testing | "Successfully undergone electrical safety testing" | "Passed electrical safety testing" |
| Equivalence to Predicate | "Equivalent to the predicate device." | "Equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for any test set or the data provenance (country of origin, retrospective/prospective).
- The Comparative Analysis section only states general safety and effectiveness. The Functional/Safety Testing section indicates that the device underwent these tests, but no details about clinical or performance study sample sizes are 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)
- The document does not mention any experts used to establish ground truth for a test set, nor does it describe their qualifications. This type of detail is not typically found in a 510(k) summary focused on substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- The document does not mention any adjudication method for a test set. This is not applicable given the nature of the information provided.
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
- The Vigilance CCO/SvO2/CEDV Monitor is a medical device for measuring cardiac parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device performs measurements (CCO, SvO2, CEDV, EF). It is a standalone "microprocessor-based instrument" that connects to catheters. The "algorithm only" concept typically applies to software-based diagnostic tools. This device directly measures physiological parameters.
- The document implies that the device's functional performance was evaluated, which would inherently be its standalone performance since it's a measuring instrument. However, detailed results of this "standalone" performance against a gold standard are not provided in this 510(k) summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document does not specify the type of ground truth used. For a device measuring physiological parameters like cardiac output, ground truth would typically be established by a highly accurate reference method or another validated device. However, this is not detailed in the provided summary.
8. The sample size for the training set
- The document does not mention a training set. This is not applicable as the device is a measurement instrument, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- This question is not applicable as there is no mention of a training set for this device.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).