(356 days)
The Vigileo™ APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as 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 monitor also displays parameters, such as stroke volume and stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo™ APCO/Oximetry Monitor may be used in all settings in which critical care is provided.
The Vigileo™ Arterial Pressure Cardiac Output (APCO)/Oximetry Monitor (Vigileo™ Monitor) is a microprocessor-based instrument. When used with an Edwards FloTrac sensor, the Vigileo™ Monitor is capable of continuously monitoring the following parameters: Cardiac Output (CO); Cardiac Index (CI): Stroke Volume (SV): Stroke Volume Variation (SVV); Systemic Vascular Resistance (SVR); Systemic Vascular Resistance Index (SVRI); Oxygen Delivery (DO2); and Oxygen Delivery Index (DO2I). When used with Edwards Oximetry catheters, the Vigileo™ Monitor is capable of continuously monitoring the following parameters: Central venous oxygen saturation (ScvO2); and, Mixed venous oxygen saturation (SvO2).
The Vigileo™ Monitor, version 3.08, is a microprocessor-based instrument designed for continuous monitoring of hemodynamic parameters and oximetry. The provided text, a 510(k) summary, outlines its acceptance criteria and the studies conducted to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria in a table format for specific performance metrics (e.g., accuracy, precision for CO, CI, etc.). Instead, the acceptance criteria are implicitly stated as demonstrating "substantially equivalent" performance to the predicate device (K103094, Vigileo™ Arterial Pressure Cardiac Output/Oximetry Monitor). The reported device performance is described in terms of successful completion of various tests, confirming this substantial equivalence.
| Parameter/Type of Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| General Performance & Functionality | Substantially equivalent to the predicate device (K103094) in performance and functionality. | "Verification and validation testing was conducted to compare the performance and functionality of the subject and predicate devices. This testing regimen included side-by-side bench, pre-clinical studies, and comparative analysis of clinical data. The Vigileo™ Monitor has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use critical care environments." |
| Functional/Safety Testing | Successful passage of various functional and performance tests. | "The Vigileo™ Monitor has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." |
| Safety and Effectiveness | Safe, effective, and substantially equivalent to predicate devices for intended use in OR and ICU environments. | "The Vigileo™ Monitor has been shown to be safe, effective, and is substantially equivalent to the cited predicate devices for their intended use in the OR and ICU environments." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary mentions "pre-clinical animal studies" and "comparative analysis of clinical data" and "comparison testing of clinical cases" for the test set. However, it does not specify the exact sample size (number of patients, animals, or data points) used for these test sets.
The data provenance is stated as including:
- Bench studies: Likely internal laboratory testing.
- Pre-clinical animal studies: Originating from animal subjects. The country of origin is not specified but typically would be internal to the company or contracted research in a regulated environment.
- Clinical data/cases: Originating from human patients. The country of origin and whether the data was retrospective or prospective is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The study relies on "comparative analysis of clinical data" and "comparison testing of clinical cases" against a predicate device, implying that the ground truth for these clinical cases would have been established through a combination of established clinical methods and the predicate device's measurements.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "comparative analysis" and "comparison testing," which suggests direct comparison of the subject device's outputs with the predicate device's outputs or established clinical reference methods, rather than a human expert adjudication process for image interpretation or diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is a monitor that provides numerical hemodynamic and oximetry parameters, not an imaging device or AI algorithm for diagnosis that would typically involve human readers. The comparative effectiveness focused on the technical performance of the device itself against a predicate, not on how human readers' performance improves with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device is a "Single-Function, Preprogrammed Diagnostic Computer," the term "standalone" in the context of AI often refers to an algorithm making a diagnosis without human input. This device provides physiological measurements to clinicians, rather than a diagnostic interpretation in the way an AI algorithm might. Therefore, the concept of a standalone AI algorithm is not directly applicable here. The device performs its functions (calculating CO, CI, SV, etc.) based on physiological inputs, which is inherently a "standalone" processing of data, but it's not an AI making a medical decision. The primary assessment was device performance and functionality, not an AI algorithm's diagnostic capabilities.
7. The Type of Ground Truth Used
The ground truth for evaluating the Vigileo™ Monitor's performance was established through:
- Comparison to a predicate device (K103094): The primary method of demonstrating substantial equivalence was by comparing the performance and functionality of the subject device against the previously cleared predicate device.
- Established clinical methods/measurements: Implied in the "pre-clinical animal studies" and "comparative analysis of clinical data," the accuracy of the measurements would be referenced against recognized standards or gold standard measurements for cardiac output and oximetry, even if not explicitly detailed in this summary.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a "training set" in the context of machine learning or AI development. This device is a preprogrammed diagnostic computer that likely uses established physiological algorithms, not a machine learning model that requires a training set. Therefore, this question is not applicable in the context of the provided document.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for a machine learning model, the question of how its ground truth was established is not applicable based on the provided information.
§ 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).