(92 days)
The FusedCO Algorithm when used with Edwards' Swan-Ganz advanced technology pulmonary artery catheter and Acumen IQ sensor is indicated for use in adult critical care patients requiring of cardiac output and derived hemodynamic parameters in a hospital environment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.
The FusedCO algorithm is a cardiac output (CO) algorithm available when operating with an Edwards' Swan-Ganz advanced technology pulmonary artery catheter and Acumen IQ sensor. The FusedCO algorithm uses cardiac output signals from a Swan-Ganz advanced technology pulmonary artery catheter and an Acumen IQ sensor (arterial line) to provide a fused cardiac output (FusedCO) and its derived parameters, cardiac index (CI), stroke volume (SV) and stroke volume index (SVI), every 20 seconds.
Here's an analysis of the acceptance criteria and study information for the FusedCO Algorithm, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it refers to the device having the "same performance specifications for the cardiac output measurement as the predicate device (K180881)."
| Metric/Characteristic | Acceptance Criteria (from predicate device K180881) | Reported FusedCO Algorithm Performance |
|---|---|---|
| Cardiac Output (CO) Measurement Performance | Same as predicate device (K180881) | "FusedCO algorithm passed all testing." |
| Parameter Update Rate | N/A (Predicate: 5-7 seconds for Swan-Ganz, 20 seconds for Acumen IQ) | 20 seconds (improved over Swan-Ganz alone) |
Note: Without access to the predicate device's 510(k) submission (K180881), the specific numerical acceptance criteria for cardiac output measurement performance cannot be fully detailed. The statement "FusedCO algorithm passed all testing" suggests that it met the required performance standards, which are implied to be aligned with the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "patient data, including cardiac output from a Swan-Ganz advanced technology pulmonary artery catheter and arterial pressure waveforms."
- Data Provenance: Retrospective. The data was "collected retrospectively." The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The method for establishing ground truth is mentioned, but not the number or qualifications of experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly stated. The document describes "Algorithm Verification" and "Software verification" using patient data but does not mention a comparative effectiveness study involving human readers with and without AI assistance. The focus is on the algorithm's performance against reference data.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The "Algorithm Verification" section states: "The FusedCO algorithm performance was tested to ensure the safety of the device. The verification of the FusedCO algorithm was performed using patient data... The FusedCO algorithm passed all testing." This indicates testing of the algorithm itself without human interaction.
7. Type of Ground Truth Used
- The ground truth for the test set was established using "cardiac output from a Swan-Ganz advanced technology pulmonary artery catheter and arterial pressure waveforms." These are standard clinical measurement modalities. While not explicitly termed "expert consensus," these are considered the reference methods for measuring cardiac output in clinical settings, implying that values from these sources serve as the ground truth.
8. Sample Size for the Training Set
- The sample size for the training set is not explicitly stated. The document mentions that the algorithm uses existing data by fusing cardiac outputs from different sources, but it doesn't separate training data from verification data or provide sizes for either. The phrase "collected retrospectively" generally refers to the data used for verification/testing rather than an explicitly defined training set.
9. How Ground Truth for the Training Set Was Established
- This information is not explicitly stated for a dedicated training set. Given that the algorithm fuses existing cardiac output signals from a "Swan-Ganz advanced technology pulmonary artery catheter and an Acumen IQ sensor (arterial line)," it's implied that these established clinical measurement methods constitute the "ground truth" or reference data for both training (if applicable) and verification. The document doesn't detail a separate process for establishing ground truth specifically for training data beyond these established measurement techniques.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).