(140 days)
The CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM's beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious sedated patients in the operating room, intensive care unit, emergency room or ward.
The CardioQ-EDM system employs esophageal Doppler techniques using 4 MHz continuous thoracic aorta, displaying this data as a maximum velocity curve, a descriting there is derived measurements. Thus, real-time information about verouty opesant in particular left ventricular flow, is displayed continuously. This is the same as for the predicate CardioQ K031706. CardioQ-EDM is an enhancement of the CardioQ K031706; obsolete The components have been replaced and an improved/modernized user interface created, by utilizing the full capabilities of the new components.
The provided text describes a 510(k) premarket notification for the Deltex Medical CardioQ-EDM Esophageal Doppler Monitor, aiming to demonstrate substantial equivalence to a predicate device (Deltex Medical CardioQ - K031706). Since it's a 510(k) submission, the "acceptance criteria" are implied by comparing the new device's performance to the legally marketed predicate device, rather than explicit numerical thresholds typically seen in AI/ML performance studies. The study described is a comparative bench study.
Here's the breakdown of the information requested based on the provided text, recognizing that it's a medical device submission focused on substantial equivalence rather than AI/ML performance:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, acceptance criteria are generally to demonstrate that the new device (CardioQ-EDM) performs as safely and effectively as the predicate device (CardioQ K031706). The "reported device performance" is the conclusion of the bench testing that substantial equivalence was achieved. Specific numerical acceptance criteria are not explicitly stated for individual device parameters, but rather the overall conclusion of comparable performance across all listed characteristics.
| Feature/Parameter | Acceptance Criteria (Implied - substantial equivalence to predicate) | Reported Device Performance (CardioQ-EDM) |
|---|---|---|
| Indications for Use | Same as predicate (with minor textural updates) | Same as predicate |
| Patient Population | Same as predicate | Same as predicate |
| Patient Status | Same as predicate | Same as predicate |
| Insertion Route | Oral or Nasal | Oral or Nasal (predicate was Oral, Nasal added later) |
| Contraindications | Same as predicate | Same as predicate |
| System Design | Same as predicate | Same as predicate |
| System Components | Functionally equivalent/improved as predicate | Updated components, modernized user interface |
| Mode of Operation | Same as predicate | Same as predicate |
| Ultrasonic Clutter Rejection | Same as predicate | Same as predicate |
| Spectral Display | Same as predicate | Same as predicate |
| Velocity Spectrum Display Time Range (x-axis) | Performance comparable to predicate | Full screen: 4.3 seconds (Predicate: 3.6 sec) |
| Split screen: 1.4 seconds (Predicate: 1.4 sec) | ||
| Velocity Display Scales (y-axis) | Performance comparable to predicate | 50, 100, 200 cm/s, 250 cm/s (Predicate: 50, 100, 200 cm/s) |
| Doppler Audio Confirmation | Same as predicate | Same as predicate |
| Display | Performance comparable to predicate | Color 10.4" TFT LCD screen (800 x 600 pixels) (Predicate: 640 x 480 pixels) |
| Ranges of Directly Measured Parameters | Comparable to or improved from predicate | Peak Velocity (PV) 10 - 250 cm/s (Predicate: 10 - 220 cm/s) |
| Other parameters same range | ||
| Ranges of Calculated Parameters | Same as predicate | Same as predicate |
| Operating Modes | Same as predicate | Same as predicate |
| Controls & User Interface | Performance and functionality comparable to predicate | Similar controls with updated implementation |
| Parameters Displayed | Performance comparable to predicate, with potential for improvement/increase of displayed parameters | Eight of listed parameters displayed (Predicate: Six) |
| Parameters Update Rate | Same as predicate | Same as predicate |
| Trend History | Performance comparable to or improved from predicate | Up to 240 hours/Unlimited (Predicate: Up to 48 hours) |
| Trend Temporal Resolution | Same as predicate | Same as predicate |
| Acoustic Output | Compliance with NEMA UD 2 | Compliant with NEMA UD 2 |
| Electrical Safety & EMC | Compliance with IEC 60601 series | Compliant with IEC 60601 series |
| Overall Performance | Substantially equivalent to predicate | Substantially equivalent performance achieved |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This was a bench testing study, therefore there is no "patient test set" in the traditional sense. The comparison was between the physical device (CardioQ-EDM) and the predicate device (CardioQ K031706) within a laboratory/bench environment. The text does not specify a "sample size" of individual tests or measurements, but rather refers to "Comparative bench testing of the CardioQ-EDM... using a CardioQ..."
- Data Provenance: The study was conducted by Deltex Medical Limited, based in the United Kingdom. The data is from bench testing, implicitly a prospective assessment of the new device's engineering and performance characteristics against the predicate's known specifications and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of device (a diagnostic/monitoring tool) and study (bench testing for substantial equivalence), "expert ground truth" as understood in clinical evaluation or AI/ML performance is not relevant. The "ground truth" for the bench testing would be the engineering specifications and validated performance characteristics of the predicate device, against which the new device's measurements and functionalities were compared. This would be established by experts in device design, testing, and regulatory compliance, but not in the sense of clinical annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. This concept is not applicable to bench testing where objective measurements and engineering specifications are compared. Discrepancies would be resolved through engineering re-evaluation or re-testing, not through a consensus-based adjudication of clinical observations.
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
- No, an MRMC study was NOT done. This submission is for a medical device (Esophageal Doppler Monitor), not an AI/ML diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant. The device measures physiological parameters, and its performance is assessed against directly measured physical quantities or established specifications.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the context of AI/ML algorithms. The CardioQ-EDM is a standalone medical device that provides direct measurements and calculated parameters. Its "standalone performance" refers to its ability to accurately measure and compute these physiological metrics as designed, compared to the predicate device. It's not an AI algorithm that processes data to generate a finding that a human then interprets or acts upon.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the bench testing was primarily the engineering specifications and established performance characteristics of the predicate device (CardioQ K031706), along with compliance with recognized consensus standards (IEC 60601 series for electrical safety/EMC, NEMA UD 2 for acoustic output). The goal was to show that the new device met or exceeded these, demonstrating substantial equivalence.
8. The sample size for the training set
- Not applicable. This submission is for a medical device that does not use machine learning algorithms, thus there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth established for it.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).