(14 days)
The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.
The EDAC™ QUANTIFIER is a standalone system in which the ultrasonic sensing system consists of a three-channel ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers and clamps for attached the transducers to the circuit. This system is currently being certified according to voluntary medical device safety standards UL 60601-1 . IEC 60601-1-2 and IEC 60601-1-4, covering electrical device safety in medical products and IEC-60601-2-37, covering ultrasonic diagnostic safety. It also employs software and firmware to provide the embedded signal processing needed to detect gas emboli over the range of sizes described.
The EDAC™ QUANTIFIER is an ultrasonic cardiopulmonary bypass bubble detector. The study validates the device's ability to detect gaseous emboli in an extracorporeal bypass circuit.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it describes "performance claims" and then details the testing conducted to validate these claims. Based on the "Technological Characteristics Comparison Summary" and the "Non-clinical Testing" section, the following can be inferred as the performance claims (which act as acceptance criteria) and the reported performance.
| Acceptance Criteria (Performance Claim) | Reported Device Performance |
|---|---|
| Detection Sensitivity: Detect microemboli at least 10 microns in diameter. | Detect emboli from 10 microns in diameter up to the diameter of the EDAC™ QUANTIFIER connector (1/2" dia.). |
| Detection Rate: Provide count rates up to at least 1000/sec. | Provides counts rates up to at least 1000/sec. |
| Monitoring Locations: Monitor gas emboli at multiple locations on the bypass circuit. | Up to three simultaneously measured locations. |
| Tubing Compatibility: Compatible with various common arterial tubing sizes. | Sensors are clamped to polycarbonate connectors for insertion into tubing with inner diameters of 1/4", 3/8", and 1/2". |
| Fluid Compatibility: Detect gas emboli in clear fluid and blood of all physiologic hematocrits. | Performance validated using a 28% glycerin solution to mimic blood, canine blood, and a crystalloid solution. |
| Operational Duration: Ability to operate over a full 6-hour surgery. | Tests performed to validate functional claims such as the ability to operate over a full 6-hour surgery. |
| Flow Rate: Operate effectively within a specified flow rate range. | 2.0 L/minute - 6.0 L/minute. |
| Data Provided: Real-time and/or archive data for various parameters. | Provides: Detected emboli tracks (Time vs. Range), COUNT (1-second interval), ESTIMATE volume (1-second interval), SUM (total/average counts & volumes), CHART (1-second count/volume for 5 minutes), User-adjustable alarm/warning, Size distributions into user-selected bins, Embolic load per time interval. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "extensive non-clinical testing" and refers to a "System Test Plan (Attachment 5.7)" which would contain specific details, but this attachment is not provided.
- Data Provenance: The testing was conducted in a laboratory setting.
- Country of Origin: Not explicitly stated, but the parent company (Luna Innovations Inc.) is based in Blacksburg, Virginia, USA.
- Retrospective or Prospective: Prospective, as the tests were performed specifically to validate the device's performance before marketing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing appears to be based on engineering and scientific measurements of bubble detection and sizing, rather than human interpretation of data for ground truth.
4. Adjudication method for the test set:
Not applicable. The ground truth appears to be based on controlled experimental conditions and expected physical phenomena of bubble generation and detection, not on expert consensus or 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 a standalone bubble detector, not an AI-assisted diagnostic tool that human readers would interpret. Its primary function is automated detection, not to improve human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was performed. The non-clinical testing was conducted to evaluate the EDAC™ QUANTIFIER's performance as a "standalone accessory," focusing on its ultrasonic sensing system and embedded signal processing. The device is designed to detect gas emboli automatically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical testing was established through controlled laboratory conditions using:
- Standardized fluid mimics (28% glycerin solution to mimic blood).
- Biological fluids (canine blood).
- Common medical solutions (crystalloid solution used to prime bypass circuits).
- Presumably, controlled introduction of known sizes and quantities of gaseous emboli into these systems, with measurement of the device's ability to accurately detect and quantify them. The "System Test Plan (Attachment 5.7)" would detail the precise methodology for generating and verifying these "ground truth" emboli.
8. The sample size for the training set:
Not applicable. This device is an ultrasonic sensor with embedded signal processing, not a machine learning or AI model that requires a "training set" in the conventional sense. Its "training" would be more akin to software and firmware development and calibration based on known physical principles and experimental validation.
9. How the ground truth for the training set was established:
Not applicable, as there is no traditional "training set" in the context of machine learning. The device's operational parameters and signal processing algorithms would have been developed and calibrated based on engineering principles and experimental data derived from various types and sizes of bubbles in different fluid environments, but this is not typically referred to as a "training set" for ground truth establishment in this type of device.
§ 870.4205 Cardiopulmonary bypass bubble detector.
(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).