(144 days)
The Bard Borealis (CLEARSIGN) Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the Bard LabSystem III EP Laboratory) that can record and display the information.
The Borealis Amplifier is a medical device intended to collect, amplify, filter and format physiological signals for transfer to a host computer system (Bard Electrophysiologic LabSystem III Laboratory) capable of recording and display of such information. The physiologic signal information is acquired from diagnostic and therapeutic electrophysiology (EP) catheters, surface electrocardiographic (ECG) electrodes, intravascular pressure transducers, intracardiac stimulators and RF ablation generators.
The provided text describes the "Borealis Amplifier" and states that "Software qualification is performed on the system according to specific acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the Borealis Amplifier" and "The testing demonstrates that the Borealis Amplifier meets the established performance requirements." However, the document does not explicitly list the acceptance criteria or the specific device performance outcomes for these criteria. It focuses on demonstrating substantial equivalence to a predicate device (STAMP Amplifier) through adherence to various electrical safety and compatibility standards, and general software quality assurance.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's what can be answered and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Not explicitly listed. The document states "Software qualification is performed on the system according to specific acceptance criteria" and "The testing demonstrates that the Borealis Ampifier meets the established performance requirements," but the criteria themselves and the specific outcomes are not detailed. | Not explicitly detailed for specific performance metrics, but generally stated that the device "meets the established performance requirements" and testing confirmed "safety and effectiveness of each functional aspect." |
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: Not specified. The document mentions "testing conducted in support of the Borealis Amplifier" and reports in Volume II (appendices), but does not detail sample sizes for specific functional tests.
- Data Provenance: Not specified. The document does not indicate the country of origin of testing data, nor whether it was retrospective or prospective. The testing appears to be primarily laboratory-based to meet engineering and safety standards, rather than clinical trial data.
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)
- Not applicable. The document discusses non-clinical tests (electrical safety, EMC, software qualification) for an amplifier device. These types of tests typically rely on engineering specifications and measurement equipment, not expert consensus for ground truth on clinical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As noted above, the tests are primarily engineering and technical, not clinical evaluations requiring adjudication of ground truth by multiple experts.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an amplifier for physiological signals, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the device as collecting, amplifying, filtering, and formatting physiological signals for transfer to a host computer for recording and display. It explicitly states: "The system does not control the delivery of therapy, it does not administer drugs, it does not perform any life-supporting or life-sustaining functions, and it does not analyze data acquired during an EP procedure." Therefore, its performance is inherently standalone in its function as an amplifier, without a "human-in-the-loop" component for its primary operation. The testing conducted focused on its technical compliance to standards (electrical safety, EMC, software verification) rather than an assessment of diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests described, the "ground truth" would be the engineering specifications and compliance requirements outlined in the various international standards (e.g., EN 60601-1, IEEE standards for software). For instance, for electrical safety, the ground truth is whether the device's electrical leakage or insulation meets the specified limits in the standard.
8. The sample size for the training set
- Not applicable. This document describes a medical device (an amplifier) and its compliance testing, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).