(89 days)
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
MUSE CV is intended to be used in a hospital environment by trained operators.
MUSE CV is designed for network compatibility to facilitate retrieval and distribution of cardiovascular information.
MUSE CV is designed to interface with other hospital information systems through various communication protocols to support information continuity and results reporting.
MUSE CV can provide serial comparison of cardiovascular information to facilitate review of current and previous records.
MUSE CV can provide serial trending of cardiovascular information to facilitate review of current and previous records.
Through integration with Accusketch (CardioTrace), MUSE aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
The provided text does not contain specific acceptance criteria or a detailed study proving device performance against such criteria for the MUSE Cardiovascular Information System. It focuses on the regulatory submission, intended use, and general safety and effectiveness statement, rather than quantifiable performance metrics.
However, based on the information provided, here's what can be inferred or stated about the study and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., specific accuracy thresholds for measurements, speed metrics, etc.). Instead, it focuses on qualitative measures and equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall Safety and Effectiveness | "The results of these measures demonstrate MUSE CV is as safe, as effective, and performs as well as the predicate devices." |
| Functional Equivalence | "MUSE CV employs the same functional technology as the predicate devices. The only difference being the technological improvements made by manufacturers with respect to speed, performance and reliability." |
| Compliance with Voluntary Standards | "The MUSE CV complies with voluntary standards as detailed in Section 9 Specific Standards and Guidances of this submission." |
| Quality Assurance Measures Applied | Requirements specification review, Risk analysis, Design, software and test plan reviews, Code inspections, Testing on unit level, Software and hardware testing, System Integration testing, Final acceptance testing, Environmental Testing, Safety testing. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for any test set (e.g., number of patient cases, ECGs, angiograms).
- The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
4. Adjudication method for the test set:
- The document does not mention any specific adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document describes the device as a "Cardiovascular Information System" that "aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function." It explicitly mentions that it "employs the same functional technology as the predicate devices" with "technological improvements made by manufacturers with respect to speed, performance and reliability."
- There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
- There is no mention of AI or an effect size of how much human readers improve with AI vs without AI assistance. This device predates widespread AI integration in medical devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes the device as a system that "aids the physician or trained technologist," implying a human-in-the-loop design.
- There is no mention of a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of ground truth used for any evaluations. Given the nature of the system (information management and quantification aid), it's likely that the "objective quantification" refers to established clinical methods and expert interpretation, but this is not detailed.
8. The sample size for the training set:
- The document does not mention a training set or its sample size. This is consistent with the device being an "information system" and not an AI/ML-based diagnostic device in the modern sense. The "testing on unit level," "software and hardware testing," and "system integration testing" suggest traditional software development and validation rather than machine learning model training.
9. How the ground truth for the training set was established:
- As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.