(26 days)
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
The MUSE Cardiology Information System comprises a client workstation/server configuration whose purpose is to manage diagnostic cardiology data. The MUSE Cardiology Information System is a network PCbased system that provides centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment.
The provided 510(k) summary for the "MUSE Cardiology Information System" does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a specific study proving the device meets acceptance criteria in the manner requested.
The document is a general 510(k) submission summary, primarily focused on establishing substantial equivalence to a predicate device (K992637) and outlining the general development and testing processes. It lacks specific quantitative performance metrics, detailed study designs, or ground truth establishment methods for a clinical evaluation.
Here's a breakdown of what is and isn't present in relation to your request:
Information NOT Found in the Document:
- A table of acceptance criteria and the reported device performance: The document states that "The results of these measurements demonstrated that the MUSE Cardiology Information System is as safe, as effective, and performs as well as the predicate device," but it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance data to back this claim.
- Sample sizes used for the test set and the data provenance: No information on the number of cases or the nature of the data (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and their qualifications: No details about experts for ground truth.
- Adjudication method: No information provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No mention of such a study or an effect size. The focus is on a system for managing data, not an AI for interpretation.
- Standalone (algorithm-only) performance: As this is an information system for managing and reviewing ECG data, rather than an automated diagnostic algorithm, the concept of "standalone performance" in the AI sense isn't directly applicable for an interpretation algorithm. The system itself is "standalone" in its function of data management.
- Type of ground truth used: No specific mention of ground truth types (e.g., expert consensus, pathology, outcome data) that would typically be associated with an AI diagnostic device.
- Sample size for the training set: Not applicable as this is not an AI/ML diagnostic algorithm.
- How the ground truth for the training set was established: Not applicable.
What the Document Does Mention Regarding "Testing":
The document lists "Test Summary" items, which are related to software development and validation best practices, rather than a clinical performance study evaluating diagnostic accuracy. These include:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration Testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental Testing
- Conclusion: "The results of these measurements demonstrated that the MUSE Cardiology Information System is as safe, as effective, and performs as well as the predicate device."
Summary of Device and its Purpose:
The MUSE Cardiology Information System is described as a "network PC-based system that provides centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment." Its primary function is to "store, access and manage cardiovascular information" and "provide the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison."
It clearly states: "The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison."
Conclusion Based on the Provided Information:
Based solely on the provided 510(k) summary, it's not possible to provide the requested detailed information regarding acceptance criteria and a specific study proving the device meets them in the context of diagnostic accuracy or AI performance. The document focuses on the system's ability to manage, store, and display cardiology data comparably to a predicate device, and its safety and effectiveness are confirmed through general software validation and testing rather than a clinical performance study with defined ground truth and statistical endpoints for diagnostic performance.
This device predates the widespread regulatory focus on AI/ML-driven diagnostics, and its 510(k) summary reflects regulatory requirements for a data management system rather than an automated diagnostic tool.
§ 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).