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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 and interpretive 12-lead analysis. 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 patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediativ serial comparison.

The MUSE Cardiology Information System is a network based cardiology information management system that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data types and reports from GE and non-GE data acquisition devices. The MUSE Cardiology Information System provides the ability to: Review and edit stored data consisting of measurements, text, and digitized waveforms on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead analysis. Generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data. Translates and transfers patient demographic and administrative data from EMR/HIS systems to clinical acquisition devices and translates and transfers tests results from clinical acquisition devices to EMR/HIS systems. Configurable workflow capabilities for managing administrative and clinical tasks in the diagnostic cardiology department, including order/patient demographic management, clinical test review/edit, clinical report distribution, and billing.

This looks like a 510(k) summary for the MUSE Cardiology Information System (K152993). Based on the provided document, here's an analysis of the acceptance criteria and supporting studies, or lack thereof:

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data typical of PMA submissions.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria or quantitative performance metrics for the MUSE Cardiology Information System and its features (like ECG serial comparison or interpretive 12-lead analysis).

Instead, the submission focuses on demonstrating that the subject device (MUSE Cardiology Information System K152993) has the same technological elements and intended use as its predicate device (MUSE Cardiology Information System K130155 and 12SL ECG Analysis Program K141963).

The "performance" is implicitly demonstrated by the claim of substantial equivalence to the predicate device, which is already legally marketed and presumed to have acceptable performance.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "The subject of this premarket submission, MUSE Cardiology Information System, did not require clinical studies to support substantial equivalence."

This indicates that there was no specific clinical "test set" used for a performance study of the new device features directly. The evaluation appears to be based on a comparison to the predicate device and internal testing of software functionality and safety.

Therefore, sample size and data provenance for a clinical test set are not applicable here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Given that explicit clinical studies with a designated "test set" to establish new performance metrics were not required or conducted for this 510(k) submission, information about experts for ground truth establishment is not provided.

4. Adjudication Method for the Test Set:

As no explicit clinical test set requiring ground truth establishment was conducted for the new device as part of this submission, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a MRMC comparative effectiveness study. The focus is on demonstrating equivalence, not on comparing the new device's performance with human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document does not describe a standalone performance study for the algorithm (e.g., the 12SL ECG Analysis Program within MUSE) in isolation. The device is a "Cardiology Information System" intended for use under the direct supervision of a licensed healthcare practitioner, implying human-in-the-loop operation. The 12SL ECG Analysis Program provides "computerized measurements and interpretive diagnostic statements that assist the physician interpreting the ECG," indicating an assistive role rather than a standalone diagnostic role for the system's output.

7. Type of Ground Truth Used:

Since clinical studies to establish new performance metrics were not conducted for this submission, there's no mention of the type of ground truth used for such a study.

For the predicate device's 12SL ECG Analysis Program (K141963), it is generally understood that such interpretive algorithms would have been developed and validated against a ground truth established by expert cardiologists' interpretations of ECGs, possibly correlated with clinical outcomes or pathology in historical training/validation sets. However, this document does not detail the predicate's ground truth.

8. Sample Size for the Training Set:

The document does not specify a sample size for a training set. As mentioned, no new clinical studies for performance were conducted as part of this submission. Any training sets would have been associated with the development of the embedded 12SL ECG Analysis Program, which is a component inherited from the predicate. Details of the training sets for these pre-existing components are not typically included in a 510(k) for an information system unless significant modifications to the analytical algorithms are being introduced and require re-validation.

9. How Ground Truth for the Training Set Was Established:

Similar to point 8, the document does not provide details on how ground truth was established for any training set. This information would pertain to the development of the analytical algorithms (like the 12SL program) that the MUSE system incorporates, rather than the information system itself.

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