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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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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 providing patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

The MUSE Cardiology Information System is a network PC-based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing 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 device 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.

The provided text is a 510(k) Premarket Notification Submission for the GE Healthcare MUSE Cardiology Information System. This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information on specific acceptance criteria and a study proving device performance in the way typically found for novel AI/ML devices.

However, based on the provided text, here's what can be extracted and inferred regarding the "acceptance criteria" for this specific submission:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a system that leverages existing technology and claims substantial equivalence, the "acceptance criteria" are primarily related to general safety, effectiveness, and functional comparability to its predicate device, rather than specific performance metrics (like sensitivity, specificity, or AUC) for a new algorithm.

• IEC 60601-1-1:2001 (Medical Electrical Equipment - General Requirements for Safety)
• IEC 60601-1-2:2007 (Electromagnetic Compatibility)
• IEC 60601-1-4:2000 (Programmable Electrical Medical Systems)
• ISO 14971:2009 (Risk Management to medical devices) |
  | Quality Assurance Measures | Applied:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Code Inspection
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation) |
  | Functional Equivalence to Predicate | "The proposed MUSE Cardiology Information System employs the same functional scientific technology as the predicate device MUSE Cardiovascular Information System (K110132)." |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document explicitly states: "The subject of this premarket submission, MUSE Cardiology Information System, did not require clinical studies to support substantial equivalence." Therefore, no specific test set sample size or data provenance is mentioned as part of a formal clinical study for this submission. The testing mentioned in the Quality Assurance Measures (e.g., performance testing, simulated use testing) would have involved internal validation, but details about sample size or data provenance for these internal tests are not provided in this public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no clinical studies were required and no specific "test set" with a delineated ground truth is mentioned in the context of proving performance against clinical endpoints, this information is not available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

No adjudication method is mentioned, as no clinical test set requiring this was conducted for supporting substantial equivalence.

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 MRMC comparative effectiveness study was performed or cited in this submission. The device is an "ECG Analysis Computer" and "Cardiology Information System" which provides tools for review and editing, including interpretive 12-lead analysis. The submission focuses on its system capabilities and equivalence to its predicate, not on a human-AI collaborative performance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device description mentions "interpretive 12-lead analysis," which implies an algorithm that performs analysis. However, the submission does not detail any standalone performance study of this algorithm. The overall device is a system that allows reviewing and editing by trained operators under the supervision of a licensed healthcare practitioner. The focus of the submission is on the system's ability to store, access, and manage cardiovascular information, leveraging the same functional scientific technology as its predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. Given that no formal clinical study was required for this submission, there is no mention of how "ground truth" would have been established for performance evaluation (e.g., for the interpretive 12-lead analysis component).

8. The sample size for the training set:

Not applicable or not provided. This submission is for a system that uses "the same functional scientific technology" as its predicate. It does not describe a new AI/ML algorithm that would undergo a separate training process requiring a specific training set size to be detailed in this type of submission.

9. How the ground truth for the training set was established:

Not applicable or not provided, for the same reasons as in point 8.

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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, 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 providing patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

The MUSE Cardiology Information System is a network PC- based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing 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 device 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.

The provided document, K110132, for the GE Healthcare MUSE Cardiology Information System, does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is a 510(k) Premarket Notification Submission based on substantial equivalence.

The summary explicitly states:

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

Therefore, I cannot provide the requested table or details about a study demonstrating the device meets acceptance criteria derived from this document. The submission relies on demonstrating that the new device employs the same functional and scientific technology as its predicate devices (MUSE Cardiology Information System K#072502 and MUSE Cardiology Information System w/ VMWare K#083639) and complies with voluntary standards and internal quality assurance measures.

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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. 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 is intended to store, access and manage cardiology information on adult and pediatric patients. MUSE Cardiology Information System has been marketed to operate within Microsoft Windows Operating System (OS) directly interacting with the host hardware. GE Healthcare intends to change this interaction by running MUSE Cardiology Information System with an Off the Shelf virtualization software layer. GE feels that this proposed change alters the principal of operation of the Operating System. This proposed change will be marketed as a software only offering, which will utilize an OTS software that virtualizes the host hardware. This will allow multiple OS shells to run on a single hardware server, one of which is the OS hosting the predicate MUSE Cardiology Information System program.

The MUSE Cardiology Information System is a network PC based system comprised of a client workstation /servor configuration that manages adult and pediatric diagnosis cardiology data by providing centralized storage and ready access U:Ree) from OF HiRes) from GE and non-GE diagnostic and monitoring equipment.

The device 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
• To generate formatted management reports, ad-hoc . database search reports and clinical patient reports on selected stored data.

This 510(k) submission, K083639, for the "MUSE Cardiology Information System with VMWare" from GE Healthcare, describes a software-only offering that virtualizes the host hardware for an already marketed device (K072502).

Here's an analysis of the acceptance criteria and study described:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of acceptance criteria or reported device performance in the traditional sense of a clinical or analytical performance study. This is because the submission states:

• "The subject of this premarket submission, MUSE Cardiology Information System with VMWare, did not require clinical studies to support substantial equivalence."

Instead, the acceptance criteria implicitly relate to the demonstration that the new configuration (running the MUSE system with VMWare) is as safe and effective as the predicate device (MUSE Cardiology Information System, K072502). The "performance" in this context refers to the system's intended functions remaining unchanged when operating within the virtualized environment.

The submission focuses on quality assurance measures and non-clinical tests to establish substantial equivalence. These implicitly serve as the "acceptance criteria" for the change being proposed.

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 applicable / Not mentioned. This submission did not involve a clinical or performance study with a test set of patient data to evaluate algorithmic performance. The evaluation was primarily engineering-based and focused on the safety and functionality of the software change.
• Data Provenance: Not applicable / Not mentioned for a test set.

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. No patient data test set requiring expert ground truth was described or used in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No patient data test set requiring adjudication was described or used in this submission.

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 MRMC comparative effectiveness study was done. The device is an information system, not an AI-powered diagnostic tool that assists human readers in interpreting clinical data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This submission describes a software architectural change (virtualization) for an existing information system. It is not an AI algorithm with standalone performance in the typical sense. The "standalone" performance being assessed is the system's ability to continue performing its intended functions (storing, accessing, managing cardiology information, reviewing, editing ECG procedures) within the virtualized environment as it did in the non-virtualized environment. This was established through the non-clinical testing listed (unit, integration, acceptance, performance, safety testing).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the context of clinical ground truth for a diagnostic algorithm. The "ground truth" for this submission was the established functionality and safety of the predicate device (MUSE Cardiology Information System, K072502) in its original operating environment. The non-clinical tests aimed to prove that this "ground truth" of functionality and safety was maintained after the virtualization change.

8. The sample size for the training set

• Not applicable. This submission does not describe an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set was described or used.

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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. 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 is a network PC-based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing 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 device 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.
To generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data.
This modification will provide the capability to generate median waveforms and ECG measurements from 12-lead ECG data received in a GE specified XML format. Other added functionality includes an additional QTc calculation method, a refined tool (Interval Editor) to manually measure, review, and document ECG waveform parameters, and workflow enhancements.

The provided document, K072502, a Special 510(k) Premarket Notification for the GE Healthcare MUSE Cardiology Information System, focuses on demonstrating substantial equivalence to a predicate device (K050614) after a modification. This type of submission typically emphasizes non-clinical testing and conformity to standards rather than detailed clinical study data with specific acceptance criteria for performance metrics.

Based on the provided text, the document states: "Based on the results of the performed testing it is concluded that the MUSE Cardiology Information System with the modifications subject to this submission is substantially equivalent to and is as safe, as effective, and performs as well as the currently marketed predicate device cleared in K050614."

This indicates that the "acceptance criteria" for this specific submission is primarily demonstration of substantial equivalence through non-clinical testing and adherence to quality assurance measures, rather than meeting specific quantifiable performance thresholds for clinical accuracy or efficacy.

Therefore, a table of acceptance criteria and reported device performance in the clinical sense is not explicitly provided in this document as it would be in an original 510(k) or PMA that introduces a novel analytical capability. The focus is on the impact of the modification to an already cleared device.

However, I can extract information related to the "study" (testing) that proves the device meets the implicit criterion of substantial equivalence.

1. A table of acceptance criteria and the reported device performance

As noted above, explicit quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a specific disease detection) and corresponding reported performance are not provided in this 510(k) summary. The acceptance criterion for this modification is largely qualitative: proving the modified device is as safe, effective, and performs as well as the predicate.

The document lists the following quality assurance measures and performance testing as the "study" demonstrating this:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical testing (risk analysis, requirements reviews, design reviews, integration testing, final acceptance testing, performance testing). It does not mention a clinical test set or sample size in the context of clinical performance evaluation. Therefore, information regarding data provenance (country of origin, retrospective/prospective) for a clinical test set is also not provided.

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)

Given that no clinical test set is described, there is no mention of experts used to establish ground truth for such a set in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since no clinical test set is described, no adjudication method for a clinical test set is mentioned.

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 MRMC comparative effectiveness study was mentioned or performed according to this document. The submission is for a modification of an existing system, not the introduction of AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe the evaluation of a standalone algorithm's performance in the context of clinical diagnostic accuracy. The testing mentioned (integration, acceptance, performance testing) refers to the functionality of the system modifications, not a new diagnostic algorithm. The device itself is described as an "ECG Analysis Computer," implying an algorithm component, but its standalone diagnostic performance is not the subject of the testing reported here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the focus on non-clinical testing for system modifications, no specific type of clinical ground truth (like expert consensus, pathology, or outcomes data) is mentioned as being used for performance evaluation in this document.

8. The sample size for the training set

The document describes non-clinical testing for a system modification. There is no mention of a "training set" in the context of machine learning or algorithm development.

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 its ground truth would have been established.

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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. 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.

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