(70 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 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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional intent remains the same as predicate device (K072502). | "The functional intent of MUSE Cardiology Information System with VMWare will remain the same as the premarket notification reviewed in 2007 (K072502)." The device provides the ability to review and edit stored data, generate reports, and manage cardiology data as described for the predicate. |
| Compliance with voluntary standards. | "The MUSE Cardiology Information System with VMWare and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission." (Specific standards not detailed in the provided text). |
| Quality assurance measures applied to development. | Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing (Verification), Safety testing (Verification) were all applied. |
| Safety and effectiveness are substantially equivalent to predicate. | "GE Healthcare considers the MUSE Cardiology Information System with VMWare to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." This is the conclusion drawn from the non-clinical work. |
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.
§ 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).