(34 days)
Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.
Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips IntelliSpace Cardiovascular software runs on standard information technology hardware, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.
The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.
IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow-up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available.
The solution supports a remote deployment model.
The provided text is a 510(k) summary for the Philips IntelliSpace Cardiovascular device. It explicitly states that no clinical studies were required or performed to support the equivalence of this device. Therefore, it does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria.
However, the document does contain information about how the device's performance was evaluated, which I can summarize with the disclaimer that it is not a clinical study in the traditional sense outlined in your request.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of precise acceptance criteria with corresponding performance metrics. Instead, it describes general verification and validation activities.
| Acceptance Criteria Category (Derived from document) | Reported Device Performance |
|---|---|
| Functionality Requirements | IntelliSpace Cardiovascular meets all defined functionality requirements. |
| Performance Claims | IntelliSpace Cardiovascular meets all defined performance claims. |
| Safety Testing | Performed, addressing findings from Risk Analysis. (Implied: device is safe) |
| Compliance with Standards | Complied with requirements specified in international and FDA-recognized consensus standards. |
| Equivalence to Predicate | Found substantially equivalent to Philips Xcelera (K061995) in design features, fundamental scientific technology, intended use, and safety and effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for test sets, data provenance, or whether testing was retrospective or prospective. It refers to general "system level tests, performance tests, and safety testing."
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)
This information is not provided because no clinical studies involving ground truth assessment by experts are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 image and information management system, not an AI-assisted diagnostic tool in the sense that would typically require such a study for its clearance as described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a software product designed for image and information management, with human users ("clinicians," "users of the equipment"). A standalone algorithm-only performance study as typically understood for AI diagnostics is not applicable and was not performed. The performance evaluation focused on the system's functionality and its equivalence to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no clinical studies or diagnostic performance evaluations were conducted to establish "ground truth" for diagnostic accuracy, this information is not applicable and not provided. The testing focused on technical and functional verification rather than diagnostic accuracy against a ground truth.
8. The sample size for the training set
This information is not applicable and not provided. The device is not described as an AI/ML system that would require a "training set" in the context of diagnostic algorithm development.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm.
In summary, the Philips IntelliSpace Cardiovascular device (K153022) was cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device (Philips Xcelera K061995) based on non-clinical testing. This non-clinical testing included risk analysis, product specifications, design reviews, and verification and validation activities to ensure the device met its defined functionality and performance requirements and complied with relevant standards. No clinical studies or human performance evaluations were deemed necessary or conducted for its clearance.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).