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Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.

Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.

Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.

Philips Xcelera 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.

Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology,

Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.

Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.

Philips Xcelera 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.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for the Philips Xcelera, focusing on its general description, intended use, and substantial equivalence to predicate devices. It states that "The Philips Xcelera does not introduce new indications for use, nor does the use of the device result in any new potential hazard," and therefore no specific performance acceptance criteria or a study demonstrating adherence to those criteria are mentioned.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, data provenance, or details of expert involvement for ground truth establishment.
3. Adjudication methods.
4. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Details on the type of ground truth used for any hypothetical studies.

The 510(k) summary confirms the device's substantial equivalence based on its features and intended use aligning with existing predicate devices (Philips Medical Systems Harmony and Siemens Medical Systems Inc., LEONARDO syngo Cardiology Workstation), rather than through a detailed performance study against specific acceptance criteria.

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