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Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information Management/Physiomonitoring 5 and/or 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.

Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The Xper Information Management ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. The Xper ECG Management system does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. The Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The Xper Information Management device is intended to be used for complete physiologic/hemodynamic monitoring and information gathering as well as medical image review through links to cleared devices. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.

The provided text focuses on the 510(k) summary for the Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station, and ECG Management system. It describes the device, its intended use, and states its substantial equivalence to a predicate device based on "Performance Testing as well as the Hazard analysis." However, it does not provide specific acceptance criteria, detailed results from performance tests, or information about specific studies that demonstrate the device meets acceptance criteria.

The document states that the modifications to the device primarily involve:

• Introduction of a new trade name.
• GUI updates.
• Upgrades in hardware and software to facilitate integration of the latest technology.

It explicitly mentions that the modified device has the "same technological characteristics as the legally marketed predicate device (K033030)." This strongly suggests that the focus of the 510(k) submission was on demonstrating that these changes did not adversely affect the device's fundamental safety and effectiveness, rather than performing entirely new clinical or detailed performance studies against novel acceptance criteria.

Therefore, for most of the requested information, the answer will be that the details are not available in the provided text.

Here's an attempt to answer the questions based on the available information:

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

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

Not provided in the document. The text refers to "Performance Testing" and "Hazard analysis" but does not detail the nature of these tests, the data sources, or sample sizes.

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 provided in the document. This type of information would typically be detailed in a more comprehensive clinical study report, which is not part of this 510(k) summary. Given the nature of the device (physiomonitoring and information management, not diagnostic interpretation), "ground truth" in the diagnostic sense might not be applicable in the same way as for an AI-powered diagnostic tool. The document states "Its users, responsible to interpret the data made available, will be professional health care providers."

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

Not provided in the document.

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

Not done. This device is described as a physiomonitoring and information management system, not an AI-assisted diagnostic tool that aids human readers in interpretation. The document explicitly states for the ECG Management System that it "does not provide interpretive functions."

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

Not applicable in the context of this device as described. The device "facilitates clinical data acquisition and analytical assessment" and its "users, responsible to interpret the data made available, will be professional health care providers." The ECG Management System "does not provide interpretive functions."

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

Not explicitly stated. Given that the device handles "physiologic/hemodynamic monitoring" and "clinical data acquisition," the "ground truth" for its performance would likely relate to the accuracy of physiological measurements, data integrity, system functionality, and adherence to safety standards. However, the document does not specify how this "ground truth" was established for testing purposes.

8. The sample size for the training set

Not applicable/Not provided. This device is not described as an AI/ML device that requires a training set in the conventional sense for learning patterns or making predictions. It's a system for managing and displaying physiological data.

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

Not applicable/Not provided. As above, this is not an AI/ML device requiring a training set with established ground truth for learning.

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