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The AXIOM Sensis system is intended for use as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools.
The AXIOM Sensis system has functions for:

• External communication via the DICOM interface by using Siemens Medical Platform 1. syngo ™and AXIOM Sensis VC00A DICOM Conformance Statement
• External Communication via the HL7 interface by using AXIOM Sensis Interface description 2: · HL7 Interface.
• 3. Local communication by using the Siemens HICOR interface
• Local communication by using the Siemens AXIOM Artis FC/BC interface 4.
• Local communication with Medtronic Model 4803, Atakr® II RF Power Generator, Boston ર. Scientific EP Technologies EPT-100 TC. and Stockert EP-Shuttle Ablator devices

AXIOM Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of biophysiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. AXIOM Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG). With the AXIOM Sensis system the user can perform a number of calculations based on the input signals and other hemodynamic parameter values entered by the user.

This 510(k) summary describes a diagnostic and administrative tool for hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The submission focuses on substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment cannot be fully populated from the provided text.

Here is the information that can be extracted or inferred:

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

The provided document does not explicitly state acceptance criteria or present a performance table as would be typical for a new standalone device. Instead, the focus is entirely on demonstrating substantial equivalence to existing legally marketed predicate devices. The implied "acceptance criterion" is that the device's technological characteristics, intended use, and safety/effectiveness are comparable to the identified predicate devices.

The "reported device performance" is essentially the statement of substantial equivalence itself, based on:

• Technological Characteristics: "AXIOM Sensis goes one-step beyond the currently available systems to create modular units with component commonality, streamlined user interface and use, and performance and reliability improvement." This is a general claim, not specific performance metrics.
• Communication Interfaces: Support for DICOM, HL7, Siemens HICOR, Siemens AXIOM Artis, and communication with specific ablation devices (Medtronic Model 4803 Atake® II RF Power Generator, Boston Scientific EP Technologies EPT-100 TC, and Stockert EP-Shuttle ablation devices).
• Platform: Based on the Syngo platform, which itself received 510(k) clearance (K010938).
• Safety/Effectiveness: Reliance on "recognized and established industry practice" and "all equipment is subject to final performance testing," with instructions for use to allow trained healthcare professionals to operate it safely and efficaciously.

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

Not applicable. The submission describes a device based on substantial equivalence and does not detail a study involving a test set of data or human performance evaluation. There is no mention of data provenance.

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. As no test set for clinical performance evaluation is described, there's no mention of experts establishing ground truth.

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

Not applicable. No test set requiring adjudication is described.

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 applicable. The device is a diagnostic and administrative tool for hemodynamic and electrophysiology studies, not an AI-assisted diagnostic tool for interpretation by human readers. No MRMC study is described.

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

This refers to a standalone performance study. The document confirms that "all equipment is subject to final performance testing." However, specific details about such testing (e.g., protocols, acceptance criteria, results for individual measurements) are not provided in this 510(k) summary. The submission relies on the substantial equivalence to predicate devices, which generally means that if the core functionalities and measurements are within acceptable ranges (implicitly, similar to the predicates), then it is deemed safe and effective.

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

Not applicable in the context of a clinical performance study. For the measurements the device performs (e.g., invasive blood pressure, ECG signals, intracardiac electrograms), the "ground truth" would be established by the physical sensing and measurement principles, calibrated against known standards, similar to the predicate devices.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI that would require a "training set" in the conventional sense.

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

Not applicable, as no training set is described.

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