(36 days)
The Sensis recording system is intended to be used 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 device is intended to be used on either or both of the following populations:
- Adult and pediatric populations requiring intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
- Adult and pediatric populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is a further SW and HW development of the commercially available Siemens AXIOM Sensis K020440.
The Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG) The user can perform a number of calculations based on manual input and / or on the input signals and other hemodynamic parameter values from the Sensis system.
For more flexibility in the department, additional post processing and reporting workplaces can always be connected to the network.
The software and hardware modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
This 510(k) summary for the Siemens Sensis device is primarily a substantial equivalence claim based on modifications to an existing predicate device (AXIOM Sensis K020440). As such, it does not detail a traditional "study" with new performance metrics or acceptance criteria for the modified device in the same way a de novo device might. Instead, it relies on reaffirming the performance of the predicate and demonstrating that the changes do not negatively impact safety or effectiveness.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Software Functionality | Conformance to software specifications. No identified hazards. | All software specifications have met the acceptance criteria. Risk control implemented to mitigate identified hazards. Testing for verification and validation found acceptable. |
| Electrical Safety | Conformance to IEC Standards. | EMC/electrical safety evaluated according to IEC Standards. Conformance to Voluntary Standards covering Electrical and Mechanical Safety certified. Identified risk of electrical hazards mitigated. |
| Mechanical Safety | Conformance to Voluntary Standards. | Conformance to Voluntary Standards covering Electrical and Mechanical Safety certified. |
| Biocompatibility | OEM manufacturer ensures biocompatibility for patient-contacting sensors. | Sensors applied to patients are provided by OEM with their own 510(k) clearances, ensuring biocompatibility and sterilization (where applicable). Sensis components do not directly contact patients. |
| Safety and Effectiveness | Substantial equivalence to predicate (AXIOM Sensis K020440) in terms of safety and effectiveness, despite SW/HW development. | The identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation have been completed. The Sensis VC12 is substantially equivalent to the AXIOM Sensis (K020440). |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify a sample size for a clinical test set.
- Data Provenance: The performance testing mentioned is "Non clinical tests (integration and functional) conducted on the Sensis software during product development." This implies retrospective data generated internally during development and verification/validation processes. There is no mention of patient data, country of origin, or prospective studies for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided. As the testing was "non-clinical" and focused on software and system functionality, the concept of "ground truth" derived from expert clinical opinion in the traditional sense for diagnostic accuracy studies does not apply here. The "ground truth" for software testing would be the expected output or behavior defined by design specifications.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers resolve discrepancies in diagnostic interpretations. Given the non-clinical nature of the testing described, this would not be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- An MRMC comparative effectiveness study was not performed, and is not applicable. The Sensis device is described as a "diagnostic and administrative tool" for recording and monitoring bio-physiological events, not an AI-powered diagnostic aid that improves human reader performance in interpreting images or complex data. The document explicitly states: "Clinical testing was not applicable as Sensis has no new indications for use nor new clinical applications were introduced to the system."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device Sensis is not described as an "algorithm only" device. It is a "multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events." Therefore, the concept of "standalone (algorithm only)" performance as it relates to AI is not applicable. The device's performance is tied to its function as a recording and display system, which inherently involves human interaction for interpretation and use. The non-clinical tests would have evaluated the system's ability to accurately measure, display, and process signals as designed.
7. The Type of Ground Truth Used
- For the non-clinical software and integration tests, the ground truth would have been based on predefined design specifications and expected system behavior. For example, a "ground truth" for a signal measurement might be a known electrical input signal, and the system's output is compared against that. For functional tests, the ground truth would be the correct execution of a function according to its requirements. There is no mention of expert consensus, pathology, or outcomes data as ground truth for this device's validation.
8. The Sample Size for the Training Set
- Not applicable/Not provided. The Sensis system is not described as an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on established engineering principles for signal acquisition, processing, and display, rather than learned patterns from a large dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided. As there is no mention of a training set, the establishment of its ground truth is not relevant here.
In summary: The submission for the Sensis device is a "Special 510(k)" which focuses on demonstrating substantial equivalence through non-clinical testing of software and hardware modifications. It explicitly states that clinical testing was not applicable because there were no new indications for use or clinical applications introduced. The "acceptance criteria" and "study" largely revolve around internal verification and validation against engineering specifications and industry standards to ensure the modified device remains safe and effective, and substantially equivalent to its predicate.
§ 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).