(125 days)
The Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical 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 data using the administrative tools.
The device is intended to be used on either or both of the following populations:
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Adult and pediatic populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
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Adult and pediations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.
Sensis is a multi-channel computer-based stationary system for the display, and printout of bio-physiological measurement. 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.
The Sensis System can be used also for vascular procedures in interventional radiology and surgery the same way as for cardiac procedures in interventional cardiology. The Sensis functionality remains the same.
For more flexibility in the department, additional post processing and reporting workplaces can always be connected to the network.
A Drug Med Calculator has been added to the Sensis. It uses established formulas which could also be used in Siemens secondary predicate the Cathcor system. The Drug Med Calculator provides a workflow improvement for the users and allows ease calculations for the drug amount dosage and creatinine clearance.
The provided document is a 510(k) summary for the Siemens Sensis Electrophysiological and Hemodynamic Recording System (K150493). This submission describes modifications to a previously cleared device (K131812), primarily updating the indications for use and adding a Drug Med Calculator.
Based on the provided text, the device is considered substantially equivalent to a predicate device, and the evaluation relies heavily on non-clinical testing and verification/validation of software and adherence to recognized standards. Therefore, the information regarding specific acceptance criteria and detailed study results might not be as explicit as a clinical trial report for an AI algorithm.
Here's an attempt to answer your questions based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics for an AI algorithm. Instead, the acceptance criteria are framed in terms of conformance to safety and performance standards for a medical device with software, and the performance refers to the functionality and safety of the updated Sensis system.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Software Functionality | All software specifications met. |
| Continuous conformance with special controls for medical devices containing software. | |
| Safety - Electrical | Complies with IEC 60601-1, IEC 60601-2-25, IEC 80601-2-30, IEC 60601-2-34, IEC 80601--61. All tests passed. |
| Safety - EMC (Electromagnetic Compatibility) | Complies with IEC 60601-1-2. All tests passed. |
| Risk Management | Risk analysis completed; risk controls implemented to mitigate identified hazards. |
| Usability (Human Factors) | Complies with IEC 62366 and IEC 60601-1-6. |
| Quality Management System | Conforms to ISO 14971 (Risk Management). |
| Cybersecurity | Implements a process of preventing unauthorized access, modifications, misuse, or denial of use. Conforms to IEC 80001-1:2010. |
| Drug Med Calculator Accuracy | Uses established formulas (same as Siemens Cathcor K002137). |
| Overall Performance | Performance tests showed the functionality of the Sensis Electrophysiological and Hemodynamic Recording System. Results were found acceptable in supporting the claim of substantial equivalence. |
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 provide information on sample sizes for a test set in the context of an AI algorithm or clinical data. The testing mentioned is primarily for device verification and validation (V&V) and conformity to standards rather than a clinical performance study with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable or stated.
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 in the document. The submission focuses on device V&V and safety, not on a clinical performance study involving expert assessment of outputs or ground truth establishment by clinical experts. The device (Sensis) is a recording system, and the updates concern software functionality and expanded indications, not a diagnostic AI that would require expert-established ground truth for its outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the nature of the device and testing described. Adjudication methods are typically used in clinical studies for diagnostic accuracy, which is not the focus of this 510(k) summary.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The Sensis system is described as a "diagnostic and administrative tool," not an AI-powered diagnostic aide designed to improve human reader performance in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a medical device (Sensis recording system) with updated software, not a standalone AI algorithm. The "Drug Med Calculator" is a feature, not a complex AI algorithm, and its performance relies on "established formulas." Therefore, a standalone AI algorithm performance study as typically understood in the context of machine learning was not performed or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Drug Med Calculator," the ground truth implicitly used would be the established formulas themselves, which are stated to be "the same as used with Siemens Cathcor." For the overall Sensis system, the ground truth for its functionality would be its adherence to design specifications and recognized medical device standards during verification and validation testing. There is no mention of ground truth derived from expert consensus, pathology, or outcomes data in the context of a diagnostic performance study for this device.
8. The sample size for the training set
The device described is a recording system with software updates, not a machine learning model that requires a "training set" in the conventional AI sense. Therefore, information on a training set sample size is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no mention of a traditional AI training set, this question is not applicable. The "ground truth" for the device's functionality is its compliance with engineering specifications, industry standards, and the accuracy of its calculations based on established formulas.
§ 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).