(130 days)
Affera Integrated Mapping System: The Affera Integrated Mapping System is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
Impedance Localization Patch Kit: Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.
Affera Integrated Mapping System: The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive electromagnetic sensors embedded in the catheter. In addition to magneticbased tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors.
The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU.
The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.
Impedance Localization Patch Kit: The Impedance Localization Patch Kit is an accessory device used with the Affera Integrated Mapping System that includes 6 surface localization patches. Patches are placed in fixed positions in contact with the patient's skin to deliver low energy patient auxiliary signals to enable the integrated mapping system to allow visualization of catheters that do not contain electromagnetic location sensors, and to support detection of respiratory motion and to provide information regarding patient position and movement.
The provided text is a 510(k) summary for the Affera Integrated Mapping System and Impedance Localization Patch Kit. Unfortunately, this document does not contain the detailed acceptance criteria and performance study results in the format requested.
Here's an analysis of what is available and what is missing:
What is present in the document:
- Device Name: Affera Integrated Mapping System; Impedance Localization Patch Kit
- Intended Use: Catheter-based electrophysiological mapping and stimulation.
- Indications for Use: Detailed for both the mapping system and the patch kit.
- Predicate Devices:
- Technological Characteristics Comparison: Provides a high-level comparison of the subject device with its predicate devices, highlighting similarities and differences in intended use, technology (magnetic vs. hybrid electromagnetic-impedance tracking), key components, mapping capabilities, stimulation, and ECG/EGM acquisition.
- Safety and Performance Data Overview: States that "Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements, including specifications and requirements related to use with compatible catheters and ablation systems." It lists categories of testing performed:
- Design verification testing
- Design validation
- Summative usability evaluation
- Pre-clinical animal testing
- Electrical safety and EMC testing
- Biocompatibility testing (AFR-00015)
- Packaging validation
- Software validation and cybersecurity testing
- Conclusion: The device is considered substantially equivalent to the predicate devices, and "all acceptance criteria were met in accordance with appropriate standards."
What is missing from the document (and therefore cannot be provided in the table/answers):
- A table of acceptance criteria and the reported device performance: The document explicitly states "all acceptance criteria were met," but it does not provide a table detailing those criteria or the quantitative results of the device's performance against them. For example, it doesn't specify what constitutes "met" for design verification or what the specific performance metrics (e.g., accuracy, precision, latency) were for localization or mapping.
- Sample size used for the test set and the data provenance: There is no mention of the specific sample sizes for any performance tests, nor their origin (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: The document does not mention an MRMC study or any quantitative improvement metrics for human readers with AI assistance. The device is a "mapping system" and "patch kit," not primarily an AI algorithm for reader interpretation.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: While it's a mapping system with embedded software, the document doesn't explicitly describe standalone algorithm performance studies in the way requested for AI/diagnostic devices. The description focuses on its function with human interaction (e.g., displaying information to the user).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not specified for any of the mentioned testing.
- The sample size for the training set: There is no mention of a "training set" or its size, as this document focuses on the performance testing for regulatory clearance, not the development process of an AI/ML model for which a training set would be typical.
- How the ground truth for the training set was established: Not applicable, as no training set is mentioned.
In summary, while the document confirms that performance testing was conducted and acceptance criteria were met, it does not provide the granular details required to complete your request. It primarily serves as a regulatory summary for substantial equivalence, not a detailed technical report of performance metrics.
§ 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).