(82 days)
The RHYTHMIA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
The RHYTHMIA HDx™ Mapping System is a catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time. The mapping system is intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data. In addition, based on userdefined criteria, the system is able to acquire data over multiple cardiac beats. It is capable of real-time display through construction of maps using catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms.
The Signal Station and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system Workstation computer and software.
The subject device is reusable capital equipment that is intended to be used in an electrophysiology laboratory by physicians fully trained in cardiac electrophysiology.
The provided text describes the RHYTHMIA HDx™ Mapping System and its 510(k) submission (K192438). However, it does not contain specific acceptance criteria, detailed results from a study proving it meets those criteria, or the methodology for ground truth establishment and sample sizes for training/test sets.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design features, performance testing, and indications for use. It mentions software enhancements but does not provide quantitative performance metrics against specific acceptance criteria.
Therefore, many of your requested details cannot be extracted directly from this document.
Here's a breakdown of what can be inferred or reported from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance (General) | Implied: The RHYTHMIA HDx™ Mapping System with Software Version 4.0 should perform as intended and meet functional requirements. | "The RHYTHMIA HDx™ Mapping System with Software Version 4.0 passed all tests in accordance with appropriate test acceptance criteria and standards." |
| "The software hazard analysis, verification and performance testing demonstrated that the RHYTHMIA HDx™ Mapping System with Software Version 4.0 performs as intended." | ||
| "Confirmed that the new software features meet the functional requirements." | ||
| Mapping and Visualization (New Features) | Implied: Incorporation of new software features (AutoTag, Stability Filtering) should not negatively impact the ability to accurately create 3D maps or support catheter visualization. | "Confirmed that incorporation of the new software features does not negatively impact the ability to use the subject mapping system to: (1) accurately create 3D maps of the cardiac chambers of the heart; and (2) support visualization of magnetic and impedance tracked catheters." |
| Safety | Implied: No new questions of safety and effectiveness should be raised by the software v4.0 features. | "As a result of hazard analysis of SW v4.0 features, no new questions of safety and effectiveness were raised." |
| Usability | Implied: System-level functionality under expected use conditions should be confirmed. | "Summative Usability - Confirmed system level functionality under expected use conditions." |
Missing from the document: Specific numerical thresholds or definitions for "accurately create 3D maps," or detailed performance metrics like accuracy, precision, sensitivity, specificity, etc., for the mapping system or its new features.
2. Sample size used for the test set and the data provenance
Missing. The document mentions "Performance Testing" but does not provide any details on the sample size (number of patients, cases, or data points) used for these tests. It also does not specify the provenance of any data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing. The document does not describe the establishment of a "ground truth" using human experts for the performance tests. The testing appears to be functional and safety-focused against internal standards, rather than comparative evaluation against expert-labeled ground truth data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Missing. Given the nature of the described testing (functional verification, not a clinical study comparing to ground truth), an adjudication method for a test set is not mentioned, nor would it typically apply in this context based on the information provided.
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
No. The document does not indicate that an MRMC comparative effectiveness study was performed. The RHYTHMIA HDx™ Mapping System is a diagnostic and mapping system, and the new features (AutoTag and Stability Filtering) are described as workflow enhancements rather than AI-driven diagnostic assistance for human readers in the traditional sense that would require an MRMC study to measure reader improvement. The focus appears to be on the system's own performance and functionality.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The performance testing described ("Mapping and Visualization," "Software Performance") seems to refer to the standalone performance of the system's software and hardware components. For instance, testing if the system can "accurately create 3D maps" implies evaluating the algorithm's output without direct human intervention impacting the mapping process itself, although a human would
interpret the resulting map. However, specific metrics for "standalone performance" are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing. The document does not specify the type of "ground truth" used for assessing the accuracy of 3D maps or other functional aspects. It refers to compliance with "appropriate test acceptance criteria and standards," suggesting validation against predefined functional specifications rather than a clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
The document describes software enhancements (AutoTag, Stability Filtering) but does not provide any information about an AI model that would require a "training set." It doesn't mention machine learning or deep learning being used as part of these new features in a way that would necessitate a distinct training dataset. If these features utilize algorithms, they are likely rule-based or conventional signal processing, not requiring "training data" in the AI sense.
9. How the ground truth for the training set was established
Not Applicable (based on available information). As no training set is mentioned or implied for AI model development, the method of establishing its ground truth is not discussed.
§ 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).