(157 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 user-defined 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 provided text describes a 510(k) premarket notification for the RHYTHMIA HDx™ Mapping System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving that the device meets specific acceptance criteria through a rigorous clinical study involving AI algorithms and human reader performance metrics.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., MRMC study, effect size of AI assistance, expert consensus ground truth, training set details) are not applicable or not explicitly detailed in this type of regulatory submission. This submission primarily focuses on engineering verified performance through bench testing, animal studies, and software verification/validation, rather than clinical performance metrics in humans.
Here's a breakdown based on the provided text, addressing what is available and indicating what is not:
Device Name: RHYTHMIA HDx™ Mapping System
Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer
Product Code: DQK
Regulatory Class: Class II
1. Acceptance Criteria and Reported Device Performance
The text does not present a formal table of "acceptance criteria" with specific quantitative metrics (e.g., sensitivity, specificity, accuracy targets) for clinical performance in humans, nor does it report these performance metrics. Instead, it describes various types of testing and their successful completion, aimed at demonstrating substantial equivalence and device functionality.
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Biocompatibility | "Passed all tests in accordance with appropriate test criteria and standards." (for accessories with limited skin contact, using same materials/processes as predicate system) |
| Electrical Safety & EMC | "Demonstrat[ed] compliance to the following standards: IEC 60601-1 +A1; IEC 60601-2-27; IEC 60601-1-2; and IEC 60601-1-6." |
| Software Verification & Validation | "Conducted in accordance with FDA Guidance... The software for this device was considered a 'major' level of concern because the software provides diagnostic information that directly drives a decision regarding treatment or therapy that could lead to serious injury." (Implies successful V&V for this classification). |
| Bench Performance - Mapping & Visualization | "Confirmed that the subject mapping system may be used to accurately create 3D maps of the cardiac chambers of the heart as well as support visualization of magnetic and impedance tracked BSC and 3rd party catheters." |
| Bench Performance - Hardware Performance | "Confirmed that: (1) the subject system devices and accessories meet the functional requirements; and (2) the accessories can be connected to the Signal Station as intended according to their intended use." |
| Bench Performance - System Level Performance | "Confirmed system level functionality under expected and worst case use conditions." |
| Animal Study - Clinical Acceptability | "Demonstrate that the subject mapping system: (1) conforms to the intended customer requirements; and (2) is clinically acceptable in comparison to the predicate CARTO® 3 EP Navigation System." |
| Animal Study - Safety | "No procedure related complications or premature deaths occurred due to the use of the subject mapping system." |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any human performance test, as such a test is not described. For the animal study, it refers to "a canine model" but a specific number of animals is not provided.
- Data Provenance: Not applicable for human clinical data, as it's not a clinical performance study. The animal study involved a "canine model," implying lab animals, but the country of origin is not specified. The studies were likely internal to Boston Scientific or conducted by a contracted research organization.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided as the submission does not detail a study involving human experts establishing ground truth for a diagnostic AI algorithm. The device is a "mapping system" and "programmable diagnostic computer," implying it provides data for medical professionals to interpret, rather than itself making a diagnosis that requires expert-established ground truth validation.
4. Adjudication Method for Test Set
- Not applicable as there is no mention of a human-read test set or ground truth establishment process that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence based on technological characteristics, bench performance, and animal study observations, not a human reader study comparing AI-assisted vs. unassisted performance.
- Effect Size of Human Readers Improvement: Not measurable or reported as an MRMC study was not conducted.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- The text describes the "RHYTHMIA HDx™ Mapping System" as a device for "catheter-based atrial and ventricular mapping" that allows "real-time visualization... and display of cardiac maps" and "acquired patient signals... may also be recorded and displayed." This implies it provides raw data and processed maps for a human clinician to interpret rather than an autonomous diagnostic outcome that would have a "standalone performance" metric. Therefore, the concept of a standalone AI performance study as typically understood for diagnostic AI is not directly applicable or reported here. Its "performance" is described in terms of its ability to accurately create and display maps and signals.
7. Type of Ground Truth Used
- For the bench testing, the "ground truth" would be engineering specifications and known physical properties, confirmed by validation against established standards.
- For the animal study, "clinical acceptability" was compared to a predicate device. This implies the existing understanding of what constitutes a correct and useful cardiac map in a preclinical setting, likely evaluated by veterinary cardiologists or equivalent experts in electrophysiology. It's not a "pathology" or "outcomes data" ground truth in the sense of confirming a disease state.
8. Sample Size for Training Set
- Not applicable. This submission doesn't describe the development of an AI/ML algorithm requiring a training set in the modern sense. The "software" mentioned is for functionality and processing, not for learning from data to perform diagnostic interpretation.
9. How Ground Truth for Training Set Was Established
- Not applicable. See point 8.
§ 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).