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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 diagnostic medical device designed for 3D cardiac mapping, catheter navigation and display of cardiac electrophysiological data collected during an Electrophysiology (EP) study. Based on user-defined criteria, the Mapping System can acquire data over multiple cardiac beats.

The maps are constructed using magnetic and impedance-based localization technology and data from intracardiac and surface electrograms. Maps may be displayed as anatomical maps and electroanatomical maps in different formats. When used in conjunction with a magnetically tracked mapping catheter, the Mapping System can acquire data leading to high resolution map creation. The Mapping System allows real-time and recorded visualization of intracardiac catheter location(s). The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

The Mapping System consists of reusable capital equipment, intended to be used in an electrophysiology laboratory by licensed medical practitioners fully trained in cardiac electrophysiology and Boston Scientific Mapping Specialists.

The Mapping System includes a dedicated Signal Station (SiS) and related accessories which provide data connection pathways for external input/output devices (e.g., catheters and recording systems) and serve as the data conduit to the System's Workstation computer and software.

The provided text describes the RHYTHMIA HDx™ Mapping System and its updates, but it does not contain the detailed acceptance criteria and a specific study proving the device meets those criteria, as requested. The "Performance Data" section lists general types of testing performed (Software/Firmware and Cybersecurity Verification and Validation, Design Verification, EMC and Electrical Safety, Usability Validation, and Design Validation) and states that successful results were achieved, but it lacks the quantitative details, methodology, and specific results required to answer your questions.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, and training set details.

The text does provide information regarding:

• Device Name: RHYTHMIA HDx™ Mapping System
• Intended Use: Catheter-based atrial and ventricular mapping. Allows real-time visualization of intracardiac catheters, display of cardiac maps, and recording/display of patient signals (body surface ECG and intracardiac electrograms).
• Technological Characteristics (Enhancements in v6.0):
  • Compatibility with Magnetically Tracked FARAWAVE NAV PFA Catheter.
  • Improved compatibility with Magnetically Tracked FARAPOINT PFA Catheter.
  • Sheath detection visualization.
  • Import of CT or MRI cardiac images from PACS Server (for visual reference only).
  • Field Tag™ (tagging visualization when using FARAWAVE NAV PFA catheter).
  • Catheter shadows (visualize last ablation location).
  • Ablation statistics.

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The RHYTHMIA HDx™ Mapping System (with software Version 2.0) 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 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 FDA 510(k) summary for the RHYTHMIA HDx™ Mapping System (with software Version 2.0) describes the device and its performance testing. However, it does not include detailed acceptance criteria in a quantitative table format nor does it directly present a "study that proves the device meets the acceptance criteria" in the way one might expect for a robust AI/ML performance evaluation. The document focuses on showing substantial equivalence to a predicate device and software validation.

Here's a breakdown of the requested information based on the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject RHYTHMIA HDx Mapping System software Version 2.0 passed all tests in accordance with appropriate test acceptance criteria and standards." however, it does not provide a specific table of acceptance criteria or quantitative performance metrics.

The testing described is functional and safety-oriented, rather than a performance study with specific metrics like sensitivity, specificity, or accuracy.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated in terms of patient data or cases. The "bench performance testing" implies internal testing, but the size of data sets (e.g., number of mapping runs, number of anatomical models) is not provided. The animal study involved an unspecified number of animals to demonstrate safety, not a test set for performance metrics.
• Data Provenance: Not explicitly stated. The animal study is a pre-clinical study. For the bench testing, the origin of data is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the document does not describe a performance study involving expert-established ground truth for a test set. The evaluation is focused on functional verification and validation, as well as safety.

4. Adjudication method for the test set

This information is not provided as the document does not describe a performance study involving expert-established ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device is a mapping system, not specifically an AI diagnostic tool designed to augment human reader performance in a comparative study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The RHYTHMIA HDx™ Mapping System is described as a "catheter-based atrial and ventricular mapping system" that provides "real-time visualization" and "display of cardiac maps." While it uses advanced software, it is not presented as a standalone AI algorithm (without human-in-the-loop performance) in the context of this document. Its function is to assist physicians during electrophysiology procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional testing, the "ground truth" would likely be based on established engineering specifications and validated simulation models or physical phantoms. For the animal study, the ground truth for safety would be physiological measurements and observation of the animals. No mention of expert consensus, pathology, or outcomes data as ground truth for a performance study.

8. The sample size for the training set

This information is not applicable/provided. The document describes a software update for a medical device mapping system. It does not indicate that the system employs machine learning or a neural network that would require a "training set" in the conventional sense for AI/ML development. The software enhancements are described as "DirectSense™ feature provides real-time display of local impedance," "Enhanced CT and MRI capabilities," "Improved initial map setup," and "Support for multiple monitor displays," along with "Minor bug fixes." These are features unlikely to involve a separate training set.

9. How the ground truth for the training set was established

This information is not applicable/provided as there is no mention of an AI/ML training set.

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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.

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.

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