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The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

The RhythmView Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Solid State Hard Drive (optional component), Keyboard, Mouse, Two Port USB Switch, Video Splitter (new component - streaming option only), *Panel box required, Software. RhythmView takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The Rhythm View computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.

The provided text describes the RhythmView Workstation SW V5.0, a computerized system that assists in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document for the RhythmView Workstation SW V5.0 (K151245) indicates that the device's performance was evaluated through verification and validation testing, including Electrical Safety and EMC testing, and usability testing. The document states that these tests provide "reasonable assurance that the proposed device conformances to the appropriate requirements for its intended use" and that "it has been demonstrated that the RhythmView Workstation is safe and effective for its intended use."

However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and their corresponding reported performance values are not explicitly detailed in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards rather than quantitative clinical performance metrics.

The "Device Characteristic" table in Appendix 1: 510(k) Summary compares the proposed and predicate RhythmView Workstations in terms of features and functionality. This table can be interpreted as a set of functional requirements or acceptance criteria for the new version, demonstrating that it either maintains existing functionality ("Yes" in both columns) or introduces new features ("Yes" in Proposed, "No" in Predicate).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies mentioned. The testing described is primarily focused on software and hardware verification/validation, and usability, rather than a clinical performance study with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the text. Given that the testing mentioned is primarily verification, validation, and usability, it's unlikely that a traditional "ground truth" for clinical performance, as established by multiple clinical experts, was a primary component of this regulatory submission.

4. Adjudication Method for the Test Set

This information is not provided in the text.

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 is not mentioned in the provided text. The device is described as "assisting" in diagnosis and displaying information for a physician's review, but there is no data presented on human reader performance improvement with or without the AI.

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

A standalone performance study of the algorithm is not explicitly mentioned in the provided text in terms of quantitative clinical metrics (e.g., sensitivity, specificity). The focus is on the workstation as a whole and its functionality in assisting a physician. The statement "The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder" confirms the presence of an algorithm, but its standalone performance is not quantified.

7. The Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for any clinical performance evaluation. The "ground truth" for the verification and validation (V&V) testing would likely refer to engineering specifications and expected software behavior, and for usability testing, it would relate to user task completion and satisfaction. For the underlying algorithms that "compute spatial organization," the ground truth, if evaluated, would typically be established based on accepted electrophysiological principles or expert consensus in the field.

8. The Sample Size for the Training Set

The text does not provide any information regarding a training set sample size. This type of detail is typically associated with the development of the "proprietary patented algorithms and methods" but is not part of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

The text does not provide any information regarding how the ground truth for a training set was established.

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The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

The RhythmView™ Workstation is comprised of the following components: Cart, Keyboard, Monitor/Display, Mouse, Computer Software, Radio-Frequency Identification (RFID) Reader/Writer (new component), Two Port USB Switch (new component), Solid State Hard Drive (new optional component). RhythmView™ takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView™ computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView™ then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table detailing device performance against such criteria. The closest information is a general statement about testing:

2. Sample Size for Test Set and Data Provenance

The document does not specify a sample size for any test set or the provenance (country of origin, retrospective/prospective) of the data used in testing. It only mentions "User testing" in a general sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for a test set, nor does it provide qualifications for any such experts. The device is described as assisting physicians in diagnosis, implying that the physician ultimately establishes the diagnosis.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. It focuses on the device assisting physicians rather than comparing physician performance with and without the device.

6. Standalone (Algorithm Only) Performance Study

The document implies a standalone function as the device "computes and displays electrical rotors or focal beat sources" using algorithms, but there is no explicit separate study reporting standalone algorithm-only performance. The "User testing" mentioned likely involves human interaction with the device.

7. Type of Ground Truth Used

The document does not explicitly define the type of ground truth used for any testing. Given the device's function to "assist in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals," it is implied that the ultimate ground truth would be a clinical diagnosis established by a physician based on all available clinical information, potentially including the device's output.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information regarding how ground truth for a training set was established.

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The Topera FIRMap™ Mapping Adapter Connector (MAC) is indicated for use with Topera's FIRMap™ Catheters in cardiac electrophysiology procedures. Refer to the individual Instructions for Use of the associated FIRMap Catheter. It is important to carefully review the specific indications included with the associated catheters prior to use.

The FIRMapTM MAC is a re-usable, non-sterile, non-patient contact device that is intended to be used in conjunction with the FIRMapTM catheter. The MAC acts as an interface between the catheter and electrophysiology recording system by connecting the extension cable to the EP system fan out cable.

This document describes the regulatory submission for the FIRMap Mapping Adapter Connector (MAC), a reusable, non-sterile device intended to interface Topera's FIRMap™ Catheters with electrophysiology recording systems.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the MAC underwent these tests and, based on the test data, "it has been demonstrated that the MAC is safe and effective for its intended use." This implies that the device met the acceptance criteria for each of these tests, even though specific pass/fail values or detailed results are not provided.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the performance tests (Electromagnetic Compatibility, Continuity and Hi Pot, Mate Demate Cycle, Mate Demate Force).

The data provenance is not specified. It is likely internal testing performed by Topera, Inc. as part of their device development and regulatory submission process. There is no indication of country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. The FIRMap MAC is a hardware connector, and its performance tests (EMC, continuity, mechanical durability) are typically evaluated against engineering standards and specifications, not against "ground truth" established by clinical experts in the same way a diagnostic algorithm would be.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the type of engineering performance testing conducted for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for evaluating results against human interpretations.

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, an MRMC comparative effectiveness study was not done. The device is a hardware connector and not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. The device is a passive hardware component, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as expert consensus, pathology, or outcomes data is not directly applicable to the engineering performance tests (EMC, continuity, mechanical) conducted for this device. The "ground truth" for these tests would be the established engineering specifications and regulatory standards that the device must meet to function safely and effectively. For example, for "Continuity and Hi Pot," the ground truth would be a pass/fail according to a predefined electrical resistance or dielectric strength threshold.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The FIRMap MAC is a hardware device developed through engineering design and testing, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. As mentioned above, there is no "training set" for this hardware device.

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The Rhythm View™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™ Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

The RhythmView™ Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Keyboard, Mouse, Software. RhythmView™ takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView™ computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The Rhythm View™ then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.

Here's an analysis of the provided text regarding the Rhythm View™ Workstation 4.1, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) for the Rhythm View™ Workstation 4.1. The performance data section broadly states:

It appears that the approval was based on the software testing demonstrating conformance to its intended use and a finding of substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics. The focus is on the functional equivalence of the new display option ("Rotational Activity Profile") to existing functionalities.

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It only mentions "software testing" in a general sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The provided text does not mention any experts being used to establish ground truth for a test set, nor does it describe their qualifications.

4. Adjudication Method for the Test Set

The provided text does not describe an adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or discuss any effect size of human readers improving with or without AI assistance. The submission is for a workstation that assists in diagnosis, not explicitly an AI-driven diagnostic tool in the modern sense as described here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The provided text does not specify if a standalone performance study was done. The device is described as assisting in diagnosis and displaying information for physician review, implying a human-in-the-loop system.

7. The Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used for any performance evaluation. Given the nature of the device (analyzing electrical signals to display spatial organization for rhythm disorders), ground truth would likely involve confirmed clinical diagnoses or expert consensus on arrhythmia classification, but this is not detailed.

8. The Sample Size for the Training Set

The provided text does not specify any sample size for a training set. The document primarily focuses on a 510(k) submission for a new version (4.1) of an existing device, which introduces an additional display option. It's less about a new algorithm with a distinct training phase.

9. How the Ground Truth for the Training Set Was Established

The provided text does not provide information on how ground truth was established for any training set.

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For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Topera FIRMap™ Catheter may also be used for delivery of externally generated pacing stimuli.

The FIRMap™ Catheter is comprised of these major components,
• Handle
• Handle Strain Relief
• Introducer Tool
• Catheter Shaft
• Basket

The FIRMap™ Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The distal, expandable basket assembly is, in essence, eight miniature octapolar catheters that are arranged into a three dimensional "basket" shape.. The basket assembly contains an array of 64 electrodes mounted onto eight support structures called splines.

The provided text describes the regulatory clearance of the FIRMap™ Catheter, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way envisioned by the posed questions (e.g., regarding performance metrics like accuracy, sensitivity, or specificity for a diagnostic device).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "Performance data" section only states that various tests (biocompatibility, dimensional, mechanical integrity, mate/de-mate, electrical safety, and GLP animal study) were performed to support substantial equivalence. It does not provide specific acceptance criteria or the results of these tests in a quantifiable manner relevant to clinical performance.

Therefore, I cannot populate most of the requested table or answer the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies from the provided text.

Here's what I can extract based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance

Explanation of Gaps: The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and safety testing (biocompatibility, mechanical, electrical). It does not detail specific acceptance criteria for diagnostic capability (e.g., accuracy in identifying arrhythmias) or present data from a study that quantifies the device's performance against such criteria.

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not provided. The document mentions "GLP animal study" but gives no details about sample size, design, or data provenance. There is no mention of human clinical trial data for performance evaluation in this 510(k) summary.

2. 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)

   • Not provided. Since no specific clinical performance study is detailed, there's no mention of experts establishing ground truth for a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not provided.

4. 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 such study is mentioned. The device is a catheter for recording electrical potentials and delivering pacing stimuli, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable/Not provided. The FIRMap™ Catheter is a medical device (electrode recording catheter), not an algorithm or standalone AI system. Its performance would be evaluated in terms of its ability to accurately record electrical signals, not as an "algorithm only" system.

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

   • Not provided. As no specific performance study against a clinical ground truth is detailed, this information is absent. The "GLP animal study" would likely involve physiological measurements as ground truth, but specific details are missing.

7. The sample size for the training set

   • Not applicable/Not provided. The FIRMap™ Catheter is a hardware device; it does not explicitly use a "training set" in the context of machine learning.

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

   • Not applicable/Not provided.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through comparison of technological characteristics and general safety/performance testing (biocompatibility, mechanical, electrical). It does not contain the detailed clinical performance study data, acceptance criteria, or ground truth methodologies that would be typical for evaluating a diagnostic algorithm's accuracy, sensitivity, or specificity.

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The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

The RhythmView is comprised of these major components,

1. RhythmView hardware - Cart, Computer, monitor, keyboard, and mouse
2. RhythmView software - Software pre-installed
   The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.

The provided text does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria. It states that "Based upon the RhythmView 4.0 Software V&V Testing and the documentation required to support a Moderate Level of Concern Software Device (per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices), it has been demonstrated that the RhythmView is safe and effective for its intended use." However, it does not provide the specifics of this V&V testing, acceptance criteria, or the reported performance.

Therefore, I cannot provide the requested table and study details. The document is a 510(k) summary and the FDA's clearance letter, which describe the device, its intended use, and the regulatory decision, but do not elaborate on the specific performance study results.

Ask a specific question about this device

The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

The RhythmView is comprised of these major components,

1. RhythmView hardware – Computer, monitor, keyboard, and mouse
2. RhythmView Software – Software pre-installed

The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.

Here's an analysis of the provided text regarding the acceptance criteria and study for the RhythmView Workstation:

The provided document does not contain explicit stated acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative thresholds for signal processing or display characteristics). Instead, it states that the system "passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria." It primarily demonstrates substantial equivalence to predicate devices based on technological characteristics and overall safety and effectiveness.

Therefore, the following table and subsequent sections will reflect the information available in the document, highlighting what is stated and what is not.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical performance metrics (e.g., accuracy, precision) for the device's diagnostic assistance capabilities. The "acceptance criteria" are broadly defined as passing verification and validation tests and demonstrating equivalence to predicate devices in safety and effectiveness.

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

• Sample Size for Test Set: The document states that the RhythmView System underwent "extensive bench testing, including a data wide variety of cardiac electrogram data." However, no specific numerical sample size (number of cases or electrogram recordings) for the test set is provided.
• Data Provenance: The document mentions "a data wide variety of cardiac electrogram data." The country of origin for this data is not specified. The document does not explicitly state whether the data was retrospective or prospective. Given the context of "bench testing" and "variety of cardiac electrogram data," it implies existing data sources were used.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document does not mention the involvement of experts in establishing ground truth for the test data.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The document does not describe any adjudication process for interpreting the test data or establishing 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

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done (or at least not reported in this summary). The document focuses on the device's performance in isolation ("bench testing") and its substantial equivalence to predicate devices based on technological characteristics and overall safety/effectiveness, not on human reader performance with or without the device.
• Effect Size of Improvement: Not applicable, as no such study was reported.

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

• Standalone Performance Study: Yes, in essence, the "extensive bench testing" of the RhythmView System, where it "passed all verification and validation tests," represents a standalone evaluation of the algorithm and system's performance. The device is described as "assists in the diagnosis," implying it's a tool, but the testing described focuses on the system itself, not its impact on a human reader's performance.

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

• Type of Ground Truth: The document refers to "cardiac electrogram data" and the device assisting in the "diagnosis of complex cardiac arrhythmias." This implies that the ground truth for the test data would be the actual presence or absence, and specific type, of cardiac arrhythmias as determined by established clinical or electrophysiological standards, which often involves expert interpretation of electrograms and clinical correlation. However, the specific method (e.g., expert consensus, comparison to gold standard recordings) for establishing this ground truth is not explicitly stated.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document does not partition data into training and test sets or mention details about a training set. This suggests that the device's development and validation might have relied on a traditional engineering V&V process rather than a machine learning model requiring a distinct training set in the current common understanding.

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

• How Ground Truth for Training Set was Established: Not specified. As the document doesn't explicitly mention a training set, details on its ground truth establishment are also absent.

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