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The Volta AF-Xplorer assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The clinical significance of utilizing the Volta AF-Xplorer software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The Volta AF-Xplorer is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms.

The Volta AF-Xplorer device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:

• two compatible EP recording systems (identical to VX1 and VX1+ (Volta Medical (K201298, । K223516)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
• a 3D mapping system (new compared to VX1 and identical to VX1+): EnSite X 3D mapping system -(Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the Volta AF-Xplorer system, depending on the type of communication used:

• -Unidirectional analog communication with the EP recording systems via a custom-made cable (two diferent variants: DSUB, Octopus) and an Advantech PCI-1713U analog-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer software.
• -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20.10. 5 or 2m) which transmits the digital signals directly to the computer.

The computer and its attached display are located outside the sterile operating room area. The Volta AF-Xplorer software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring dispersed electrograms as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

The provided text describes the 510(k) summary for the Volta AF-Xplorer and its substantial equivalence to previous predicate devices (VX1+ and VX1). However, the document does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria in a structured format. Instead, it generally states that "The testing and acceptance criteria are the same as those in the predicate VX1+ and VX1 devices" and that "The processing was evaluated and demonstrated equivalent performance with the acceptance criteria from the VX1+ and VX1 studies."

Therefore, I cannot directly extract the specific information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert details, or ground truth establishment based solely on the provided text. The document indicates that such studies were performed for the predicate devices and that the Volta AF-Xplorer maintained equivalent performance, but the specifics of those studies are not detailed here.

To answer your request, I would need access to the performance data and study reports for the VX1+ and VX1 devices, which are referenced but not included in this 510(k) summary.

Based on the available text, I can only provide the following information from the document:

• Device Performance (General Statement): The Volta AF-Xplorer demonstrated "equivalent performance with the acceptance criteria from the VX1+ and VX1 studies."
• Study Type (Inferred): The document refers to "software design verification" and "bench testing" that was previously conducted for the VX1+ (K201298) to demonstrate "rigorous software verification testing including unitary testing of the main algorithm modules."
• Training Set (Not specified in this document): Information about the training set size or how its ground truth was established is not present in this document.
• Test Set (Not specified in this document): Information about the test set size, data provenance, number/qualifications of experts, or adjudication methods is not present.
• MRMC Study / Standalone Performance: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or provide details on standalone (algorithm-only) performance.
• Ground Truth Type (Not specified in this document): The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not detailed.

In summary, the provided FDA 510(k) letter and summary state that the performance data for Volta AF-Xplorer were deemed sufficient through equivalence to its predicate devices, but it does not detail the underlying studies, acceptance criteria, or performance metrics themselves.

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The VX1+ assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1+ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs).

The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:

• two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
• a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used:

• Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software.
• -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer.

The computer and its attached display are located outside the sterile operating room area. The VX1+ software analyzes the patient's electrograms to cue operators in real-time to intracardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

The provided text describes the acceptance criteria and a study for the Volta Medical VX1+ device. However, it does not contain a detailed table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) and corresponding reported device performance, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.

Based on the available information, here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document describes non-clinical and clinical tests performed, implying certain underlying acceptance criteria were met for substantial equivalence to the predicate device (VX1). However, explicit quantitative acceptance criteria (e.g., "sensitivity > 90%") are not provided in the text. The reported device performance is described generally as "acceptably correlate" and "reliably assists."

Table of Acceptance Criteria and Reported Device Performance (as inferred and with missing specifics):

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The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way typically seen in a formal statistical analysis plan. However, the outcomes of the "Reader Study" and the "Limited Time Annotation Testing" serve as a form of acceptance criteria, where the device's agreement with expert consensus is evaluated.

   Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
   Inter-operator agreement	Strong agreement among expert readers	Confirmed. Experts strongly agreed with one another.
   VX1 correlation with expert annotation (Reader Study)	Acceptable correlation with physician annotation	VX1 adjudication acceptably correlates with physician annotation.
   Period estimation performance	Outperform or be comparable to alternative algorithms	VX1 period estimation algorithm outperformed both FFT-based and AC-based algorithms for noisy/non-periodic electrograms.
   VX1 algorithm accuracy (k-fold cross-validation)	High accuracy	Over 89% accuracy.
   VX1 performance vs. unassisted electrophysiologists	Superior agreement to annotating experts than unassisted humans	VX1 algorithm demonstrated superior performance (agreement to annotating experts) to cardiac electrophysiologists.
   Clinical risk and procedure time	No additional risk or procedure time	Not associated with additional risk or procedure time.
   Comparable performance to predicate's CFAE module	Comparable performance	VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.

2. Sample sizes used for the test set and data provenance:

   • Reader Study: 14,370 electrograms.
   • Period Estimation Algorithm Testing: 2,550 electrograms.
   • Limited Time Annotation Testing: 1,020 electrograms.
   • Clinical Study: 300 patients across 8 centers.
   • Data Provenance: The document states "An OUS clinical study was performed..." indicating that at least some clinical data is from outside the US. The "training database of 275,020 1.5 second annotated electrograms" drew on "anonymized information from a very large database". The nature (retrospective/prospective) is not explicitly stated for all datasets, but the clinical study was likely prospective to evaluate usability and efficacy.

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

   • Reader Study and Limited Time Annotation Testing: 3 independent experts were used to adjudicate the 14,370 electrograms for the Reader Study. For the Limited Time Annotation Testing, 2 annotating experts were used (who reached a consensus). Their specific qualifications beyond "independent experts" and "annotating experts" are not detailed (e.g., years of experience or board certification).
   • "Unassisted" Human Readers in Limited Time Annotation Testing: 28 cardiac electrophysiologists who underwent a "full-day seminar on spatiotemporal dispersion."

4. Adjudication method for the test set:

   • Reader Study: "adjudicated by three independent experts". It doesn't specify if this was a 2+1, 3+1, or simple majority.
   • Limited Time Annotation Testing: "two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus". This suggests a consensus-based adjudication between two experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • A comparative study was done during the "Limited Time Annotation Testing" comparing the VX1 algorithm's performance to that of 28 cardiac electrophysiologists. This fits the description of a multi-reader (28 electrophysiologists) multi-case (1,020 electrograms) study.
   • Effect Size: The document states the "VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms." However, a specific effect size (e.g., AUC difference, sensitivity/specificity improvement, or statistical significance value) is not provided.

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

   • Yes, the "Reader Study" directly compared the VX1's classification to expert annotation, implying a standalone performance evaluation.
   • The "Period estimation algorithm testing" also evaluated the algorithm's performance independently.
   • The k-fold cross-validation is a standalone algorithm performance test.

7. The type of ground truth used:

   • Expert Consensus: The primary ground truth for the Reader Study and Limited Time Annotation Testing was established by "independent experts" or "annotating experts" reaching a consensus on the presence or absence of dispersed intra-cardiac atrial electrograms.

8. The sample size for the training set:

   • The k-fold cross-validation was performed on a "training database of 275,020 1.5 second annotated electrograms."

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

   • The training database drew on "anonymized information from a very large database... of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server". The document does not explicitly state how these 275,020 electrograms were annotated (e.g., by experts, or through a different automated process). However, the context of comparing the algorithm to expert annotations in the validation suggests that expert annotation would be the most robust method for establishing ground truth for training as well. Without explicit mention, it's inferred to be expert-annotated.

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The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.

This document is a 510(k) premarket notification for the CLEARSIGN II Amplifier, which is a Transducer Signal Amplifier and Conditioner. The submission seeks to prove substantial equivalence to a previously cleared device, also named CLEARSIGN II Amplifier (K150235).

The device in question (CLEARSIGN II Amplifier) is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

Acceptance Criteria and Reported Device Performance

The document describes performance data through various verification tests to support a determination of substantial equivalence. While specific quantitative acceptance criteria are not explicitly detailed in a table format, the document states that "No new safety or performance issues were raised during the device testing" and that the testing assures "conformance to the requirements for its intended use."

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is verification testing against design specifications, not a clinical study on patient data.

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

Not applicable. The testing described is design verification (engineering tests), not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set:

Not applicable. This was design verification testing, not a clinical study with subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on identical indications for use and fundamentally similar technological characteristics to a predicate device, with verification testing ensuring no new safety or performance issues. This is not a study comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in essence, the "Performance Data" section describes standalone testing of the device's hardware and software components. The "CLEARSIGN II ECG Offset Test," "Firmware version 2.09 Verification Testing," and "Software Verification Testing" evaluate the device's intrinsic functions without a human-in-the-loop performance assessment.

7. Type of Ground Truth Used:

The ground truth used for the verification testing would be the engineering specifications and expected output parameters for the device's functions (e.g., specific voltage levels for ECG amplification, correct processing logic for firmware, proper software operation). It does not involve expert consensus, pathology, or outcomes data in the medical sense, but rather conformance to defined technical requirements.

8. Sample Size for the Training Set:

Not applicable. This device is an amplifier and conditioner, not an AI or machine learning algorithm that requires a training set of data. The "firmware" and "software" mentioned are likely traditional programmed logic, not adaptive learning models.

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

Not applicable, as no training set (for machine learning) is relevant to this device's development or regulatory submission.

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The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CLEARSIGN II Amplifier:

This document is a 510(k) Premarket Notification submission for a medical device called the CLEARSIGN II Amplifier. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel studies. Therefore, the information provided focuses on comparative testing and adherence to standards rather than traditional clinical trial-style data.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance metrics in the way one might expect for a new, breakthrough device. Instead, the "acceptance criteria" are implied by adherence to established industry standards and successful completion of specific functional tests. The reported "performance" is that the device met these predefined acceptance criteria.

1. Sample size used for the test set and the data provenance:

   • Sample Size:
     • For bench testing: Not specified in terms of number of units or test iterations beyond "testing per standards."
     • For in vivo testing: "In vivo animal testing" is mentioned, implying a biological sample, but the number of animals or specific experimental design is not detailed.
   • Data Provenance: The standard tests (IEC, ISO, etc.) are generally conducted in a controlled laboratory environment. The in vivo animal testing would also be laboratory-based and prospective within the context of the study. The document does not specify a country of origin for the data, but given it's a submission to the FDA (USA), it's likely the testing was conducted in the US or by a facility adhering to US/international standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The studies described are primarily engineering and bench tests against known standards, which typically do not involve human expert adjudication for "ground truth" in the same way clinical image analysis would. For functional tests, "ground truth" is defined by the physical or electrical standards themselves.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned for the type of testing described. Adjudication methods are typically used for subjective assessments or when there is ambiguity in defining a "ground truth" from complex clinical data, which is not the nature of the engineering and functional tests reported here.

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, an MRMC comparative effectiveness study was not done.
   • This device is an amplifier for physiological signals (ECG, pressure transducers), transmitting data to a recording system. It is not an AI-powered diagnostic tool that assists human readers in interpreting complex images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

   • The "performance" of the device is inherently standalone in the sense that its functional capabilities (amplification, conditioning, signal transmission) are tested against engineering specifications. The device itself is an electromechanical component of a larger system (LabSystem PRO EP Recording System). Its performance in isolation (e.g., signal fidelity, noise reduction) is what would be tested, as described by the various IEC and ISO standards. However, it's not an "algorithm-only" device; it's hardware with embedded software.
   • The document implies standalone testing of the amplifier's functionality and its software's performance, but it's within the context of hardware.

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

   • The "ground truth" for these tests is generally defined by established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). For functional tests (like invasive blood pressure or ECG monitoring), the 'truth' would be a precisely known input signal that the device is expected to accurately amplify and condition according to its specifications. For electrical safety, the 'truth' is compliance with safety limits. In a sense, the "ground truth" is the specification itself and the ability of the device to meet it.
   • The "in vivo animal testing" would likely establish safety and basic physiological signal acquisition capability, with "ground truth" being in vivo physiological signals and the absence of adverse events, observed by qualified veterinary or medical staff.

7. The sample size for the training set:

   • Not applicable and not mentioned. This device is not an AI/ML device that requires a "training set." It is an amplifier, and its design is based on engineering principles and standards, not on learning from a dataset.

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

   • Not applicable. As stated above, there is no training set for this type of device.

Summary of Device and Study Context:

The CLEARSIGN II Amplifier is an electromedical device intended to amplify and condition physiological signals (ECG and pressure). The regulatory submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (CLEARSIGN Amplifier, K050006). This means the focus of the studies is to show that the new device has "fundamentally the same technological characteristics" and performs in a safe and effective manner, compliant with current (updated) standards, and does not raise new safety or effectiveness concerns compared to the predicate.

The "studies" performed are primarily:

• Bench testing: Verifying compliance with various electrical, electromagnetic, software, functional, and environmental standards (IEC, ISO, ISTA).
• In vivo animal testing: Likely for general safety and initial physiological data acquisition demonstration.

These types of studies are standard for regulatory clearance of updates or minor modifications to existing device types and are distinct from multi-center clinical trials or AI validation studies that require extensive human expert review or large annotated datasets.

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