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The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap High Resolution Imaging and Mapping System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure.

The AcQMap High Resolution Imaging and Mapping System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box. The AcQMap High Resolution Imaging and Mapping System is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation, and mapping of the atrial chambers of the heart. The AcQMap High Resolution Imaging and Mapping System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording; and Impedance based electrode Localization. The AcQMap High Resolution Imaging and Mapping System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap High Resolution Imaging and Mapping System provides: 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound), Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, Cardiac electrical activity as waveform traces, Contact LAT and voltage amplitude maps Remapping of the chamber at any time during the procedure; and Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. The AcQMap High Resolution Imaging and Mapping System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia. Additionally, the AcQMap High Resolution Imaging and Mapping System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrhythmia without deploying the AcQMap Catheter. The modifications to the AcQMap High Resolution Imaging and Mapping System include software modification and the addition of new accessories to support compatibility with the AcQBlate Force Sensing Ablation System.

The provided text includes general information about the device's classification, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, reported device performance data, or detailed information about the study design elements you requested for a comparative effectiveness study or standalone performance evaluation.

Here's what can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or reported device performance in a table format. It states that "The modified AcQMap High Resolution Imaging and Mapping System was tested to verify that the device meets the established performance specifications" and "The collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System meets its established performance specifications necessary for performance during its intended use." However, it does not detail what these specific performance specifications or criteria are, nor does it present the results against them.

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

• Test set sample size: For the original AcQMap High Resolution Imaging and Mapping System (K170948), the clinical study included 84 patients. This study's results are incorporated by reference for the modified device.
• Data provenance: The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
  • Country of origin: Outside the U.S.
  • Retrospective or prospective: Prospective.

3. 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)

This information is not provided in the document. The document mentions "physicians" using the system to identify arrhythmia sources but does not detail the number or qualifications of experts for establishing ground truth in the clinical study.

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

This information is not provided in the document.

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: The document describes a clinical study "DDRAMATIC-SVT", which demonstrated the substantial equivalence of the original AcQMap system. However, this study did not evaluate human readers with AI assistance versus without AI assistance. The AcQMap system itself (which includes imaging and mapping capabilities) is the device being assessed, not an AI assisting human readers with interpreting external data.
• Effect size: Therefore, no information on the effect size of human reader improvement with AI assistance is provided, as this type of study was not conducted or reported.

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

The document describes the AcQMap High Resolution Imaging and Mapping System as a diagnostic recording system intended for use in an Electrophysiology (EP) Lab, used by physicians. It generates 3-D reconstructions, electrical maps, and displays electrical impulses. The description strongly implies it's a tool for physicians, not a standalone AI algorithm producing diagnoses without human interpretation. Therefore, a standalone (algorithm-only) performance study as you describe would likely not be directly applicable, and no such study is reported in the provided text. The performance assessed is of the system as a whole, which operates in the context of clinical procedures.

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

This information is not explicitly stated. The system is intended to help physicians "identify the source(s) of the arrhythmia" and provides "information about the electrical activity of the heart." While this implies clinical assessment by physicians based on the system's output and potentially other diagnostic tools, the specific method for establishing the definitive "ground truth" for arrhythmias in the study (e.g., confirmed by a separate gold standard, follow-up outcomes, expert consensus) is not detailed.

8. The sample size for the training set

The document describes a modified device being compared to a predicate device (K222209). The necessary clinical testing for the original AcQMap High Resolution Imaging and Mapping System (K170948) is incorporated by reference. There is no mention of a "training set" in the context of AI/machine learning in this document, as the device is not presented as an AI-driven diagnostic algorithm that requires a separate training set. It's a system for imaging and mapping.

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

As there is no mention of a "training set" for an AI algorithm in this context, this information is not applicable/not provided.

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The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

The AcQMap High Resolution Imaging and Mapping System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box. The AcQMap High Resolution Imaging and Mapping System ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart. The AcQMap System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording; and Impedance based electrode Localization. The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides: 3-D cardiac chamber reconstruction – Contact and non-contact (ultrasound), Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, Cardiac electrical activity as waveform traces, Contact LAT and voltage amplitude maps Remapping of the chamber at any time during the procedure; and Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. The AcQMap System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia. Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter. There are no changes to the current mapping data. The modifications to the AcQMap System includes: The addition of a corresponding mV scale in the color bar of charge density amplitude maps; This is an optional tool to provide the physician with a familiar quantitative metric for signal amplitude that may be used to aid the physician's interpretation of the data. User-initiated system checks for common connection errors such as cable disconnections and patch placement locations; This is an optional tool to provide an on-demand assessment of systemmeasured data that may aid the user in troubleshooting of common connection errors. An improvement to the generation of the anatomic surface from ultrasound points; This improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user. This improvement also has the potential to preserve anatomic detail in the resulting shell with the reduction of the geometric artifacts. There are no changes to the current method of ultrasound data gathering or the type of data gathered.

The provided document describes the AcQMap® High Resolution Imaging and Mapping System (K220784) and its substantial equivalence to a predicate device (K212345).

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

Important Note: This submission is for a modification to an already cleared device, asserting substantial equivalence to the previously cleared version. Therefore, much of the performance and clinical data is incorporated by reference from the original clearance (K170948). The current submission focuses on verifying that the modifications do not introduce new safety or effectiveness concerns.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., specific accuracy thresholds for cardiac chamber reconstruction or electrical mapping). Instead, it relies on demonstrating that the modified device conforms to design specifications and does not raise different questions of safety or effectiveness compared to the predicate device.

The document implicitly uses the performance of the predicate device (K212345, which itself relied on K170948) as the baseline for "acceptance." The modifications are described as improvements for "ease-of-use" and to reduce artifacts, without changing the underlying mapping data.

The relevant "performance" reported for the modified device is its conformance to established specifications through verification and validation testing, as detailed in the nonclinical summary.

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

For the modifications in this specific K220784 submission:

• Sample Size: Not applicable in the traditional sense for a clinical test set, as the focus was on nonclinical verification of the modifications.
• Data Provenance: The document does not specify a separate "test set" for the modifications in terms of patient data. The nonclinical bench testing would use various test data as part of software verification/validation and system accuracy testing.

For the original AcQMap System (K170948), which established the clinical effectiveness and is incorporated by reference:

• Sample Size: 84 patients
• Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.

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

Not explicitly stated for the nonclinical testing of the modifications. For the clinical study (DDRAMATIC-SVT), the "ground truth" would be established by the clinicians (e.g., electrophysiologists) performing and interpreting the procedures, but specific expert count or qualifications aren't provided in this summary.

4. Adjudication method for the test set

Not explicitly stated. Given that the modified device's clinical performance is based on an incorporated-by-reference study (DDRAMATIC-SVT) which demonstrated substantial equivalence, specific adjudication methods for a novel clinical test set of the modified device are not detailed as no new clinical study was required for this particular submission.

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 Study: Not explicitly mentioned or described. The AcQMap System is a diagnostic and mapping system, not specifically an AI-driven interpretation tool in the context of "human readers improving with AI assistance." Its primary function is to visualize chamber anatomy and electrical impulses, guiding physician decisions.
• Effect Size: Not applicable in the context of this submission.

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

The AcQMap System is described as a "diagnostic recording system" that aids physicians by providing "information about the electrical activity of the heart and about catheter location during the procedure." While it performs automated tasks like 3D reconstruction and mapping, it is presented as a tool for physician use, not a standalone diagnostic AI. Therefore, a standalone algorithm-only performance study in the absence of human interpretation isn't directly relevant to its intended use as described. The system generates data and visualizations that physicians interpret.

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

For the clinical study (DDRAMATIC-SVT) incorporated by reference, the "ground truth" for evaluating the system's ability to identify complex arrhythmias and guide procedures would likely be clinical outcomes and expert interpretation of the electrical maps and other diagnostic information generated by the system during electrophysiology procedures. The document states the study "demonstrated that the AcQMap System is substantially equivalent to the predicate device," implying its ability to accurately guide diagnosis and therapy, which would be based on clinical judgment and observed therapeutic success.

For the nonclinical testing for the modifications, ground truth would be established by design specifications and known physical/electrical properties for accuracy validation.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning. The AcQMap system is a diagnostic imaging and mapping system, not described as being based on machine learning from a training dataset in the same way an AI diagnostic algorithm might be. The "improvements to the generation of the anatomic surface from ultrasound points" are described as an algorithm refinement, but no training set details are provided.

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

Not applicable as no "training set" is described for this device in the context of machine learning.

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The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.

When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

AND

When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

OR

When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

The AcQMap High Resolution Imaging and Mapping System, Model 900100 operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.

The AcQMap High Resolution Imaging and Mapping System, Model 900100 ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging navigation and mapping of the atrial chambers of the heart.

The AcQMap System hardware consists of three functional subsystems:

• . Ultrasound imaging,
• . ECG and EGM recording; and
• . Impedance based electrode Localization.

The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides:

• . 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound),
• Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, .
• . Cardiac electrical activity as waveform traces,
• . Contact LAT and voltage amplitude maps
• . Remapping of the chamber at any time during the procedure; and
• . Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.

The AcQMap System, Model 900100 is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.

Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.

The modifications to the AcQMap System, Model 900100 includes AcQTrack™ Conduction Pattern (Conduction Pattern Recognition) feature, Composite Mapping feature and Complex Fractionated Atrial Electrogram (CFAE) calculation that adds additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered.

The provided text describes a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System, Model 900100. This submission focuses on modifications to the software features of an existing device, adding "AcQTrack™ Conduction Pattern (Conduction Pattern Recognition), Composite Mapping, and Complex Fractionated Atrial Electrogram (CFAE) calculation". The core system and its existing mapping capabilities remain unchanged.

Therefore, the acceptance criteria and performance data provided relate primarily to the demonstration of substantial equivalence for these software modifications to the previously cleared predicate device (K193013), and ultimately to the original AcQMap System cleared under K170948.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for the new software features in terms of specific metrics like sensitivity or specificity. Instead, the performance is demonstrated through verification and validation activities showing that the additional features function as intended and do not introduce new safety or effectiveness concerns, maintaining substantial equivalence to the predicate.

The "acceptance criteria" here are implicitly focused on:

• The new software features (AcQTrack Conduction Pattern, Composite Mapping, CFAE calculation) performing their intended post-processing and data summarization functions correctly.
• The overall system maintaining its established safety and performance characteristics, as demonstrated by the predicate device (K193013) and the original device (K170948).
• No new questions of safety or effectiveness being raised by the modifications.

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

• For the modifications (new software features): The text mentions these features were "validated with both simulation and clinical data" but does not specify the sample size or provenance for this validation specifically for the new features.
• For the original AcQMap System (K170948), which established the foundational equivalence:
  • Sample Size: 84 patients.
  • Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.

3. 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)

The document does not provide details on the number or qualifications of experts used to establish ground truth for either the validation of the new software features or the clinical study of the original AcQMap system. The new features are designed to "expedite the physician's interpretation of the data based on physician-established criteria," implying clinical expert interpretation is central, but specifics are missing.

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

The document does not describe any specific adjudication method for establishing ground truth or evaluating the test sets.

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

The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The new features are described as "optional tools to provide a summarization of existing data to expedite the physician's interpretation," suggesting an assistive role, but no formal comparative study of human performance improvement is reported here.

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

The document does not explicitly describe a standalone performance study of the new software features (AcQTrack, Composite Mapping, CFAE calculation) without human-in-the-loop. These features are presented as "additional post processing and summary data display options" to assist physician interpretation rather than operating purely standalone. The core mapping system, however, performs its functions (reconstruction, electrical mapping, localization) without direct human intervention in the data acquisition/initial processing.

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

The document does not explicitly state the type of ground truth used to evaluate the new software features. For the clinical study of the original device (K170948), it refers to "electrophysiology procedures" in patients and assessing therapy, suggesting that clinical observations and outcomes from these procedures would inherently form the basis of ground truth for assessing the system's mapping and imaging capabilities. However, specific methods for establishing ground truth (e.g., expert consensus on specific arrhythmia origins) are not detailed.

8. The sample size for the training set

The document does not provide a sample size for any training set. Since the modifications are described as "additional software display features" and post-processing tools, and no new method of data gathering is mentioned, it's possible that the development of these algorithms leveraged existing clinical data previously collected for the predicate device, but this is not specified.

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

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

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