Search Results

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 Catheters, the AcQMap High Resolution Imaging System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber 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 (hereafter referred to as the AcQMap System) operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.

The AcQMap 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 System hardware consists of three (3) functional subsystems:

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

The AcQMap System is used in conjunction with the AcQMap 3D Imaging and Mapping Catheter (hereafter referred to as the AcQMap Catheter). The AcQMap System provides:

• . 3-D cardiac chamber reconstruction – Contact and non-contact (ultrasound),
• 3-D 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.

In addition, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one (1) 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 modifications to the hardware of the AcQMap System nor its accessories. The modifications to the AcQMap System are specific to the software, which include:

• The addition of the feature, Dynamic Referencing. Dynamic Referencing actively monitors impedance-based stability events like catheter drift or shift. Users will be offered guided notifications when shifts or drifts are automatically detected. Dynamic Referencing combines the capabilities of a Virtual Position Reference (VPR) and a Physical Position Reference (PPR), allowing them to be used together simultaneously. It is designed to be used instead of VPR or PPR alone. VPR and PPR remain available as options and
• Updated elements of the user interface to make it easier for the user to conduct a variety of actions within the software.

The provided text focuses on the substantial equivalence of the AcQMap High Resolution Imaging and Mapping System (K231091) to its predicate device (K222209), with an emphasis on changes to software and user interface. It states that "no further clinical testing is required" for the subject device and refers to clinical testing performed for the original AcQMap System (K170948).

Therefore, the acceptance criteria and study information will be derived from the description of the original AcQMap System's clinical study (DDRAMATIC-SVT) referenced in the document.

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

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

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a table format for the subject device (K231091) or for the original device (K170948) from its clinical study. Instead, it makes a general statement that the results of the DDRAMATIC-SVT study "demonstrated that the AcQMap System is substantially equivalent to the predicate device."

For the subject device (K231091), the modifications are described as improving "ease-of-use of some system capabilities" and having "no changes to the current mapping data." The conclusion is that "the subject device meets its established performance specifications necessary for performance during its intended use."

Without specific metrics or thresholds, a direct table of acceptance criteria and performance cannot be created from this text.

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

• Sample Size: 84 patients
• Data Provenance: Prospective, non-randomized, open-label study conducted at eight (8) 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

The document does not specify the number of experts or their qualifications for establishing the ground truth in the DDRAMATIC-SVT study. It only mentions that the system displays electrical impulses and maps for physicians to "identify the source(s) of the arrhythmia."

4. Adjudication method for the test set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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 describes the clinical study (DDRAMATIC-SVT) as a non-randomized, open-label study to establish substantial equivalence. It does not indicate that it was a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance, nor does it provide any effect size concerning human reader improvement. The focus is on the device's diagnostic capabilities, not on direct physician performance improvement with the device.

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

The document describes the AcQMap System as "intended to be used by physicians" to reconstruct chambers and display electrical impulses and maps to identify arrhythmia sources. This implies a human-in-the-loop performance context. The text does not mention any standalone algorithm-only performance assessment.

7. The type of ground truth used

The text describes the AcQMap System's purpose as helping physicians "identify the source(s) of the arrhythmia" using "charge density-based or voltage-based maps." This strongly suggests that the ground truth for the clinical study would be derived from electrophysiological measurements and clinical consensus regarding the arrhythmia source, but it does not explicitly state "expert consensus," "pathology," or "outcomes data." However, given the context of electrophysiology procedures, expert interpretation of electrophysiological data would be the most likely form of ground truth.

8. The sample size for the training set

The document focuses on the clinical validation study (DDRAMATIC-SVT) for the original device (K170948), which served as the test set for demonstrating substantial equivalence. It does not provide information about a separate "training set" used for developing the software features or maps of the AcQMap System.

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

As no training set is explicitly mentioned, how its ground truth was established is not described in the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

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 Catheters, 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 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 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 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 (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 arrythmia without deploying the AcQMap Catheter. The modifications to the AcQMap High Resolution Imaging System include the addition of new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and DiamondTemp™ Ablation Generator.

Below is an analysis of the provided text regarding the AcmMap High Resolution Imaging and Mapping System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission does not specify numerical acceptance criteria for the device's performance regarding imaging, mapping accuracy, or specific clinical outcomes. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (AcQMap High Resolution Imaging and Mapping System, K220784) and the original version of the system (K170948).

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly to the predicate/original device and meets established non-clinical performance specifications.

Note: The document explicitly states "The collective results of the nonclinical testing... demonstrate that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device." This implies the performance is at least equivalent to the predicate.

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

• Nonclinical Testing Test Set (Modified Device): Not explicitly stated as a number of devices. The description implies testing was conducted on "the modified AcQMap High Resolution Imaging and Mapping System" to verify specifications. It's likely one or a few units were tested for each specific bench test (e.g., RF attenuation, waveform fidelity).
• Clinical Testing Test Set (Original Device, K170948, incorporated by reference): "84 patients".
• Data Provenance (Clinical Study): "prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S." This indicates the data is prospective and from international sites.

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

The provided document does not specify the number or qualifications of experts for establishing ground truth.

• For the nonclinical bench testing, "ground truth" would be engineering specifications and measurements.
• For the clinical study (DDRAMATIC-SVT), it's a study on "Assesment of Therapy In Complex Supraventricular Tachycardia," suggesting clinical outcomes and electrophysiological assessments would be the standard. The direct role of external experts in establishing "ground truth" as a separate process from the study conduct itself is not detailed. Standard clinical trials rely on physician diagnoses and assessments, but the specific process for ground truth establishment by an independent panel is not mentioned.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, either for nonclinical testing or for the clinical study incorporated by reference. Clinical trials usually involve endpoint adjudication, but the details are not included here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned. The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study designed to assess the performance of the original AcQMap System (K170948) and demonstrate its substantial equivalence. It does not appear to be a study comparing human readers with and without AI assistance to measure an effect size.

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

The document primarily focuses on the system as a diagnostic recording system, capable of imaging, navigation, and mapping for use by physicians to identify sources of arrhythmia. The outputs (3-D reconstructions, electrical maps, catheter positions, waveforms) are intended to assist physicians.

While there are "System Accuracy Testing" and "Map Accuracy Evaluation" as part of the non-clinical testing, these likely assess the technical accuracy of the algorithms in generating mapping data against defined inputs, rather than an "algorithm only" clinical performance study in the sense of making diagnostic decisions without human interpretation. The system is designed to provide information to the clinician, not to make a standalone diagnosis.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Nonclinical Testing: Engineering specifications, physical measurements, and established safety standards (IEC 60601-1, IEC 60601-1-2, IEC 62366-1, etc.) would serve as ground truth for these tests.
• Clinical Study (DDRAMATIC-SVT): The study title "Assessment of Therapy In Complex Supraventricular Tachycardia" suggests the ground truth would involve clinical outcomes related to the diagnosis and treatment of arrhythmias, likely including electrophysiological assessments and patient responses to therapy. The specifics of how "ground truth" was established (e.g., confirmed arrhythmia diagnosis by an independent panel, successful ablation outcomes) are not detailed in this excerpt.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The device is described as "Programable diagnostic computer and Ultrasonic pulsed echo imaging system," but the application is for a modification to an existing system (adding connectivity accessories). The previous versions of the system (K220784 predicate and K170948 original) would have undergone validation, but whether a machine learning model with a distinct "training set" was used for the core mapping functionalities is not specified in this document. Given the nature of previous predicate devices for mapping systems, it's less likely to be a deep learning model requiring a large training set in the modern AI sense, and more likely based on signal processing and physics-based reconstruction algorithms.

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

Since no explicit training set is mentioned for an AI/ML component, the method for establishing its ground truth is not described. For traditional signal processing and reconstruction algorithms, "ground truth" during development often comes from simulated data, phantom studies, and expert-validated real-world data used for algorithm design and initial tuning. These details are not in the provided document.

Ask a specific question about this device

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.

Ask a specific question about this device

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 addition of new accessories (cables and adapters) to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and compatible RF Ablation Generators.

This FDA 510(k) summary document focuses on demonstrating substantial equivalence of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 (K212345) to its predicate device (K201015). The modifications primarily involve the addition of new accessories (cables and adapters) to facilitate connectivity with commercially available RF Ablation Generators. Since the changes do not impact the core hardware or software of the original system, the document refers to the clinical testing performed for the original AcQMap System (K170948).

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance based on the clinical study. Instead, it states that the "collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use."

For the clinical study, the reported performance is qualitative: "the results for 84 patients demonstrated that the AcQMap System is substantially equivalent to the predicate device." This implies that the device performed comparably to existing, legally marketed devices.

The document lists various non-clinical tests that were performed, either repeated for the modified device or incorporated by reference. These tests would have their own internal acceptance criteria, but these are not specified in this document. Examples of these non-clinical tests include:

• Third party system Compatibility with AcQMap system, Model 900100 Testing
• System RF Attenuation characterization
• Therapeutic Waveform Fidelity Assessment
• Safety Testing
• Packaging Testing
• Inspection and Labeling Review
• Common Mode Choke (CMC) performance verification Testing
• In-vitro Localization Accuracy Study
• Transportation Testing
• AcQMap Verification Testing
• System Accuracy Testing
• Electromagnetic Compatibility and Electrical Safety Testing
• AcQMap Catheter Validation Testing-Animal Study
• Accuracy Validation Testing Animal Study
• Software Verification and Validation
• Clinical Simulation (Reliability)
• Map Accuracy Evaluation

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

• Sample Size for Test Set: 84 patients
• Data Provenance: The study was a 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 Qualifications of those Experts

The document does not specify the number of experts used to establish ground truth in the clinical study or their qualifications. The study focused on demonstrating "substantially equivalent" performance to a predicate device, but the method for assessing this equivalence (e.g., comparison against established diagnostic standards or expert interpretation) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The document describes the system as "computer-based" and capable of "imaging, navigation and mapping," and "displaying electrical impulses as either charge density-based or voltage-based maps." However, its primary function appears to be diagnostic support for electrophysiology procedures, not an AI-assisted diagnostic interpretation tool with a human-in-the-loop comparison.

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

The document does not explicitly describe a standalone algorithm-only performance study. While it mentions the computer-based nature of the system and its mapping capabilities, the "Indications for Use" clearly state it's "intended for use in patients for whom electrophysiology procedures have been prescribed" and "intended to be used to reconstruct... and displaying electrical impulses." This implies a system that provides information for a physician to interpret and act upon, rather than an independent diagnostic algorithm.

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 in the clinical study (DDRAMATIC-SVT). Since the study aimed to demonstrate "substantially equivalent" performance to a predicate device in the context of "mapping and assessment of therapy in complex supraventricular tachycardia," it's highly probable that electrophysiological data agreed upon by treating clinicians, potentially involving follow-up on therapeutic outcomes, served as the de facto "ground truth" for assessing the system's accuracy in identifying arrhythmias. However, this is an inference based on the nature of the device and study.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set because it describes a device that is a diagnostic recording system, not an AI/ML device that requires a distinct training and test set. The clinical study mentioned (DDRAMATIC-SVT) is for validation, not for training.

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

As no training set is mentioned for an AI/ML device, this question is not applicable to the information provided.

Ask a specific question about this device

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.

Ask a specific question about this device

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 (cleared under K170819). 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 AcQMap System is used with the AcQMap Patient Electrode Kit.

The provided text describes a 510(k) premarket notification for the "AcQMap High Resolution Imaging and Mapping System, Model 900100". The submission states that this is a modification to an already cleared device (K193013), specifically replacing the cleared Patient Electrode Kit with a new one (800605). Therefore, the study details predominantly refer to the clinical testing of the original AcQMap System (K170948), and the current submission includes non-clinical performance data for the modified Patient Electrode Kit.

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

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

The document does not provide a specific table detailing acceptance criteria for the modified device and its performance in a quantitative manner. Instead, it states that "All testing performed met the established performance specifications" for the nonclinical tests. For the clinical study of the original device, it
states the system was "safe and effective."

Here's a summary of the non-clinical tests performed on the new Patient Electrode Kit:

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 clinical study of the original AcQMap System (K170948):

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

For the nonclinical tests for the modified Patient Electrode Kit, the sample sizes are not explicitly stated, but the tests were performed as part of design verification.

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 clinical study for the original device assessed the system's "safety and effectiveness," which likely involved clinical endpoints rather than ground truth established by a panel of experts for a diagnostic algorithm in the way a reader study would.

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

A MRMC comparative effectiveness study is not mentioned in the document. The clinical study was focused on the safety and effectiveness of the AcQMap System itself, not specifically on human reader improvement with AI assistance. The AcQMap System is described as displaying electrical impulses and information about electrical activity and catheter location, which assists physicians, but the study described does not quantify physician improvement.

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 is "intended for use in the Electrophysiology (EP) Lab" and "used by physicians." This implies human-in-the-loop performance rather than a standalone algorithm. The device displays information to assist physicians in identifying arrhythmia sources.

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

For the clinical study of the original AcQMap System (K170948), the study aimed to demonstrate "safety and effectiveness" for its intended use in "complex arrhythmias." This suggests the ground truth was likely clinical outcomes data related to the efficacy of the diagnostic/mapping capabilities in guiding procedures and potentially the success of therapy for supraventricular tachycardia (SVT), as the study was entitled "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)". Specific details on how ground truth was established for mapping accuracy or arrhythmia identification are not provided.

8. The sample size for the training set

The document does not specify a training set size. The submission focuses on the clinical validation of a previously cleared device (K170948) and nonclinical testing of a component modification. If machine learning was used in the development of the AcQMap System's algorithms, the data used for training is not detailed in this document.

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

This information is not provided in the document.

Ask a specific question about this device

The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.

The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector, as shown in Figure II.I. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations and directions of interest within the heart. Refer to Figure 10.1 for images of the device.

The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability.

The provided text describes modifications to an existing device, the AcQMap 3D Imaging and Mapping Catheter, and asserts its substantial equivalence to a predicate device. It does not contain acceptance criteria or a study directly proving the modified device meets them in the traditional sense of a clinical performance study for AI devices. Instead, it relies on substantial equivalence to the predicate device, which had prior clinical testing.

Therefore, the following information will be extracted or inferred to the best of my ability from the provided document, addressing each of your points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the modified device in the context of clinical effectiveness. Instead, it relies on the predicate device's clinical performance and non-clinical testing for the modified device to demonstrate substantial equivalence.

The "acceptance criteria" for this submission are implicitly that the modified device does not raise new questions of safety or effectiveness compared to the predicate device. The reported performance relies on the predicate device's clinical study and the modified device's non-clinical testing.

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

For the modified device, no clinical test set is described. The submission relies on non-clinical (bench) testing.
For the predicate device (clinical testing 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 Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The document refers to the "DDRAMATIC-SVT" study for the predicate device but does not detail how ground truth was established within that study or the number/qualifications of experts involved. Given it's an invasive medical device for mapping arrhythmias, the "ground truth" would likely involve comparison to established clinical methods and expert interpretation of the complex arrhythmia data, but specifics are absent here.

4. Adjudication Method 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, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device (AcQMap 3D Imaging and Mapping Catheter) is an imaging and mapping catheter for collecting ultrasound data and electrical impulses, not an AI-assisted diagnostic or interpretation tool for human readers in the traditional sense of an MRMC study. It collects data that physicians then use. The document does not describe any human-in-the-loop performance evaluation or AI assistance.

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

This is not applicable in the context of an "algorithm only" performance that would typically be seen for AI products. The device itself is designed to function and capture data. The "standalone" performance here refers to the device's ability to "collect ultrasound data for visualizing the selected chamber and recording electrical impulses," which was assessed through non-clinical accuracy and functional testing and clinically by its ability to facilitate identification of complex arrhythmias, as demonstrated by the predicate device's clinical study. The device itself performs the data acquisition, which is then presented to clinicians.

7. The Type of Ground Truth Used

For the predicate device's clinical study (DDRAMATIC-SVT), the document does not explicitly state the type of ground truth used. However, for a device intended to help identify "complex arrhythmias that may be difficult to identify using conventional mapping systems alone," the ground truth would likely involve:

• Clinical Outcomes/Resolution: Efficacy in guiding successful ablation or treatment of arrhythmias.
• Expert Consensus/Diagnosis: Comparison of the mapping system's output to expert electrophysiologist (EP) diagnoses using established clinical practices or other validated mapping techniques.

For the non-clinical testing of the modified device, the "ground truth" would be against engineering specifications and known physical properties and measurements (e.g., dimensional accuracy, electrical performance, acoustic output measurements).

8. The Sample Size for the Training Set

This device is not described as an AI/ML device that requires a training set in the conventional sense. Therefore, information on a "training set" and its size is not applicable/provided.

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

As above, this is not applicable as the device is not presented as an AI/ML product with a training set.

Ask a specific question about this device

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 (cleared under K170819). 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.

SuperMap is an adjunct mapping mode to the standard, single position non-contact mapping that makes use of a timing reference (i.e. regular, stable signals from a CS catheter) to time-align measurements from multiple positions throughout the chamber (similar to the manner in which signals are time-aligned when contact mapping).

SuperMap slightly modifies the current workflow for regular rhythms by allowing the user to efficiently collect significantly more electrical data by roving (AKA "hovering") the AcQMap Catheter throughout the chamber and aligning the electrical data from multiple positions to a timing reference.

Here's a breakdown of the acceptance criteria and study information for the AcQMap High Resolution Imaging and Mapping System, Model 900100, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. However, it states that "the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 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, Model 900100 meets its established performance specifications necessary for performance during its intended use."

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AcQMap High Resolution Imaging and Mapping System, Model 900100 (K191392)) by showing that the modified device's performance is either identical or does not raise different questions of safety or effectiveness. Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence.

Here's an interpretation based on the "Comparison of Technological Characteristics" tables (Table 1, Table 2, Table 3), where "Identical" implies meeting the same performance as the predicate.

Important Note on "Identical" Rationale: The document states "Identical" for several parameters where the numerical values presented for the subject and predicate device are different (e.g., Localization Output, ECG & EGM Input). This indicates that the manufacturer argues these differences are not significant enough to raise new questions of safety or effectiveness, thus maintaining substantial equivalence. For the purpose of this table, I've listed the reported performance for each device, while acknowledging the "Identical" rationale given.

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

• Sample Size for Test Set:
  • Nonclinical Testing: Not explicitly stated as a single "test set" sample size. Various bench tests were performed:
    • Software Verification and Validation
    • SuperMap Mapping Validation Testing Animal Study (specific number of animals not provided in this excerpt)
    • Clinical Simulation (Reliability)
    • Map Accuracy Testing
  • Clinical Testing: The clinical study for the original AcQMap System (K170948), which is referenced for the modified device, involved 84 patients.
• Data Provenance:
  • Nonclinical Testing: Performed by Acutus Medical, Inc. (device manufacturer).
  • Clinical Testing (for referenced original device): Conducted at eight clinical sites outside the U.S.
  • Retrospective or Prospective: The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study.

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

• The document does not provide information on the number or qualifications of experts used to establish ground truth for either the nonclinical (animal) studies or the clinical (human) study.

4. Adjudication Method (for the test set)

• The document does not specify an adjudication method for either the nonclinical or clinical test sets. Given it was an "open-label" clinical study, a blinded adjudication method is unlikely to have been the primary approach.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
• The device described is an "AcQMap High Resolution Imaging and Mapping System" which is a diagnostic recording system for electrophysiology procedures, capable of imaging, navigation, and mapping. While it uses "charge density-based or voltage-based maps of complex arrhythmias," it's not positioned as an AI-assisted diagnostic tool that helps human readers interpret images or data, but rather as a system that generates its own electrical maps and anatomical reconstructions. The "SuperMap" feature is an adjunct mapping mode that optimizes data collection.
• Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not directly apply as a study objective or outcome discussed in this document.

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

• The document describes the "AcQMap System" as a standalone diagnostic recording system that performs imaging, navigation, and mapping, and generates 3-D cardiac chamber reconstructions and electrical maps. The "SuperMap" feature is also inherent to the system's mapping capabilities.
• The nonclinical tests like "Software Verification and Validation," "SuperMap Mapping Validation Testing Animal Study," and "Map Accuracy Testing" would implicitly involve evaluation of the algorithm's performance in generating these outputs without direct human intervention in the mapping process itself, though human clinicians operate the system and interpret its results.
• So, while not explicitly called a "standalone study" in the context of an AI algorithm, the system's core mapping and reconstruction functions operate algorithmically.

7. The Type of Ground Truth Used

• Nonclinical (Animal Study): Not explicitly stated, but for "SuperMap Mapping Validation Testing" and "Accuracy Validation Testing," ground truth would likely involve direct physiological measurements, known anatomical structures, and perhaps comparison to established gold standard mapping techniques within the animal model.
• Clinical Study (DDRAMATIC-SVT for original device): Not explicitly stated. For "Assessing Therapy In Complex Supraventricular Tachycardia," ground truth for efficacy would typically involve successful treatment outcomes, cessation of arrhythmia, or correlation with conventional electrophysiological measurements. Safety would be evaluated based on adverse event rates.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate "training set" sample size. This is a 510(k) submission for a medical device that appears to be based on established biophysical principles and signal processing, rather than a deep learning AI model that requires large labeled training datasets in the typical sense. The term "Software Verification and Validation" suggests traditional software engineering practices were applied.

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

• As no training set is explicitly mentioned or detailed in the context of AI/machine learning, this information is not provided in the document. The referenced clinical and nonclinical studies serve as validation for the device's performance, not as sources for a training set.

Ask a specific question about this device