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 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 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

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
• o 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,
• o 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 modified 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 coording 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 provided text is a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System, Model 900100. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data for a new AI/ML algorithm.

Therefore, much of the requested information regarding acceptance criteria, multi-reader multi-case studies, and specific performance metrics of an AI model cannot be extracted directly from this document. This document primarily discusses the safety and effectiveness of a medical device (hardware/software system) for cardiac imaging and mapping, not an AI/ML algorithm requiring rigorous clinical validation for its own performance.

However, I can extract information related to the device's validation and the high-level assessment of its performance.

Here's what can be gathered, with limitations noted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific quantitative acceptance criteria or performance metrics in a tabular format as would be expected for an AI/ML algorithm's clinical validation study (e.g., sensitivity, specificity, AUC). Instead, it states that "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" and that the clinical study "demonstrated that the AcQMap System is safe and effective for its intended use."

The document focuses on "functional and performance characteristics" of the system as compared to its predicate, rather than an AI's accuracy against a ground truth.

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 dipole 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.

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 Model, 900100 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 imaging,
• Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
• Cardiac electrical activity as waveform traces,
• Remapping of the chamber at any time during the procedure; and
• Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.

The AcQMap System. Model 900100 is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, workstation and an auxiliary interface box. 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.

The provided text describes a 510(k) premarket notification for the AcQMap High Resolution Imaging and Mapping System, Model 900100. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (AcQMap Model 900000, K170948) rather than presenting a de novo clinical study with specific acceptance criteria and detailed performance of the new device against those criteria.

Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving the device meets them, especially in the context of typical AI/ML device performance metrics (e.g., sensitivity, specificity, AUC), is not explicitly available in the provided document. The document states that "no further clinical testing is required" for the subject device because the clinical testing conducted for the original AcQMap System (K170948) is incorporated by reference.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative acceptance criteria for the new device (Model 900100) or its specific performance against them. Instead, it relies on the predicate device's prior clearance and demonstrates the new model's substantial equivalence through:

• Identical Indications for Use: The most crucial "acceptance criterion" is that the new device performs identically to the predicate for the same intended use.
• Performance Testing: "Complete performance testing conducted by Acutus demonstrates that the AcQMap System, Model 900100 performs as intended and that there are no different questions of safety or effectiveness." This statement implies that the acceptance criterion for the new device's performance is that it is comparable to the predicate for all evaluated characteristics and that any differences do not introduce new safety or effectiveness concerns.

2. Sample Size for Test Set and Data Provenance:

• Test Set (for Model 900100): The primary testing for the Model 900100 involved "bench testing," "verification testing," "accuracy testing," and "animal testing." No specific "test set" in terms of patient data is mentioned for the new device, as it leverages the clinical study for the predicate.
• Clinical Study (for Predicate K170948):
  • Sample Size: "84 patients"
  • Data Provenance: "prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S." (The specific countries are not mentioned beyond "outside the U.S.") The study was clinical, implying prospective human data collection.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not detail how ground truth was established for the 84-patient clinical study, nor does it mention the number or qualifications of experts involved in establishing it. Given the nature of electrophysiology procedures, it is highly likely that experienced electrophysiologists served as the arbiters of truth (e.g., successful identification of arrhythmia sources, accurate anatomical reconstruction) in the context of the overall procedure outcome.

4. Adjudication Method:

• Not specified.

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

• The document describes a clinical study for the predicate device that evaluated its safety and effectiveness. It does not explicitly mention an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size for such an improvement. The device's function is more akin to an imaging and mapping tool for electrophysiology procedures, rather than an AI diagnostic algorithm assisting human readers in interpreting images.

6. Standalone Performance (Algorithm Only):

• The document describes the performance of the "AcQMap System" itself, which is a diagnostic recording system including software and hardware. The "Algorithm" is integrated into the system for "displaying electrical impulses as either dipole density-based or voltage-based maps" and "reconstructing the selected chamber from ultrasound data." The "performance data" section focuses on the system as a whole (e.g., "System Accuracy Testing", "Software Verification and Validation"). No separate "algorithm-only" performance is detailed, as the algorithm's utility is tied to its display and mapping functions within the system.

7. Type of Ground Truth Used:

• For the predicate device's clinical study (DDRAMATIC-SVT), the ground truth would likely be established by the clinical outcomes and procedural success in "identifying the source(s) of the arrhythmia" and successful electrophysiology procedures, based on the expert assessment by the clinicians at the study sites. This would fall under the category of outcomes data and expert clinical assessment. The document states that the study "demonstrated that the AcQMap System is safe and effective for its intended use," implying clinical endpoints.

8. Sample Size for Training Set:

• Not specified. The document does not provide details on the training methodology or data used for any machine learning components within the device.

9. How Ground Truth for Training Set Was Established:

• Not specified. As no training set details are provided, the method of establishing ground truth for it is also unknown from this document.

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 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 dipole 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.

The AcQMap System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation, the AcQMap Patient Interface Unit, and the AcQMap Ablation Interface Unit.

The AcQMap® High Resolution Imaging and Mapping System ("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 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. The AcQMap System provides:

• 3-D cardiac chamber reconstruction imaging,
• Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
• Cardiac electrical activity as waveform traces,
• Remapping of the chamber at any time during the procedure; and
• Three-dimensional, dipole density-based maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.

The AcQMap System is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, and a workstation. 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.

The provided document is a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System. This submission aims to clear an updated version of an already cleared device (K170948) with new software features (Anatomic Reference, Markers Enhancement, and Graphical User Interface Refresh). The core device and its indications for use remain identical to the predicate device.

Given that this is a 510(k) for an updated version of a previously cleared device with new software features, the acceptance criteria and performance data provided focus on demonstrating that these new features do not raise new questions of safety or effectiveness and that the overall system continues to meet its established performance specifications. The document mainly highlights that the indications for use, technological characteristics (beyond the software updates), and safety standards are identical to the predicate device. Therefore, the "acceptance criteria" discussed are largely based on the established safety and performance of the predicate device, supplemented by testing of the new software features.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations inherent in this type of FDA document (which summarizes testing rather than providing detailed study protocols or results):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that the device was tested to "ensure that it conforms to the design specifications" and that the "results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use."

The updated software features (Anatomic Reference, Markers Enhancement, Graphical User Interface Refresh) are evaluated to ensure they do not alter the fundamental safety or effectiveness. The core "acceptance criteria" are implied to be the successful demonstration that the device (with these updates) continues to meet safety and performance standards equivalent to the predicate device.

Implied Acceptance Criteria and Performance Summary:

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

• Clinical Test Set Sample Size: 84 patients.
• Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. (The specific countries are not mentioned).

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, nor does it detail their qualifications. The study focused on the device's ability to "gather data to create right and/or left atrial dipole density activation maps," implying that the "ground truth" might be related to the device's own generated maps and system performance metrics rather than a direct comparison to an external expert-adjudicated "true" diagnosis or condition, especially since it's a diagnostic mapping system.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical test set data from the DDRAMATIC-SVT study. Given it's a diagnostic system, adjudication would typically involve expert interpretation of the generated maps, but this detail is not provided.

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

No, an MRMC comparative effectiveness study is not explicitly mentioned. The study "DDRAMATIC-SVT" was a single-arm study to demonstrate the device's safety and performance, not a comparison against human readers or other systems. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

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

Yes, the bench and non-clinical testing sections imply standalone performance evaluation.

• "System Accuracy Testing"
• "AcQMap Verification Testing"
• "Software Verification and Validation"
• "Electromagnetic Compatibility and Electrical Safety Testing"
  These tests evaluate the device's intrinsic performance characteristics without direct human-in-the-loop diagnostic interpretation in the context of a clinical decision. The clinical study, while involving human operators, still assesses the system's ability to generate data and maps as intended. The "algorithm" for generating the maps is part of the "system" being tested.

7. The Type of Ground Truth Used

For the clinical study: The "ground truth" seems to be intrinsic to the device's function – its ability to "gather data to create right and/or left atrial dipole density activation maps." The study assessed whether the system could effectively perform this function and whether it was safe. It's essentially using the device's own output as its "performance metric" against its design intent, rather than comparing it to an independent, external gold standard like pathology or long-term outcomes to validate diagnostic accuracy.

For bench and non-clinical testing: The ground truth would be based on engineering specifications, established test methods, and potentially simulated data or measurements from phantoms.

8. The Sample Size for the Training Set

The document does not provide details about a "training set" or "validation set" in the context of an AI/ML algorithm being developed. The AcQMap System is described as a "diagnostic recording system" and "computer-based system," but the documentation focuses on its substantial equivalence to a predicate device and verification/validation testing of its software features rather than an AI development paradigm.

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

Since a "training set" for an AI/ML algorithm is not explicitly mentioned, the method for establishing its ground truth is not provided. The development process described aligns more with traditional software verification and validation where specifications define the expected behavior.

Ask a specific question about this device