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The FlexCath Cross™ Transseptal Solution is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

FlexCath Cross™ combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). FlexCath Cross" consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of FlexCath Cross™ is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of FlexCath Cross™. The needle is affixed to a springtensioned actuator in the handle of FlexCath Cross™ that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. FlexCath Cross™ is for single-use only and is provided sterile.

Due to the nature of the device described in the provided text (a catheter introducer - FlexCath Cross™ Transseptal Solution), the acceptance criteria and study detailed are primarily focused on engineering performance and material safety rather than diagnostic accuracy or clinical outcomes in the way often associated with AI/ML-based medical devices. Therefore, many of the typical questions for AI/ML device studies (like those related to expert adjudication of ground truth, effect size with AI assistance, or distinction between training/test sets for algorithm performance) are not applicable here.

The document describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. The core of the acceptance criteria is demonstrating that the modified device performs as safely and effectively as the predicate device.

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 present a table of "acceptance criteria" with precise numerical thresholds for each test. Instead, it states that "All necessary bench testing was conducted on the additional models FlexCath Cross™ to support a determination of substantial equivalence to the predicate device" and that the "collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device."

The tests performed and their general outcomes (implied to be successful for showing substantial equivalence) are:

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

The document refers to "bench testing" and "non-clinical testing." This typically involves testing of physical samples of the device in a laboratory setting. No sample sizes for specific tests are provided, nor is information about country of origin or retrospective/prospective nature as this pertains to clinical data, which is not the focus of this submission. The tests are for engineering performance, not clinical performance based on patient data.

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)

Not applicable. This device is not an AI/ML diagnostic or prognostic device that requires expert-established ground truth from clinical cases. The "ground truth" for engineering tests is typically based on predefined specifications and standards.

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

Not applicable for this type of device and testing. Adjudication methods are relevant for subjective interpretations of clinical data, especially in AI/ML performance evaluations.

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

Not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC studies or effect size measurements for human readers with AI assistance would be performed or relevant.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for the non-clinical and bench testing is the device's conformance to established engineering specifications, industry standards (e.g., ISO for sterilization, AAMI for biocompatibility, IEC for electrical safety), and its performance being equivalent to the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device as it is not an AI/ML product.

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

Not applicable for a non-AI/ML device.

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The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed.

When used with the AcQMap 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.

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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.

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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. 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 Density/Voltage 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 of interest within the heart. Refer to 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 shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).

The information provided does not contain a typical "device performance" section with specific metrics like sensitivity, specificity, accuracy, or other quantifiable measures that would usually be compared against acceptance criteria in a table format.

This 510(k) submission primarily focuses on demonstrating substantial equivalence of a modified AcQMap 3D Imaging and Mapping Catheter (Model 900009) to a predicate AcQMap 3D Imaging and Mapping Catheter (Model 900009) (K201341). The key difference highlighted is the addition of a marker band.

Therefore, the acceptance criteria and study information largely revolve around demonstrating that this minor modification does not negatively impact safety or effectiveness, and that the original device's performance data is still applicable.

Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modified device demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate and does not raise new issues of safety or effectiveness. Explicit numerical acceptance criteria are not presented for performance in the given text.

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

• For the Modified Device (K210766):
  • No new clinical (human patient) test set was described. The submission relies on nonclinical (bench) testing primarily because the modification (marker band) is considered minor and does not affect the core functionality.
  • For nonclinical testing, specific sample sizes are not provided for each test but are implied to be sufficient for design verification and validation (e.g., "all necessary bench testing was conducted").
• For the Original AcQMap Catheter (K170819), referenced for clinical data:
  • Test Set 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 Qualifications of those Experts

• For the Modified Device (K210766): Not applicable, as no new clinical study requiring expert ground truth establishment for patient data was performed. Nonclinical testing relies on engineering and scientific evaluation.
• For the Original AcQMap Catheter (K170819) clinical study: The text does not specify the number of experts or their qualifications for establishing ground truth in the "DDRAMATIC-SVT" study. It was a clinical study involving patients with "complex arrhythmias," implying diagnosis and assessment by medical professionals, but details are not provided.

4. Adjudication Method for the Test Set

• For the Modified Device (K210766): Not applicable for clinical data. For nonclinical tests, adjudication methods are typically internal quality control and verification processes, but no specific multi-reviewer adjudication method is described.
• For the Original AcQMap Catheter (K170819) clinical study: The text does not specify any adjudication method used in the "DDRAMATIC-SVT" study.

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

• No MRMC comparative effectiveness study is described. The device is a diagnostic and mapping catheter, not explicitly an AI-assisted interpretation tool in the context of MRMC studies typical for image analysis. The "AI" component is not referenced in this document.

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

• The document describes a medical device (catheter) that collects data for visualization and recording electrical impulses. It is used with the AcQMap High Resolution Imaging and Mapping System. The performance described relates to the catheter's ability to acquire accurate data for mapping and imaging. It is not an "algorithm-only" performance study in the sense of a standalone AI diagnostic tool. Its function is to provide inputs for human interpretation and system processing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the Modified Device (K210766): For nonclinical testing, the "ground truth" would be established engineering specifications, validated test methods, and industry standards.
• For the Original AcQMap Catheter (K170819) clinical study: The study "DDRAMATIC-SVT" assessed "safety and effectiveness for its intended use" in patients with complex arrhythmias. This implies that clinical outcomes, diagnostic accuracy in identifying arrhythmias, and safety endpoints defined in the study protocol would form the "ground truth" or primary endpoints. Specific details are not provided.

8. The Sample Size for the Training Set

• The provided document describes a device (catheter) and references a clinical study for its safety and effectiveness. It does not mention any "training set" in the context of machine learning or AI algorithm development. The device's functionality is based on its physical design, sensors, and the underlying system's processing capabilities, not typically on a machine learning training dataset.

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

• Not applicable, as no training set for a machine learning algorithm is discussed in this document.

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The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

The AcQGuide® VUE deflection facilitates catheter positioning.

The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

The AcQGuide® VUE Steerable Sheath, Model 900201 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. There is a cable exiting from the handle of the sheath to provide connection for the distal electrodes. This cable terminates with four standard 2mm pins that are connected to the Auxiliary Interface Box or Auxiliary Catheter Cable of the AcQMap High Resolution Imaging and Mapping System, Model 900100 or 900000. The pin connections are assigned by the user for electrode identification (D1, 2, 3, 4) to the corresponding channel on the AcQMap System 900100. No designated order of pin connection is required. The AcQGuide® VUE Steerable Sheath includes a valve bypass tool as an optional accessory to facilitate the insertion of a loop or circular catheter.

The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.

Some of the key design attributes of the Steerable Sheath include:

• Deflectability
• Hemostasis
• Kink-resistance
• Visibility under fluoroscopy
• Easily flushed during the procedure
• Single-handed operation
• Biocompatible materials
• Sterile, single use
• Combined three-way stopcock

The AcQGuide® VUE Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. Its deflection facilitates catheter positioning, and its electrodes aid in visualization with a compatible localization system like the AcQMap System.

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

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

Based on the provided information, the acceptance criteria are largely implied by successful completion of various nonclinical tests, demonstrating the device's conformance to specifications and comparable safety and effectiveness to the predicate device.

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

The document primarily describes nonclinical (bench) testing. For these tests, specific sample sizes are not explicitly provided in the summary. The studies are prospective in nature, as they involve testing newly manufactured devices to verify their performance against established specifications. The data provenance is Acutus Medical, Inc., Carlsbad, CA, U.S.A., implying the testing was conducted or overseen by the company.

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 mention the use of experts to establish a "ground truth" for the nonclinical test sets in the way it would for a clinical study with image interpretation or disease diagnosis. The "truth" for these bench tests is derived from engineering specifications, industry standards (e.g., ISO, IEC), and established medical device testing protocols. The "physician simulated use in an animal model" likely involved qualified medical professionals, but their specific number, qualifications, and their role in establishing a "ground truth" (beyond observing performance) are not detailed.

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

No adjudication method is mentioned. For the nonclinical bench tests described, the outcomes are objective and based on meeting predefined specifications, rather than subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted or mentioned. The device described is a steerable sheath with electrodes for visualization, not an AI-powered diagnostic tool for human readers.

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

This refers to a medical device's performance without direct human intervention, especially applicable to AI algorithms. The AcQGuide® VUE Steerable Sheath is a physical medical device that inherently requires human-in-the-loop operation by a physician. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated in relation to its mechanical, electrical, and material properties, and its interaction with a compatible localization system.

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

For the nonclinical testing described, the "ground truth" is defined by:

• Engineering Specifications: For dimensional, mechanical, and functional tests.
• International Standards: Such as ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR28 for sterilization, and IEC 60601-1/1-2 for electrical safety and EMC.
• Predefined Performance Metrics: For tests like leak testing, torque, and compatibility.
• Physiological Response: In the animal model for physician simulated use.

8. The sample size for the training set

This question is not applicable. The AcQGuide® VUE Steerable Sheath is a physical medical device, not a software algorithm that requires a training set in the context of machine learning or artificial intelligence.

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

This question is not applicable, as there is no "training set" for this physical device.

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The AcQCross™ Qx Integrated Transseptal Dilator/Needle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device. AcQCross™ Qx consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Ox is fitted with a hollow stainless steel transseptal needle. Both the shaft and needle are connected to the proximal handle of AcQCross™ Qx. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a spring-tensioned actuator in the handle of AcQCross™ Ox that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. AcQCross™ Qx is for single-use only and is provided sterile.

This document is an FDA 510(k) premarket notification for a medical device called the AcQCross™ Qx Integrated Transseptal Dilator/Needle. It's a submission seeking clearance for new models of an existing device, asserting substantial equivalence to a previously cleared predicate device (K210685).

Based on the provided information, the request is to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria." However, it's crucial to understand that this document describes a submission for a device (a physical medical tool), not a PREDICATE AI/ML device or a study proving AI/ML model performance in the context of typical AI acceptance criteria (e.g., sensitivity, specificity, AUC).

Therefore, I cannot directly extract "acceptance criteria" and "study results" in the way one would for an AI/ML diagnostic or predictive model, nor can I fill out the table with metrics like sensitivity, specificity, accuracy, etc. The "performance data" section of this document refers to bench testing of a physical medical device.

I will interpret the request within the context of the provided document, focusing on the device's functional performance and the evidence provided to the FDA for its substantial equivalence, which is how "acceptance criteria" and "study proving it meets criteria" are addressed for this type of medical device.

Acceptance Criteria and Study for the AcQCross™ Qx Integrated Transseptal Dilator/Needle (K220047)

The document describes the acceptance criteria and supporting studies in terms of substantial equivalence to a predicate device (AcQCross™ Qx, K210685). The "acceptance criteria" are implicitly met if the new models perform "as intended" and present "no unacceptable risks" compared to the predicate, with specific focus on dimensional modifications facilitating compatibility with different transseptal sheaths. The "study that proves the device meets the acceptance criteria" refers to bench testing and leveraging existing data from the predicate device.

1. Table of Acceptance Criteria (Functional Performance) and Reported Device Performance

For this physical medical device, "acceptance criteria" are related to its mechanical and electrical function, material compatibility, and sterile presentation, demonstrating it functions similarly to the predicate device despite minor dimensional changes. The "reported device performance" refers to the successful completion of these tests.

• Shaft to handle tensile
• Length compatibility
• Snap engagement
• Kink resistance
• Needle actuation
• Visual inspection
• Aspiration/flushing
• Electrical continuity
  (Other tests leveraged from predicate: Dimensional Verification, Surface Inspection, Tip Curve Retention, System Leak- Air Leakage- Luer Fitting, Needle to Button Tensile, Luer to Hypotube Tensile, Pushability/Trackability, Corrosion Resistance, Radiopacity). The nonclinical bench data support the safety of the device and demonstrate that it performs as intended. |

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

• Test Set: The document does not specify exact sample sizes for each bench test (e.g., number of devices tested for tensile strength, kink resistance, etc.). However, it indicates these tests were performed on "AcQCross™ Ox" (the new models) focusing on the dimensional modifications.
• Data Provenance: The studies are bench testing conducted by the manufacturer (Acutus Medical, Inc.). This is not "data" in the sense of patient data (retrospective/prospective, country of origin). It's engineering and performance testing of the physical product.

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

This question is not applicable in the context of this device. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for diagnostic AI/ML devices. For a physical medical device like a transseptal dilator/needle, the "truth" is determined by engineering specifications and objective bench test results, often against recognized standards (e.g., ISO standards). No human expert "labels" or "interprets" a performance test in this manner.

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

This question is not applicable. Adjudication methods (concensus among multiple readers) are relevant for clinical studies, particularly in diagnostic imaging. For bench testing of a physical device, results are typically quantitative measurements and characterizations against pre-defined engineering limits or established standards.

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:

This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. This submission is for a physical, interventional medical device, not an AI/ML diagnostic tool. There is no "human-in-the-loop" performance improvement measured.

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

This question is not applicable. This refers to an AI algorithm's independent performance. The AcQCross™ Qx is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance testing is based on engineering specifications, direct measurements, and compliance with recognized industry standards (e.g., ISO 11070:2014, ISO 10555-1:2013 for general requirements, AAMI/ANSI/ISO 10993-1:2009 for biocompatibility, ISO 11135:2014 for sterilization, ANSI/AAMI IEC 60601 series for electrical safety/EMC). For example, a "kink resistance" test's ground truth would be whether the device meets a pre-defined maximum kink angle or maintains patency under a certain force, rather than an expert opinion.

8. The sample size for the training set:

This question is not applicable. This device does not use an "AI training set." Its design is based on engineering principles and knowledge gained from the predicate device, not machine learning.

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

This question is not applicable as there is no AI training set.

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

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

AND

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

OR

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

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

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

The AcQMap System hardware consists of three functional subsystems:

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

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

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

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

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

The modifications to the AcQMap System, Model 900100 includes 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.

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

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

AND

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

OR

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

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

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

The AcQMap System hardware consists of three functional subsystems:

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

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

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

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

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

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

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

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

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

1. Table of acceptance criteria and the reported device performance

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

The "acceptance criteria" here are implicitly focused on:

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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