Search Results

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.

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