(200 days)
The AcQMap® High Resolution Imaging 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.
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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 ("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 functional subsystems:
- Ultrasound imaging,
- ECG and EGM recording; and
- Impedance based electrode Localization.
The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter. The AcQMap System provides:
- 3-D cardiac chamber reconstruction imaging,
- Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
- Cardiac electrical activity as waveform traces,
- Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcQMap System is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, and a workstation. The AcQMap System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
The provided text does not contain detailed acceptance criteria and device performance results in a table format for the AcQMap High Resolution Imaging and Mapping System. However, it does outline the types of testing performed and states that the device meets its established performance specifications.
Here's a summary of the available information regarding the device's testing and acceptance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table with numerical acceptance criteria and corresponding device performance values. It broadly states that the device was tested to verify it met established performance specifications.
2. Sample Size and Data Provenance for Test Set:
- Test Set (Clinical Study):
- Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
- Test Set (Nonclinical Testing):
- The document implies extensive bench and software verification/validation testing was conducted, but does not specify sample sizes for these nonclinical tests.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number of experts used or their qualifications to establish ground truth for either the clinical or non-clinical studies.
4. Adjudication Method:
The document does not specify any adjudication method used for either the clinical or non-clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The clinical study was focused on demonstrating the safety and performance of the AcQMap System itself, not its impact on human reader performance.
6. Standalone (Algorithm Only) Performance:
The document describes the AcQMap System as a diagnostic recording system, implying that its output (e.g., 3-D cardiac chamber reconstruction, electrical maps) is intended for physician interpretation. It does not explicitly state if a standalone (algorithm-only) performance evaluation was conducted distinct from a human-in-the-loop scenario. The clinical study evaluated the system's ability to gather data and create maps for physicians, suggesting a human-in-the-loop context.
7. Type of Ground Truth Used:
- For the clinical study, the ground truth indirectly relates to the system's ability to "gather data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia." The "safety and effective for its intended use" conclusion implies that the system's outputs were considered accurate and useful in diagnosing and assessing complex arrhythmias. However, the exact method for establishing this ground truth (e.g., comparison to another gold standard, expert consensus on the generated maps) is not detailed.
- For nonclinical testing (e.g., system accuracy, software verification), the ground truth would typically be established based on engineering specifications and known physical properties, but specific details are not provided.
8. Sample Size for Training Set:
The document does not provide any information about the sample size used for a training set. This suggests that if machine learning or AI models were used, the training data details are not included in this summary.
9. How Ground Truth for Training Set Was Established:
As no training set sample size is provided, the document does not describe how ground truth for a training set was established.
Summary of Device Performance and Acceptance Criteria (as described):
The device underwent both nonclinical and clinical testing.
- Nonclinical Testing: Included transportation testing, AcQMap verification testing, software verification and validation, system accuracy testing, electromagnetic compatibility and electrical safety testing, and an AcQMap Catheter Validation Testing-Animal Study. The results "demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use." It also "does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps that display chamber-wide electrical activation when compared to the predicate devices."
- Clinical Testing: A prospective, non-randomized, open-label study (DDRAMATIC-SVT) was conducted on 84 patients outside the U.S. The study aimed to demonstrate the safety and performance of the AcQMap System in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. The results lead to the conclusion that the AcQMap System is "safe and effective for its intended use."
The device was deemed "substantially equivalent" to predicate devices (EnSite Velocity™ Cardiac Mapping System and iLab™ Ultrasound Imaging System) based on these tests, implying it met the necessary safety and performance benchmarks for its stated indications for use.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).