(237 days)
The AcQMap® High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either dipole density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
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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 System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation, the AcQMap Patient Interface Unit, and the AcQMap Ablation Interface Unit.
The AcQMap® High Resolution Imaging and Mapping System ("AcQMap System") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping the atrial chambers of the heart.
The AcQMap System hardware consists of three functional subsystems:
- Ultrasound imaging.
- ECG and EGM recording; and
- Impedance based electrode Localization.
The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter. The AcQMap System provides:
- 3-D cardiac chamber reconstruction imaging,
- Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
- Cardiac electrical activity as waveform traces,
- Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density-based maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcQMap System is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, and a workstation. The AcQMap System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
The provided document is a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System. This submission aims to clear an updated version of an already cleared device (K170948) with new software features (Anatomic Reference, Markers Enhancement, and Graphical User Interface Refresh). The core device and its indications for use remain identical to the predicate device.
Given that this is a 510(k) for an updated version of a previously cleared device with new software features, the acceptance criteria and performance data provided focus on demonstrating that these new features do not raise new questions of safety or effectiveness and that the overall system continues to meet its established performance specifications. The document mainly highlights that the indications for use, technological characteristics (beyond the software updates), and safety standards are identical to the predicate device. Therefore, the "acceptance criteria" discussed are largely based on the established safety and performance of the predicate device, supplemented by testing of the new software features.
Here's an attempt to extract and synthesize the requested information, acknowledging the limitations inherent in this type of FDA document (which summarizes testing rather than providing detailed study protocols or results):
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that the device was tested to "ensure that it conforms to the design specifications" and that the "results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use."
The updated software features (Anatomic Reference, Markers Enhancement, Graphical User Interface Refresh) are evaluated to ensure they do not alter the fundamental safety or effectiveness. The core "acceptance criteria" are implied to be the successful demonstration that the device (with these updates) continues to meet safety and performance standards equivalent to the predicate device.
Implied Acceptance Criteria and Performance Summary:
| Feature/Aspect | Acceptance Criteria (Implied) | Reported Device Performance (Summary from document) |
|---|---|---|
| New Software Features: Anatomic Reference, Markers Enhancement, Graphical User Interface Refresh | Do not raise any different questions of safety or effectiveness compared to the predicate device; function as intended without compromising existing device performance. | "Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness." The new features are integrated, and the system continues to demonstrate safety and effectiveness for its intended use. "The collective results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use." |
| Overall System Performance (Bench/Nonclinical) | Conformance to design specifications; meeting established performance specifications for imaging, navigation, and mapping; adherence to safety standards (e.g., IEC 60601 series). No new safety or effectiveness concerns compared to the predicate. | "The necessary bench testing was performed on the AcQMap System to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device." "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap System meet the established specifications necessary for consistent performance during its intended use." |
| Clinical Safety and Effectiveness | Safe and effective for its intended use (reconstructing cardiac chambers, visualizing anatomy, displaying electrical impulses as dipole density-based or voltage-based maps of complex arrhythmias, and displaying catheter positions). | A clinical study (DDRAMATIC-SVT) "demonstrate[d] that the AcQMap System is safe and effective for its intended use" in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. (The specific countries are not mentioned).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth in the clinical study, nor does it detail their qualifications. The study focused on the device's ability to "gather data to create right and/or left atrial dipole density activation maps," implying that the "ground truth" might be related to the device's own generated maps and system performance metrics rather than a direct comparison to an external expert-adjudicated "true" diagnosis or condition, especially since it's a diagnostic mapping system.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the clinical test set data from the DDRAMATIC-SVT study. Given it's a diagnostic system, adjudication would typically involve expert interpretation of the generated maps, but this detail is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study is not explicitly mentioned. The study "DDRAMATIC-SVT" was a single-arm study to demonstrate the device's safety and performance, not a comparison against human readers or other systems. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the bench and non-clinical testing sections imply standalone performance evaluation.
- "System Accuracy Testing"
- "AcQMap Verification Testing"
- "Software Verification and Validation"
- "Electromagnetic Compatibility and Electrical Safety Testing"
These tests evaluate the device's intrinsic performance characteristics without direct human-in-the-loop diagnostic interpretation in the context of a clinical decision. The clinical study, while involving human operators, still assesses the system's ability to generate data and maps as intended. The "algorithm" for generating the maps is part of the "system" being tested.
7. The Type of Ground Truth Used
For the clinical study: The "ground truth" seems to be intrinsic to the device's function – its ability to "gather data to create right and/or left atrial dipole density activation maps." The study assessed whether the system could effectively perform this function and whether it was safe. It's essentially using the device's own output as its "performance metric" against its design intent, rather than comparing it to an independent, external gold standard like pathology or long-term outcomes to validate diagnostic accuracy.
For bench and non-clinical testing: The ground truth would be based on engineering specifications, established test methods, and potentially simulated data or measurements from phantoms.
8. The Sample Size for the Training Set
The document does not provide details about a "training set" or "validation set" in the context of an AI/ML algorithm being developed. The AcQMap System is described as a "diagnostic recording system" and "computer-based system," but the documentation focuses on its substantial equivalence to a predicate device and verification/validation testing of its software features rather than an AI development paradigm.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" for an AI/ML algorithm is not explicitly mentioned, the method for establishing its ground truth is not provided. The development process described aligns more with traditional software verification and validation where specifications define the expected behavior.
§ 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).