(64 days)
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.
| Characteristic/Criterion (Inferred) | Reported Device Performance (Model 900100) |
|---|---|
| Identical Indications for Use to Predicate 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." (Identical to Predicate) |
| Safety and Effectiveness Comparable to Predicate Device (No new questions of safety or effectiveness) | "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." Differences in physical characteristics (dimensions, weight, power, input current) and some functional characteristics (localization output frequency, ECG & EGM bandwidth/resolution, addition of Auxiliary Interface Box, Defibrillation-Proof features, new cables) are presented as not raising new safety or effectiveness questions, as demonstrated through performance testing. |
| Conformance to Design Specifications | "The collective results of the testing demonstrate that the design of the AcQMap® High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use." |
| Clinical Performance (based on predicate device study): Safe and Effective for Intended Use | "The results for 84 patients demonstrated that the AcQMap System is safe and effective for its intended use." (This refers to the DDRAMATIC-SVT study conducted for the original AcQMap System K170948, which is incorporated by reference.) No specific quantitative metrics like sensitivity/specificity for complex arrhythmia identification are provided in this summary. The device's function is to display electrical impulses and reconstruct chamber anatomy, which likely implies visual and measurement accuracy validated during the predicate's clinical study and confirmed through non-clinical testing for the new device. |
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.
§ 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).