(30 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 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.
§ 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).