(150 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 AcQTrack™ Conduction Pattern (Conduction Pattern Recognition) feature, Composite Mapping feature and Complex Fractionated Atrial Electrogram (CFAE) calculation that adds additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered.
The provided text describes a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System, Model 900100. This submission focuses on modifications to the software features of an existing device, adding "AcQTrack™ Conduction Pattern (Conduction Pattern Recognition), Composite Mapping, and Complex Fractionated Atrial Electrogram (CFAE) calculation". The core system and its existing mapping capabilities remain unchanged.
Therefore, the acceptance criteria and performance data provided relate primarily to the demonstration of substantial equivalence for these software modifications to the previously cleared predicate device (K193013), and ultimately to the original AcQMap System cleared under K170948.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the new software features in terms of specific metrics like sensitivity or specificity. Instead, the performance is demonstrated through verification and validation activities showing that the additional features function as intended and do not introduce new safety or effectiveness concerns, maintaining substantial equivalence to the predicate.
The "acceptance criteria" here are implicitly focused on:
- The new software features (AcQTrack Conduction Pattern, Composite Mapping, CFAE calculation) performing their intended post-processing and data summarization functions correctly.
- The overall system maintaining its established safety and performance characteristics, as demonstrated by the predicate device (K193013) and the original device (K170948).
- No new questions of safety or effectiveness being raised by the modifications.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| New Software Features Functionality: The AcQTrack Conduction Pattern, Composite Mapping, and CFAE calculation features provide accurate post-processing and summary data display options as intended. | These additional software display features have been "previously documented in the literature," "validated with both simulation and clinical data," and are described as "optional tools to provide a summarization of existing data to expedite the physician's interpretation of the data based on physician-established criteria." The software verification and validation activities and clinical simulation (reliability) studies were repeated for the modified device to confirm these functions. |
| Maintenance of Foundational Performance (System Accuracy): The system's ability to reconstruct cardiac chambers, display electrical impulses, and locate catheters remains accurate. | Map Accuracy Evaluation was repeated for the modified device. The remaining accuracy testing, including system accuracy testing, was incorporated by reference from the original AcQMap System 510(k) (K170948). The collective results for the modified device demonstrated it "meets the established performance specifications." |
| Safety and Electrical/Electromagnetic Compatibility: The modified device maintains safety standards and electromagnetic/electrical compatibility. | Electromagnetic and Electrical Safety testing was repeated for the modified device. The balance of testing (including Transportation Testing, AcQMap Verification Testing, Electromagnetic Compatibility and Electrical Safety Testing, System Safety Standards (IEC 60601 series)) was incorporated by reference from the original AcQMap System 510(k). The document states identical safety standards are met, and "there are no changes to hardware." |
| No New Questions of Safety or Effectiveness: The modifications do not introduce any new safety or effectiveness concerns. | "The modifications...add additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered." "The collective results of the nonclinical testing...demonstrate that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device." "The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference." The study showed the original system was substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- For the modifications (new software features): The text mentions these features were "validated with both simulation and clinical data" but does not specify the sample size or provenance for this validation specifically for the new features.
- For the original AcQMap System (K170948), which established the foundational equivalence:
- 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 the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not provide details on the number or qualifications of experts used to establish ground truth for either the validation of the new software features or the clinical study of the original AcQMap system. The new features are designed to "expedite the physician's interpretation of the data based on physician-established criteria," implying clinical expert interpretation is central, but specifics are missing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth or evaluating the test sets.
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
The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The new features are described as "optional tools to provide a summarization of existing data to expedite the physician's interpretation," suggesting an assistive role, but no formal comparative study of human performance improvement is reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly describe a standalone performance study of the new software features (AcQTrack, Composite Mapping, CFAE calculation) without human-in-the-loop. These features are presented as "additional post processing and summary data display options" to assist physician interpretation rather than operating purely standalone. The core mapping system, however, performs its functions (reconstruction, electrical mapping, localization) without direct human intervention in the data acquisition/initial processing.
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 to evaluate the new software features. For the clinical study of the original device (K170948), it refers to "electrophysiology procedures" in patients and assessing therapy, suggesting that clinical observations and outcomes from these procedures would inherently form the basis of ground truth for assessing the system's mapping and imaging capabilities. However, specific methods for establishing ground truth (e.g., expert consensus on specific arrhythmia origins) are not detailed.
8. The sample size for the training set
The document does not provide a sample size for any training set. Since the modifications are described as "additional software display features" and post-processing tools, and no new method of data gathering is mentioned, it's possible that the development of these algorithms leveraged existing clinical data previously collected for the predicate device, but this is not specified.
9. How the ground truth for the training set was established
The document does not provide information on how ground truth was established for any training set.
§ 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).