(228 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 (cleared under K170819). 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 AcQMap System is used with the AcQMap Patient Electrode Kit.
The provided text describes a 510(k) premarket notification for the "AcQMap High Resolution Imaging and Mapping System, Model 900100". The submission states that this is a modification to an already cleared device (K193013), specifically replacing the cleared Patient Electrode Kit with a new one (800605). Therefore, the study details predominantly refer to the clinical testing of the original AcQMap System (K170948), and the current submission includes non-clinical performance data for the modified Patient Electrode Kit.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table detailing acceptance criteria for the modified device and its performance in a quantitative manner. Instead, it states that "All testing performed met the established performance specifications" for the nonclinical tests. For the clinical study of the original device, it
states the system was "safe and effective."
Here's a summary of the non-clinical tests performed on the new Patient Electrode Kit:
| Test Type | Acceptance Criteria / Reported Performance |
|---|---|
| Performance Test | Met established performance specifications for: |
| - Gel adhesion | |
| - Electrode impedance | |
| - Wire insulation wall thickness | |
| - Lead wire pull strength | |
| - Lead wire flex life | |
| Biocompatibility Test | Demonstrated acceptability for use. |
| Shelf-Life Test | Demonstrated acceptability for use. |
| Usability Test | Demonstrated acceptability for use. |
| Non-GLP Animal Test | Demonstrated acceptability for use. |
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 clinical study of the original AcQMap System (K170948):
- Sample Size: 84 patients
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
For the nonclinical tests for the modified Patient Electrode Kit, the sample sizes are not explicitly stated, but the tests were performed as part of design verification.
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)
This information is not provided in the document. The clinical study for the original device assessed the system's "safety and effectiveness," which likely involved clinical endpoints rather than ground truth established by a panel of experts for a diagnostic algorithm in the way a reader study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A MRMC comparative effectiveness study is not mentioned in the document. The clinical study was focused on the safety and effectiveness of the AcQMap System itself, not specifically on human reader improvement with AI assistance. The AcQMap System is described as displaying electrical impulses and information about electrical activity and catheter location, which assists physicians, but the study described does not quantify physician improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The AcQMap System is described as a "diagnostic recording system" that is "intended for use in the Electrophysiology (EP) Lab" and "used by physicians." This implies human-in-the-loop performance rather than a standalone algorithm. The device displays information to assist physicians in identifying arrhythmia sources.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical study of the original AcQMap System (K170948), the study aimed to demonstrate "safety and effectiveness" for its intended use in "complex arrhythmias." This suggests the ground truth was likely clinical outcomes data related to the efficacy of the diagnostic/mapping capabilities in guiding procedures and potentially the success of therapy for supraventricular tachycardia (SVT), as the study was entitled "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)". Specific details on how ground truth was established for mapping accuracy or arrhythmia identification are not provided.
8. The sample size for the training set
The document does not specify a training set size. The submission focuses on the clinical validation of a previously cleared device (K170948) and nonclinical testing of a component modification. If machine learning was used in the development of the AcQMap System's algorithms, the data used for training is not detailed in this document.
9. How the ground truth for the training set was established
This information is not provided in the 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).