(84 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 High Resolution Imaging System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber and displaying electrical impulses as either charge density-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 High Resolution Imaging 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 High Resolution Imaging and Mapping 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 (hereafter referred to as the AcQMap System) operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The 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 of the atrial chambers of the heart.
The AcQMap System hardware consists of three (3) functional subsystems:
- . Ultrasound imaging,
- ECG and EGM recording; and
- Impedance based electrode Localization.
The AcQMap System is used in conjunction with the AcQMap 3D Imaging and Mapping Catheter (hereafter referred to as the AcQMap Catheter). The AcQMap System provides:
- . 3-D cardiac chamber reconstruction – Contact and non-contact (ultrasound),
- 3-D 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 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.
In addition, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one (1) 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.
There are no modifications to the hardware of the AcQMap System nor its accessories. The modifications to the AcQMap System are specific to the software, which include:
- The addition of the feature, Dynamic Referencing. Dynamic Referencing actively monitors impedance-based stability events like catheter drift or shift. Users will be offered guided notifications when shifts or drifts are automatically detected. Dynamic Referencing combines the capabilities of a Virtual Position Reference (VPR) and a Physical Position Reference (PPR), allowing them to be used together simultaneously. It is designed to be used instead of VPR or PPR alone. VPR and PPR remain available as options and
- Updated elements of the user interface to make it easier for the user to conduct a variety of actions within the software.
The provided text focuses on the substantial equivalence of the AcQMap High Resolution Imaging and Mapping System (K231091) to its predicate device (K222209), with an emphasis on changes to software and user interface. It states that "no further clinical testing is required" for the subject device and refers to clinical testing performed for the original AcQMap System (K170948).
Therefore, the acceptance criteria and study information will be derived from the description of the original AcQMap System's clinical study (DDRAMATIC-SVT) referenced in the document.
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 explicitly state quantitative "acceptance criteria" and "reported device performance" in a table format for the subject device (K231091) or for the original device (K170948) from its clinical study. Instead, it makes a general statement that the results of the DDRAMATIC-SVT study "demonstrated that the AcQMap System is substantially equivalent to the predicate device."
For the subject device (K231091), the modifications are described as improving "ease-of-use of some system capabilities" and having "no changes to the current mapping data." The conclusion is that "the subject device meets its established performance specifications necessary for performance during its intended use."
Without specific metrics or thresholds, a direct table of acceptance criteria and performance cannot be created from this text.
2. Sample size used for the test set and the data provenance
- Sample Size: 84 patients
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight (8) 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
The document does not specify the number of experts or their qualifications for establishing the ground truth in the DDRAMATIC-SVT study. It only mentions that the system displays electrical impulses and maps for physicians to "identify the source(s) of the arrhythmia."
4. Adjudication method for the test set
The document does not mention any 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
The document describes the clinical study (DDRAMATIC-SVT) as a non-randomized, open-label study to establish substantial equivalence. It does not indicate that it was a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance, nor does it provide any effect size concerning human reader improvement. The focus is on the device's diagnostic capabilities, not on direct physician performance improvement with the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the AcQMap System as "intended to be used by physicians" to reconstruct chambers and display electrical impulses and maps to identify arrhythmia sources. This implies a human-in-the-loop performance context. The text does not mention any standalone algorithm-only performance assessment.
7. The type of ground truth used
The text describes the AcQMap System's purpose as helping physicians "identify the source(s) of the arrhythmia" using "charge density-based or voltage-based maps." This strongly suggests that the ground truth for the clinical study would be derived from electrophysiological measurements and clinical consensus regarding the arrhythmia source, but it does not explicitly state "expert consensus," "pathology," or "outcomes data." However, given the context of electrophysiology procedures, expert interpretation of electrophysiological data would be the most likely form of ground truth.
8. The sample size for the training set
The document focuses on the clinical validation study (DDRAMATIC-SVT) for the original device (K170948), which served as the test set for demonstrating substantial equivalence. It does not provide information about a separate "training set" used for developing the software features or maps of the AcQMap System.
9. How the ground truth for the training set was established
As no training set is explicitly mentioned, how its ground truth was established is not described in the provided text.
§ 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).