FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

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.

Device Description

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.

SuperMap is an adjunct mapping mode to the standard, single position non-contact mapping that makes use of a timing reference (i.e. regular, stable signals from a CS catheter) to time-align measurements from multiple positions throughout the chamber (similar to the manner in which signals are time-aligned when contact mapping).

SuperMap slightly modifies the current workflow for regular rhythms by allowing the user to efficiently collect significantly more electrical data by roving (AKA "hovering") the AcQMap Catheter throughout the chamber and aligning the electrical data from multiple positions to a timing reference.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AcQMap High Resolution Imaging and Mapping System, Model 900100, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. However, it states that "the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 was tested to verify that the device meets the established performance specifications." and "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."

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AcQMap High Resolution Imaging and Mapping System, Model 900100 (K191392)) by showing that the modified device's performance is either identical or does not raise different questions of safety or effectiveness. Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence.

Here's an interpretation based on the "Comparison of Technological Characteristics" tables (Table 1, Table 2, Table 3), where "Identical" implies meeting the same performance as the predicate.

Characteristic	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Subject Device)
System Safety Standards Compliance	Adherence to IEC 60601-1:2005 /A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/A1:2013, IEC 60601-2-25:2015, IEC 60601-2-37:2015	Subject device complies with all listed IEC standards.
Ultrasound Output (Frequency)	10 MHz +/- 400 kHz	10 MHz +/- 400 kHz
Ultrasound Output (Maximum Voltage)	50V p-p	50V p-p
Ultrasound Output (Maximum Power)	1 W peak	1 W peak
Ultrasound Performance (Operating Mode)	Single operating mode	Single operating mode
Ultrasound Performance (Thermal Index)	Less than 1.0	Less than 1.0
Ultrasound Performance (Mechanical Index)	Less than 1.0	Less than 1.0
Localization Output (Frequency)	Variable 30 kHz to 60 kHz (from predicate; subject device lists Variable 15 kHz to 50 kHz for current model, but rationale states "Identical" - implying equivalence in safety/effectiveness)	Variable 15 kHz to 50 kHz (The document states "Identical" in the rationale for substantial equivalence despite the numerical difference, suggesting the change does not impact safety/effectiveness. For this table, I'm listing what is reported in the subject device column.)
Localization Output (Maximum Current)	2.2mA/cm² (from predicate; subject device lists 1.2mA RMS for current model, but rationale states "Identical")	1.2mA RMS (The document states "Identical" in the rationale for substantial equivalence despite the numerical difference, suggesting the change does not impact safety/effectiveness. For this table, I'm listing what is reported in the subject device column.)
ECG & EGM Input (Bandwidth)	0.1 Hz to 500 Hz (from predicate; subject device lists 0.05 Hz to 500 Hz for current model, but rationale states "Identical")	0.05 Hz to 500 Hz (The document states "Identical" in the rationale for substantial equivalence despite the numerical difference, suggesting the change does not impact safety/effectiveness. For this table, I'm listing what is reported in the subject device column.)
ECG & EGM Input (Resolution)	+/-10uV (from predicate; subject device lists +/-1uV for current model, but rationale states "Identical")	+/-1uV (The document states "Identical" in the rationale for substantial equivalence despite the numerical difference, suggesting the change does not impact safety/effectiveness. For this table, I'm listing what is reported in the subject device column.)
ECG & EGM Input (Timing Accuracy)	+/-1.6 microsecond	+/-1.6 microsecond
Overall Performance	Demonstrates that there are no different questions of safety or effectiveness compared to the predicate device. "Performs as intended" and "meets established performance specifications."	"Complete performance testing conducted by Acutus demonstrates that the AcQMap System performs as intended and that there are no different questions of safety or effectiveness." and "The collective results... demonstrate that the modified AcQMap System... meets its established performance specifications necessary for performance during its intended use."

Important Note on "Identical" Rationale: The document states "Identical" for several parameters where the numerical values presented for the subject and predicate device are different (e.g., Localization Output, ECG & EGM Input). This indicates that the manufacturer argues these differences are not significant enough to raise new questions of safety or effectiveness, thus maintaining substantial equivalence. For the purpose of this table, I've listed the reported performance for each device, while acknowledging the "Identical" rationale given.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Nonclinical Testing: Not explicitly stated as a single "test set" sample size. Various bench tests were performed:
  - Software Verification and Validation
  - SuperMap Mapping Validation Testing Animal Study (specific number of animals not provided in this excerpt)
  - Clinical Simulation (Reliability)
  - Map Accuracy Testing
- Clinical Testing: The clinical study for the original AcQMap System (K170948), which is referenced for the modified device, involved 84 patients.
Data Provenance:
- Nonclinical Testing: Performed by Acutus Medical, Inc. (device manufacturer).
- Clinical Testing (for referenced original device): Conducted at eight clinical sites outside the U.S.
- Retrospective or Prospective: The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the nonclinical (animal) studies or the clinical (human) study.

4. Adjudication Method (for the test set)

The document does not specify an adjudication method for either the nonclinical or clinical test sets. Given it was an "open-label" clinical study, a blinded adjudication method is unlikely to have been the primary approach.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
The device described is an "AcQMap High Resolution Imaging and Mapping System" which is a diagnostic recording system for electrophysiology procedures, capable of imaging, navigation, and mapping. While it uses "charge density-based or voltage-based maps of complex arrhythmias," it's not positioned as an AI-assisted diagnostic tool that helps human readers interpret images or data, but rather as a system that generates its own electrical maps and anatomical reconstructions. The "SuperMap" feature is an adjunct mapping mode that optimizes data collection.
Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not directly apply as a study objective or outcome discussed in this document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes the "AcQMap System" as a standalone diagnostic recording system that performs imaging, navigation, and mapping, and generates 3-D cardiac chamber reconstructions and electrical maps. The "SuperMap" feature is also inherent to the system's mapping capabilities.
The nonclinical tests like "Software Verification and Validation," "SuperMap Mapping Validation Testing Animal Study," and "Map Accuracy Testing" would implicitly involve evaluation of the algorithm's performance in generating these outputs without direct human intervention in the mapping process itself, though human clinicians operate the system and interpret its results.
So, while not explicitly called a "standalone study" in the context of an AI algorithm, the system's core mapping and reconstruction functions operate algorithmically.

7. The Type of Ground Truth Used

Nonclinical (Animal Study): Not explicitly stated, but for "SuperMap Mapping Validation Testing" and "Accuracy Validation Testing," ground truth would likely involve direct physiological measurements, known anatomical structures, and perhaps comparison to established gold standard mapping techniques within the animal model.
Clinical Study (DDRAMATIC-SVT for original device): Not explicitly stated. For "Assessing Therapy In Complex Supraventricular Tachycardia," ground truth for efficacy would typically involve successful treatment outcomes, cessation of arrhythmia, or correlation with conventional electrophysiological measurements. Safety would be evaluated based on adverse event rates.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" sample size. This is a 510(k) submission for a medical device that appears to be based on established biophysical principles and signal processing, rather than a deep learning AI model that requires large labeled training datasets in the typical sense. The term "Software Verification and Validation" suggests traditional software engineering practices were applied.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or detailed in the context of AI/machine learning, this information is not provided in the document. The referenced clinical and nonclinical studies serve as validation for the device's performance, not as sources for a training set.

Summary

Regulation Number and Section

§ 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).