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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 and Mapping 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 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 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 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 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 High Resolution Imaging and Mapping System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording; and Impedance based electrode Localization. The AcQMap High Resolution Imaging and Mapping System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 (cleared under K201341). The AcQMap High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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. Additionally, the AcQMap High Resolution Imaging and Mapping 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 High Resolution Imaging System include the addition of new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and DiamondTemp™ Ablation Generator.

Below is an analysis of the provided text regarding the AcmMap High Resolution Imaging and Mapping System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission does not specify numerical acceptance criteria for the device's performance regarding imaging, mapping accuracy, or specific clinical outcomes. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (AcQMap High Resolution Imaging and Mapping System, K220784) and the original version of the system (K170948).

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly to the predicate/original device and meets established non-clinical performance specifications.

Note: The document explicitly states "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." This implies the performance is at least equivalent to the predicate.

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

• Nonclinical Testing Test Set (Modified Device): Not explicitly stated as a number of devices. The description implies testing was conducted on "the modified AcQMap High Resolution Imaging and Mapping System" to verify specifications. It's likely one or a few units were tested for each specific bench test (e.g., RF attenuation, waveform fidelity).
• Clinical Testing Test Set (Original Device, K170948, incorporated by reference): "84 patients".
• Data Provenance (Clinical Study): "prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S." This indicates the data is prospective and from international sites.

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

The provided document does not specify the number or qualifications of experts for establishing ground truth.

• For the nonclinical bench testing, "ground truth" would be engineering specifications and measurements.
• For the clinical study (DDRAMATIC-SVT), it's a study on "Assesment of Therapy In Complex Supraventricular Tachycardia," suggesting clinical outcomes and electrophysiological assessments would be the standard. The direct role of external experts in establishing "ground truth" as a separate process from the study conduct itself is not detailed. Standard clinical trials rely on physician diagnoses and assessments, but the specific process for ground truth establishment by an independent panel is not mentioned.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, either for nonclinical testing or for the clinical study incorporated by reference. Clinical trials usually involve endpoint adjudication, but the details are not included here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned. The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study designed to assess the performance of the original AcQMap System (K170948) and demonstrate its substantial equivalence. It does not appear to be a study comparing human readers with and without AI assistance to measure an effect size.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The document primarily focuses on the system as a diagnostic recording system, capable of imaging, navigation, and mapping for use by physicians to identify sources of arrhythmia. The outputs (3-D reconstructions, electrical maps, catheter positions, waveforms) are intended to assist physicians.

While there are "System Accuracy Testing" and "Map Accuracy Evaluation" as part of the non-clinical testing, these likely assess the technical accuracy of the algorithms in generating mapping data against defined inputs, rather than an "algorithm only" clinical performance study in the sense of making diagnostic decisions without human interpretation. The system is designed to provide information to the clinician, not to make a standalone diagnosis.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Nonclinical Testing: Engineering specifications, physical measurements, and established safety standards (IEC 60601-1, IEC 60601-1-2, IEC 62366-1, etc.) would serve as ground truth for these tests.
• Clinical Study (DDRAMATIC-SVT): The study title "Assessment of Therapy In Complex Supraventricular Tachycardia" suggests the ground truth would involve clinical outcomes related to the diagnosis and treatment of arrhythmias, likely including electrophysiological assessments and patient responses to therapy. The specifics of how "ground truth" was established (e.g., confirmed arrhythmia diagnosis by an independent panel, successful ablation outcomes) are not detailed in this excerpt.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The device is described as "Programable diagnostic computer and Ultrasonic pulsed echo imaging system," but the application is for a modification to an existing system (adding connectivity accessories). The previous versions of the system (K220784 predicate and K170948 original) would have undergone validation, but whether a machine learning model with a distinct "training set" was used for the core mapping functionalities is not specified in this document. Given the nature of previous predicate devices for mapping systems, it's less likely to be a deep learning model requiring a large training set in the modern AI sense, and more likely based on signal processing and physics-based reconstruction algorithms.

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

Since no explicit training set is mentioned for an AI/ML component, the method for establishing its ground truth is not described. For traditional signal processing and reconstruction algorithms, "ground truth" during development often comes from simulated data, phantom studies, and expert-validated real-world data used for algorithm design and initial tuning. These details are not in the provided document.

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The AcQCross™ Qx Integrated Transseptal DilatorNeedle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). AcQCross™ Ox consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Qx is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of AcQCross™ QX. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a spring-tensioned actuator in the handle of AcQCross™ QX that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. AcQCross™ Qx is for single-use only and is provided sterile.

This document is a 510(k) summary for the AcQCross™ Qx Integrated Transseptal Dilator/Needle, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated as this type of information is generally not included in a 510(k) summary that relies on demonstrating equivalence to a previously cleared device.

However, I can extract the relevant information regarding performance testing and how substantial equivalence was established.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for the device performance tests. Instead, it relies on demonstrating that the AcQCross™ Qx performs "as intended" and that "minor differences do not potentially impact the safety and effectiveness" compared to the predicate device. The performance tests were conducted in accordance with ISO standards and additional bench testing was performed on the modified standalone device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document is a 510(k) summary for a medical device that relies on substantial equivalence. It does not contain information about the sample sizes used for the performance tests. The data provenance (country of origin, retrospective/prospective) is also not specified, which is typical for this type of regulatory submission focusing on engineering and bench testing.

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 applicable to the type of testing described in this document. The performance tests are engineering-based (biocompatibility, sterilization, electrical safety, bench testing) and do not involve "ground truth" derived from expert medical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the case for the engineering performance tests described.

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

This information is not applicable. The device (transseptal dilator/needle) is a mechanical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.

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

This information is not applicable as the device is a physical medical instrument, not an algorithm. The phrase "standalone device" in the document refers to the AcQCross™ Qx being cleared for use by itself (with compatible sheaths) rather than only as part of specific introducer sets.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground truth, in the context of clinical or diagnostic studies, is not applicable here. The "truth" for the performance tests (e.g., biocompatibility showing no toxicity, sterilization achieving SAL, mechanical forces meeting specifications) is established through standardized laboratory testing and engineering validation.

8. The sample size for the training set

This information is not applicable. The device is a mechanical tool; it does not involve training data sets or machine learning algorithms.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of medical device.

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