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The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures.

The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Device Description

The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.

The EP-TRACER is comprised of these major components:
EP-TRACER hardware – Amplifier/stimulator
EP-TRACER Software – Software pre-installed

AI/ML Overview

This document describes the EP-TRACER System V2.2, an electrophysiology measurement system. The FDA 510(k) clearance (K183266) states its substantial equivalence to the predicate device, EP-TRACER System V2.0 (K161245). This submission primarily focuses on software modifications affecting the user interface, with no changes to the hardware.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative, measurable format like sensitivity/specificity thresholds for a diagnostic device. Instead, the "acceptance criteria" for this submission are implicitly defined by demonstrating that the modifications to the device (V2.2 compared to V2.0) do not adversely affect safety and effectiveness and that the device conforms to relevant harmonized standards.

The "device performance" is therefore described by showing that the new device (V2.2) maintains the same fundamental technological characteristics and meets all applicable standards as the predicate device (V2.0).

Characteristic / Acceptance Criteria Type	Predicate Device EP-TRACER V2.0 Performance (Implicit Acceptance Baseline)	New Device EP-TRACER V2.2 Performance (Reported)	Met?
Hardware Components	Same as listed in "Technological Characteristics" table	Same	Yes
Amplifier Dimensions	38 channels: 28x27x7 cm; 70/102 channels: 28x27x12 cm	Same	Yes
Environmental Specs (Temp, Humidity)	Operating: +10°C to +30°C, 20-80% rH; Storage: -29°C to +66°C, <95% rH	Same	Yes
Power Specs (Input, Requirements)	100-240 V AC, 50-60 Hz; specific V/A for channels	Same	Yes
Design (Sampling Rate, CMRR, Impedance, Leakage, Filters, Gain, Dynamic Range, Baseline Correct.)	1 kHz, >100 dB, 20 MΩ, <10 μA patient, <100 μA chassis, various filters, etc.	Same	Yes
Stimulator Specs (Pulse Amplitude/Duration, ISI, etc.)	Specific ranges and accuracies as listed in table	Same	Yes
Pacing Channels (Isolated, Isolation)	2 isolated channels, IEC 60601-1 compliant	Same	Yes
Computer Controlled Stimulus Pulses	Ranges and accuracies for current, pulse duration, load impedance, etc.	Same	Yes
Programmed Protocols	BASIC 1, 2, 3; ACUTE, Multi-Sx, Pace, etc.	Same	Yes
Programmed Protocol Key	10	Same	Yes
Number of Extra-Stimuli	5 (S2 - S6)	Same	Yes
Sensing (ECG Sync)	Internal from surface/intracardiac, trigger lockup, ECG delay	Same	Yes
Backup Stimulation	Use external backup stimulator	Same	Yes
Compliance with Standards	EN ISO 13485:2012, EN ISO 14971:2012, EN 60601-x series, EN 10993-1, etc.	Conformance demonstrated	Yes
Software User Interface (New)
Pressure mode display	Full-screen only	Full-screen and "minimized" display	N/A
Calipers	Horizontal only	Horizontal and vertical	N/A
Eport Generation	Limited format transfer	Customizable, preconfigured template transfer	N/A
Clock	Real-time clock	Real-time clock + procedure clock	N/A
New Icons	No (keystrokes for these functions)	Yes (for split-screens, pressure mode, stimulator settings, add comment/mark, screenshot, toggle stimulator windows)	N/A
Software Compatibility	Windows 7 (32 bit)	Windows 7 (64 bit) and (32 bit)	N/A
Overall Safety and Effectiveness	No adverse effects from modifications due to V&V activities.	Yes	Yes

N/A for "Met?" column for new software features as they are additions/improvements, not criteria to be met against a baseline.

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

The document does not describe a clinical study with patients or data from a test set in the traditional sense of evaluating diagnostic accuracy. This submission is for an electrophysiology measurement system, with the current iteration (V2.2) involving only software modifications to the user interface. The performance testing primarily focused on demonstrating conformity to harmonized standards and verifying that the software changes did not negatively impact the device's safety and effectiveness.

Therefore, there is no specific mention of a "test set" sample size or data provenance (country of origin, retrospective/prospective) related to patient data or clinical outcomes. The evaluation is based on engineering verification and validation activities against the pre-existing design specifications and regulatory standards.

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

Given that this is a modification to an electrophysiology measurement system focusing on user interface changes and compliance with standards, there is no indication of "experts" being used to establish ground truth for a test set in a diagnostic or clinical performance context. The "ground truth" here would relate to the correct functioning of the system's electrical measurements and stimulation based on engineering specifications and adherence to standards, likely assessed by qualified engineers and domain experts internal to the manufacturer.

4. Adjudication Method for the Test Set

As there is no described "test set" involving human interpretation or clinical data requiring ground truth establishment, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was mentioned or performed. This device is an electrophysiology measurement system, not an AI-assisted diagnostic tool for image interpretation or similar. The "user interface convenience features" are productivity enhancements rather than AI-driven diagnostic assistance.

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

This is not applicable. The EP-TRACER System is an electrophysiology measurement system used by human operators (clinicians) for acquiring, displaying, and recording signals and performing diagnostic cardiac stimulation. It is not an algorithm designed to perform a standalone diagnostic task without human intervention. The software updates are improvements to the human-machine interface.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this submission, the "ground truth" essentially refers to:

The engineering specifications of the device (e.g., accuracy of pulse amplitude, sampling rate, filter characteristics).
Compliance with harmonized standards (e.g., electrical safety, EMC, usability).
The predicate device (EP-TRACER V2.0) as a baseline for safety and effectiveness of the core functionality.

The performance testing (verification and validation) demonstrated that the updated software met predetermined design and performance specifications and that modifications did not adversely affect the safety and effectiveness compared to the predicate.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of machine learning or AI, as this submission doesn't describe an AI/ML algorithm being developed or deployed. The software modifications are user interface improvements.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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