(17 days)
The Active ECG Electrodes (AECGE) are designed to allow for an optimized ECG acquisition during MR examinations. The small dimensions and the method of placing the AECGE directly above the patient's heart are means of minimizing the interference with the MR system.
The Active ECG Electrodes (AECGE) is an ECG acquisition option for the Magnetom Vision
Unfortunately, no information is provided in the document regarding acceptance criteria or a specific study that proves the device meets those criteria.
The document is a 510(k) summary and the FDA's clearance letter for the "Active ECG Electrodes MAGNETOM VISION Systems." It focuses on demonstrating substantial equivalence to a previously cleared device (Siemens Magnetom Impact, 42 SP and 63 SP with Disposable ECG Electrodes, K915112), rather than providing detailed performance data against specific acceptance criteria.
Here's a breakdown of what is and is not in the provided text, related to your request:
What is present:
- Device Description and Intended Use: The Active ECG Electrodes (AECGE) are an ECG acquisition option for the Magnetom Vision, designed for optimized ECG acquisition during MR examinations by minimizing interference.
- Technological Characteristics: States that the magnet, RF system, and gradient system are substantially equivalent to the standard MAGNETOM Vision system.
- General Safety and Effectiveness Concerns: Lists MR safety and performance parameters that are unaffected by the modification (e.g., Maximum Static Field, RF Power Deposition, Signal to Noise, Image Uniformity). This implies these parameters already meet established safety and performance levels for MRI systems, and the new electrodes do not degrade them.
- Substantial Equivalence Claim: The core of the 510(k) is the assertion that the device is substantially equivalent to a predicate device.
What is NOT present (and therefore cannot be extracted from this document):
- A table of acceptance criteria and reported device performance: This document does not present specific quantitative performance metrics for the Active ECG Electrodes, nor does it list acceptance criteria that these metrics would be measured against. The focus is on not affecting the performance of the core MR system.
- Sample sized used for the test set and data provenance: No information is given about any specific studies conducted solely on these active ECG electrodes to measure performance.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as a dedicated performance study with a test set and ground truth is not described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: No mention of such a study.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is hardware (electrodes), not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as this is hardware.
- How the ground truth for the training set was established: Not applicable.
In essence, this document is a regulatory submission demonstrating that a new component (Active ECG Electrodes) does not negatively impact the safety and effectiveness of an existing, cleared medical device (MAGNETOM VISION MR system) and thus is substantially equivalent to another existing component (Disposable ECG Electrodes). It does not provide the kind of detailed performance study and acceptance criteria often seen for new diagnostic algorithms or devices with novel performance claims.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.