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510(k) Data Aggregation
(66 days)
ENDO-ESOPHAGEAL MR COIL
The Surgi-Vision Endo-Esophageal MRI Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophagus. The one-time use, disposable Endo-Esophageal MRI Coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.
The Surgi-Vision Endo-Esophageal MRI Coil is a specialty coil for use in MRI imaging of the anatomical regions surrounding the esophagus. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for GE MRI systems. The coil and cable are completely sealed inside a standard nasogastric tube.
Here's an analysis of the provided text regarding the Surgi-Vision Endo-Esophageal MRI Coil, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Testing Conducted | Reported Device Performance |
|---|---|---|
| Safety - Heating | Possibility of excess RF heating (demonstrated no excess heating in phantom) | "no excess heating when EEMRI coil is positioned in a phantom that is representative of clinical conditions. The change in temperature observed during use of the EEMRI coil is the same as that observed without the coil." |
| Safety - Nerve Stimulation | Possibility of increased susceptibility of patients to peripheral nerve stimulation (demonstrated no increased susceptibility) | "The calculations and experiments done to determine current leakage by the MRI pulsed gradient field demonstrate that there is no possibility of increased susceptibility of patients to nerve stimulation." |
| Imaging Performance | Imaging performance (demonstrated enhanced resolution) | "the imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus." |
| Overall Safety | No safety problems if instructions for use are followed and SAR is within limits | "no safety problems for imaging of a patient using the Surgi-Vision Endo-Esophageal MRI Coil if the instructions for use are followed and if the whole-body average SAR is no more than the present recommended limit of 4 W/kg." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for the test set. It mentions "experiments" for heating and "calculations and experiments" for nerve stimulation, and "imaging performance," but no details on the number of subjects (human or phantom) or cases used.
The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing likely occurred in a controlled lab or internal facility given the nature of premarket submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on direct measurements and observations during testing (e.g., temperature changes, current leakage, visual assessment of image resolution).
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned, as the study does not describe a scenario where multiple readers or assessors would be making subjective evaluations that require adjudication. The testing seems to be based on objective physical measurements and direct observation of imaging output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on the device's technical performance and safety compared to the predicate device's function, not on comparing human reader performance with and without AI assistance. The device itself is a passive imaging coil, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not applicable in the context of this device. The Surgi-Vision Endo-Esophageal MRI Coil is a hardware accessory for an MRI machine, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted or relevant. The "performance" described refers to the coil's ability to produce clear images.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance appears to be based on:
- Direct Physical Measurements (quantitative): For heating (temperature change) and nerve stimulation (current leakage calculations and experiments).
- Direct Visual Assessment (qualitative/semi-quantitative): For imaging performance, where "enhanced resolution of aortic regions visualized from the esophagus" implies a visual comparison of image quality.
It does not utilize expert consensus, pathology, or outcomes data as "ground truth" in the way an AI diagnostic tool would.
8. The Sample Size for the Training Set
This device does not involve a training set. As a hardware device, it is not "trained" in the manner of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this hardware device.
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