(75 days)
The Surgi-Vision Esophageal Stylet Coil is recommended for highresolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable 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 Esophageal Stylet 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 the insulating layer.
The provided document is a 510(k) summary for the Surgi-Vision Esophageal Stylet Coil, indicating that it is a medical device submission to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study proving the device meets specific acceptance criteria in the way AI/ML devices typically would.
Therefore, much of the requested information (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or cannot be extracted from this type of regulatory document.
However, I can organize the available information into the requested format where possible.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Safety - RF Heating | No excess heating when positioned in a phantom representative of clinical conditions. | The results of heating experiments demonstrate there is no excess heating. The change in temperature observed during use is not significantly different than that observed without the coil. |
| Safety - Nerve Stimulation | No increased susceptibility of patients to peripheral nerve stimulation. | Experiments on current leakage by the MRI pulsed gradient field demonstrate there is no possibility of increased susceptibility of patients to nerve stimulation. |
| Performance - Imaging Quality | Enhanced resolution of aortic regions visualized from the esophagus. | Imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus. |
| Compliance - Instructions for Use | Safe for imaging a patient if instructions for use are followed. | The results of testing demonstrate no safety problems if instructions for use are followed. |
| Compliance - SAR Limit | Safe for imaging a patient if the whole-body average SAR is no more than the present recommended limit of 4 W/kg. | The results of testing demonstrate no safety problems if the whole-body average SAR is no more than the present recommended limit of 4 W/kg. |
| Substantial Equivalence | Identical indications for use as the predicate device. Same technological characteristics as the predicate device (matching circuit, coaxial cable, RF coil). | The device has identical indications for use as the legally marketed predicate device (Surgi-Vision Endo-Esophageal MRI Coil, K992193). The device has the same technological characteristics (electronic matching circuit, connecting coaxial cable, inter-cavitary probe with radiofrequency receiving coil). |
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 describes phantom testing for safety and performance, not a clinical test set with human subject data. Therefore, concepts like "sample size for the test set" and "data provenance" (country/retrospective/prospective) are not applicable in their usual clinical study context.
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)
Not applicable. The safety and performance testing involved physical measurements (heating, current leakage) and imaging performance in a phantom. There is no mention of expert consensus for ground truth on a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human-read test set data is 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
Not applicable. This is a medical device for improved MRI imaging quality, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a passive MRI coil, not an algorithm. The "standalone" performance here refers to the coil's physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For safety criteria (RF heating, nerve stimulation), the ground truth was based on physical measurements and established scientific thresholds/limits (e.g., 4 W/kg SAR limit).
For imaging performance, the ground truth for "enhanced resolution" would likely be based on objective image quality metrics in the phantom, possibly compared to images acquired without the device, though the document does not specify these metrics.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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.