(55 days)
The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil.
The Illuminator™ Automatic Tuning Interface Box (ATIB) provides an interface for the Illuminator™ Transesophageal Probe, the Illuminator ™ Surface Coil and the General Electric 1.5 T Signa® Magnetic Resonance Imaging (MRI) Systems. The device automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system. The Auto Tune Interface Box will be used in clinical MRI rooms. The interface box interfaces with the GE MRI machine through a cable bundle with a 30 pin connector box attached.
The document provided describes a 510(k) premarket notification for the Illuminator™ Automatic Tune Box and Interface Cable (ATIB). The focus of the submission is on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through extensive clinical studies and acceptance criteria in the way a new drug or high-risk medical device might.
Based on the provided text, here's a breakdown of the requested information, with limitations noted due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in the format typically seen for algorithm performance (e.g., target specificity, sensitivity, or AUC). Instead, the performance testing focuses on demonstrating equivalency of the new automatic tuning box to the previously cleared manual tune box.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Imaging Performance | Equivalent to manual tune box | Comparable to manual tune box |
| Signal to Noise | Equivalent to manual tune box | Comparable to manual tune box |
| Temperature | Safe operation | Data collected (implied safe) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Magna-Lab has performed testing and/or analysis of the Interface Box." This suggests internal testing without a explicitly defined "test set" in the context of a large-scale clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "ground truth" and expert consensus in the clinical interpretation sense (e.g., radiologists reviewing images) is not applicable or discussed for this device. The performance testing appears to be technical in nature, comparing physical characteristics like imaging quality, signal-to-noise ratio, and temperature, which would likely be evaluated by engineers or physicists.
4. Adjudication Method for the Test Set
Not applicable. The testing described is technical comparison, not a diagnostic assessment requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The device is an automatic tuning interface box, not a diagnostic algorithm that assists human readers in interpreting medical images. Therefore, an effect size of human improvement with or without AI assistance is not relevant or measurable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is an "automatic tune box," implying its operation is standalone in tuning the probe. However, the performance testing described is not an "algorithm-only" study in the sense of an AI model's diagnostic accuracy. It's about the physical and electrical performance of the new automatic mechanism compared to the old manual one.
7. Type of Ground Truth Used
The "ground truth" for the performance testing would be objective technical measurements related to MRI image quality (e.g., contrast, resolution, artifacts) and signal characteristics (e.g., SNR values) and temperature readings, all compared against baseline measurements from the manual tune box. It is not expert consensus, pathology, or outcomes data in a clinical diagnostic sense.
8. Sample Size for the Training Set
No training set is mentioned or applicable. The device is a hardware interface, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.