(39 days)
To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are receive-only phased array RF coils designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Maqnetic Resonance Imaging (MRI) scanners. The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.
Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy.
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.
This document describes the marketing approval of NeoCoil's 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil, which are Magnetic Resonance (MR) diagnostic devices. The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611).
The provided document, however, does not contain a specific table of acceptance criteria with reported quantitative performance metrics for the image quality or diagnostic accuracy studies for a novel AI device. Instead, it details the acceptance criteria met for establishing substantial equivalence for an MRI coil. The studies conducted focus on the safety and effectiveness of the coil itself as a medical device component, not on the performance of an AI algorithm interpreting images.
Therefore, I will interpret the request in the context of demonstrating substantial equivalence for an MRI coil, rather than an AI diagnostic device. The "performance" here refers to the physical and electrical performance of the coil that ensures it can produce diagnostic images, rather than algorithmic performance metrics like sensitivity or specificity.
Here's an analysis of the provided information in the requested format, adapted for an MRI coil rather than an AI diagnostic device:
Acceptance Criteria and Study for NeoCoil 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil
The acceptance criteria for these MRI coils are primarily based on demonstrating substantial equivalence to a predicate device (NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611), ensuring the new coils are safe and effective for their intended use. The performance evaluation includes both non-clinical (bench) and clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Objective(s) | Pre-defined Pass/Fail Criteria (General) | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Biocompatibility | Assess potential biological risks | Acceptable level of risk | No identified significant risks. | Pass |
| Electrical Safety | Basic electrical safety/essential performance (IEC 60601-1) | Pre-defined performance standards | Applicable requirements for basic electrical safety and essential performance met. | Pass |
| Electrical Safety (MR) | Particular electrical requirements; MR equipment (IEC 60601-2-33) | Pre-defined performance standards | Applicable requirements of the particular standard were met. | Pass |
| Electrical Safety (Collateral) | Collateral electrical safety/essential performance (IEC 60601-1-2) | Pre-defined performance standards | Applicable requirements of the collateral standard were met. | Pass |
| Usability Assessment | Devices meet customer, end user and patient needs | Pre-defined requirements | The devices met the needs of the customer, end user, and patient. | Pass |
| Entrapment, Trapping Zone, and Cable Looping | Assess the device for pinch points, entrapment, cable looping - interfacing with MRI scanner | Requirements based on pre-defined requirements in 60601-1 and customer requirements | Requirements were met. | Pass |
| Surface Temperature | Surface temperatures do not exceed limits | Pre-defined performance standards (IEC limits) | Surface temperatures were within IEC limits. | Pass |
| Unplugged Surface Temperature | Devices remain safe in first fault condition (when unplugged in scanner) | Acceptable level of risk (IEC limits) | Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner. | Pass |
| Blocking Network Analysis | Ensures devices are designed with adequate active and passive transmit decoupling | Adequate transmit decoupling | Blocking network demonstrates adequate active and passive transmit decoupling. | Pass |
| Maximum B1 Peak | Demonstrate the devices can withstand the maximum B1 peak without obvious signs of arcing, burning, voltage breakdown | Pre-defined performance standards | Coils were able to withstand maximum B1 peak without obvious signs of arcing, burning or voltage breakdown. | Pass |
| B1 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | Pre-defined performance standards | B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. | Pass |
| B0 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | Pre-defined performance standards | B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. | Pass |
| NEMA MS 6-2008 (SNR & Image Uniformity) | Evaluate single-channel non-volume special purpose radio-frequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems | Pre-defined performance standards | SNR and Image Uniformity are consistent with the requirements for indications for use. | Pass |
| Clinical Performance (Diagnostic Image Quality) | Produce diagnostic images of the shoulder that can be interpreted by a trained physician | Images suitable for diagnostic interpretation as per clinical assessment/comparison to predicate. | Performed clinical testing to exhibit a mix of technical factors and anatomy; No adverse events were reported. (Implies images were diagnostically acceptable) | Pass (Substantial Equivalence Demonstrated) |
2. Sample Size Used for the Test Set and Data Provenance
The document provides limited specific detail on the "sample size" in terms of number of patients or scans for the clinical testing. It states: "Clinical data exhibits a mix of technical factors and anatomy as recommended in the FDA guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016."
- Test Set Sample Size: Not explicitly quantified in terms of number of subjects/scans. The "clinical" section lists examples of sequences tested (e.g., Oblique Axial PD, Oblique Coronal T1). This suggests a limited number of test cases sufficient to demonstrate clinical image interpretability.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective or specifically conducted for regulatory submission, given the explicit mention of "Clinical performance testing" and comparison to FDA guidance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not explicitly provided in the document. For an MRI coil, the "ground truth" for diagnostic image quality would typically be judged by trained physicians (e.g., radiologists) interpreting the images. The document states the coils are "to produce diagnostic images of the shoulder that can be interpreted by a trained physician," implying such interpretation was part of the clinical assessment. However, the exact number and qualifications of these interpreting physicians are not detailed.
4. Adjudication Method for the Test Set
Not specified. For an MRI coil that is part of the image acquisition chain, the assessment is more about whether the images produced are diagnostically acceptable and substantially equivalent to images from the predicate device, rather than classifying presence/absence of a condition which would typically require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No evidence of a formal MRMC study as would be conducted for an AI diagnostic algorithm. The evaluation is focused on the coil's ability to produce diagnostically interpretable images comparable to the predicate. The statement "Clinical testing demonstrates that the differences in the compatible scanners of the devices do not affect the safety and/or the effectiveness of the device when used as labeled" and "Clinical and non-clinical testing demonstrates that the safety and effectiveness of the 1.5T 16ch Shoulder Coil compared to the predicate device is not adversely affected as a result of the differences" suggests a comparative assessment, but not an MRMC study measuring human reader performance with/without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This submission is for an MRI coil, which is a physical device component, not an AI algorithm. Its "standalone performance" refers to its physical and electrical characteristics (bench testing) and its ability to produce images, not to interpret them.
7. The Type of Ground Truth Used
- For the non-clinical (bench) testing:
- Engineering/Physics Measurements: Quantitative measurements (e.g., surface temperature, B1/B0 field distortion, SNR, image uniformity based on NEMA MS 6-2008).
- Compliance with Standards: Verification against recognized safety and performance standards (e.g., IEC 60601 series).
- For the clinical testing:
- Clinical Interpretability: The "ground truth" implies that the images produced by the new coils were subjectively assessed as being of sufficient diagnostic quality to be interpreted by a trained physician, in comparison to images from the predicate device. The absence of adverse events further supported the safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is for an MRI coil, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is for an MRI coil, not an AI algorithm.
§ 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.