(49 days)
The 8ch Wrist Coil by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.
The 8ch Wrist Coil is receive only phased array coil to produce diagnostic images of the wrists and fingers in adult population.
The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
The 8ch Wrist Coil is based on phased array technique to produce the images from 8 different channels with intergraded preamplifiers. The 8ch Wrist Coil is tuned to the proton frequency of 63.86MHz.
The provided text is a 510(k) Summary for the 8ch Wrist Coil, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of an AI algorithm's performance. Therefore, much of the requested information regarding AI algorithm performance (e.g., acceptance criteria for AI, training set details, multi-reader multi-case studies) is not present in this document.
However, based on the information provided, I can address the aspects related to the device's performance and validation, particularly in relation to its physical and imaging characteristics:
Acceptance Criteria and Device Performance for 8ch Wrist Coil
The document primarily focuses on demonstrating that the 8ch Wrist Coil performs "as well as" the predicate device and meets established industry standards for MRI coils.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functional Equivalence | Indicated Use (for wrists/fingers, diagnostic images, trained physician interpretation) | "The 8ch Wrist Coil by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician." (Matches predicate's broader wrist/hand indication, extended to 'fingers') |
| Anatomical Site | Wrist/Fingers (Predicate: Wrist/Hand) | |
| Transmit/Receive Type | RF coil (receive only) | |
| Number of Channels | 8CH | |
| Field Strength Compatibility | 1.5 T | |
| Preamplifier Noise | 0.5dB | |
| Energy Source | Scanner/DC 10V | |
| Compatible Systems | GE 1.5T MRI systems | |
| Coil Design | Phased array | |
| Tuning | Hydrogen (~64MHz) (Proton frequency of 63.86MHz stated elsewhere) | |
| Decoupling Method | Yes, active + passive | |
| Performance Metrics | Image Uniformity | "Bench testing was conducted to demonstrate that image uniformity...met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above." (Implies meeting NEMA MS 3-2008) |
| Signal-to-Noise Ratio (SNR) | "Bench testing was conducted to demonstrate that ...SNR...met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above." (Implies meeting NEMA MS-1-2008) | |
| Coil Surface Heating | "Bench testing was conducted to demonstrate that ...coil surface heating met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above." | |
| Safety & Biocompatibility | Biocompatibility of Patient-Contacting Materials | "Patient-contacting materials assessed for compliance with biocompatibility standards: Yes." "The biocompatibility of material used is both compliance with ISO 10993-5 and ISO 10993-10." |
| Electrical Safety (General Requirements) | "All verification tests have been performed according to below standard, the testing results are passed 1. ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;" | |
| Electromagnetic Compatibility (EMC) | "2. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;" | |
| MRI Equipment Specific Requirements | "7. IEC 60601-2-33:2010+A1:2013+A2:2015 Medical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis." |
The study proving the device meets these criteria is the "Summary of verification Tests," which states: "Bench testing was conducted to demonstrate that image uniformity, SNR and coil surface heating met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above."
Regarding AI-specific criteria, the document does not present information about an AI algorithm. This device is a passive MRI coil, not an AI software. Therefore, the following points are not applicable based on the provided text:
- 2. Sample size used for the test set and the data provenance: Not applicable for a hardware device validation based on bench testing. The "test set" here refers to the physical coil and its performance measurements.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is established by metrology and standard comparisons (e.g., NEMA, IEC).
- 4. Ground truth Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a hardware device, not an AI algorithm.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the hardware coil, the "ground truth" for its performance (SNR, uniformity) is established by adherence to recognized industry standards (NEMA MS-1, NEMA MS-3) and validated bench testing procedures.
- 8. The sample size for the training set: Not applicable (no AI component).
- 9. How the ground truth for the training set was established: Not applicable (no AI component).
§ 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.