(119 days)
The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.
The 8ch T/R Knee Coil is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist. The 8ch T/R Knee 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 provided text describes the 510(k) premarket notification for the "8ch T/R Knee Coil" by Shenzhen RF Tech Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and safety and performance through bench testing, rather than an AI/ML-based device requiring extensive clinical study for performance metrics like sensitivity and specificity.
Therefore, the following information is extracted from the provided text according to the specific questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative performance table (e.g., specific SNR thresholds for passing). Instead, it states that the device "met specified requirements" for various tests as demonstrated through bench testing. The criteria are implied to be conformance to the listed standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to IEC 60601-1 (Basic safety & essential performance) | Demonstrated conformance; tests passed |
| Conformance to IEC 60601-1-2 (EMC) | Demonstrated conformance; tests passed |
| Conformance to ISO 10993-5 (In vitro cytotoxicity) | Demonstrated conformance; tests passed |
| Conformance to ISO 10993-10 (Irritation & skin sensitization) | Demonstrated conformance; tests passed |
| Conformance to NEMA MS-1 (SNR determination) | Met specified requirements for SNR; tests passed |
| Conformance to NEMA MS-3 (Image uniformity determination) | Met specified requirements for image uniformity; tests passed |
| Conformance to IEC 60601-2-33 (MR equipment safety/performance) | Demonstrated conformance; tests passed |
| Coil surface heating within specified requirements | Met specified requirements for coil surface heating; tests passed |
| Performance as well as the legally marketed predicate device | Considered to perform as well as the predicate device |
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 "bench testing" of the device. There is no mention of a "test set" in the context of patient data or clinical images. The testing involved physical tests of the device itself. Therefore, sample size and data provenance in this context are not applicable in the way they would be for an AI/ML diagnostic algorithm.
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. This device is an MRI coil, not an AI diagnostic algorithm requiring expert "ground truth" for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" in the context of clinical images requiring adjudication.
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 device is an MRI coil, not an AI solution intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI coil, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's testing relates to established engineering and safety standards (e.g., material biocompatibility, electrical safety, signal-to-noise ratio measurements, image uniformity).
8. The sample size for the training set
Not applicable. This device is an MRI coil and does not involve AI/ML modeling that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. 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.