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510(k) Data Aggregation
(139 days)
The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.
The 1.5T 24E Posterior Array is receive only phased array coil to produce diagnostic images of Spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone.
The 1.5T 24E Posterior Array 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 is a 510(k) Summary for a medical device (1.5T 24E Posterior Array, a receive-only MRI coil). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that the device meets specific acceptance criteria for performance in the same way an AI-based diagnostic device might.
The document focuses on engineering and basic performance tests typical for an MRI coil, rather than on diagnostic accuracy metrics. Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of device and submission.
Here's an analysis of the provided information, addressing the relevant points and noting non-applicable ones:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance |
|---|---|
| Image Uniformity (NEMA MS 3-2008): The device should meet specified requirements for image uniformity. | Bench testing was conducted to demonstrate that image uniformity met specified requirements. The test results show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards. |
| Signal-to-Noise Ratio (SNR) (NEMA MS-1-2008): The device should meet specified requirements for SNR. | Bench testing was conducted to demonstrate that SNR met specified requirements. The test results show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards. |
| Coil Surface Heating: The device should meet specified requirements for coil surface heating. | Bench testing was conducted to demonstrate that coil surface heating met specified requirements. The test results show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards. |
| Clinical Image Quality: Sample clinical images obtained with the device should be of sufficient quality for diagnostic use. | "The sample images obtained using the 1.5T 24E Posterior Array are of sufficient quality for diagnosis use." (This is a qualitative statement, without specific quantitative metrics or thresholds provided.) |
| Electrical Safety (IEC 60601-1:2005 + A1:2012): Compliance with general requirements for basic safety and essential performance. | "All verification tests have been performed according to below standard, the testing results are passed... 1. IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" |
| Electromagnetic Compatibility (IEC 60601-1-2:2014): Compliance with requirements and tests for electromagnetic compatibility. | "All verification tests have been performed according to below standard, the testing results are passed... 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" |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009): Materials in contact with the patient must pass in vitro cytotoxicity tests. | "All verification tests have been performed according to below standard, the testing results are passed... 3. ISO 10993-5:2009: Biological evaluation of medical devices. Part 5-Tests for in vitro cytotoxicity." |
| Biocompatibility - Irritation & Sensitization (ISO 10993-10:2010): Materials in contact with the patient must pass irritation and skin sensitization tests. | "All verification tests have been performed according to below standard, the testing results are passed... 4. ISO 10993-10:2010 Biological evaluation of medical devices, Part 10-Tests for irritation and skin sensitization." |
| Particular Requirements for MR Equipment (IEC 60601-2-33:2010+A1:2013+A2:2015): Compliance with basic safety and essential performance for MR equipment. | "All verification tests have been performed according to below standard, the testing results are passed... 7. IEC 60601-2-33:2010+A1:2013+A2:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis." |
| Preamplifier Noise: 0.5dB (as stated for predicate device, implied acceptance criterion for subject device) | "0.5dB" (Subject device matches predicate device) |
2. Sample size used for the test set and the data provenance
The document indicates "sample clinical images have been obtained with the 1.5T 24E Posterior Array from different anatomical sites and using various pulse sequences" but does not specify the sample size (number of patients or images) for this clinical evaluation. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified. This is typical for a 510(k) for an MRI coil, where the focus is on engineering metrics and general image quality rather than diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device submission. The clinical evaluation involves a qualitative assessment of image quality for diagnostic use, rather than a diagnostic accuracy study requiring ground truth established by multiple experts. The statement "can be interpreted by a trained physician" implies general medical expertise rather than a specific number or qualification of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device submission, as it relates to diagnostic disagreement resolution, which is not 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 device is an MRI receive coil, not an AI diagnostic device. No MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is hardware (an MRI coil), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "sufficient quality for diagnostic use" assessment in the clinical evaluation, the "ground truth" would implicitly be the opinion of "a trained physician" that the images are adequate for diagnosis, rather than a formal ground truth like pathology or outcomes data. This is a general judgment of image utility, not a specific diagnostic accuracy evaluation.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device and does not have a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device and does not have a training set.
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