(14 days)
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
The provided text describes a 510(k) premarket notification for a medical device, the MC 3003G-32R Head Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria as might be seen for novel devices.
Therefore, the document does not contain information about specific "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, or image quality metrics with thresholds) or a "study that proves the device meets the acceptance criteria" in the way one might expect for a new diagnostic algorithm or AI product.
Instead, the submission for the MC 3003G-32R Head Coil demonstrates substantial equivalence primarily by comparing its design, intended use, and performance to a predicate device, focusing on safety and basic functional performance.
Here's a breakdown of the information that is available in the document, acknowledging that it doesn't directly address the structured questions about acceptance criteria for diagnostic performance:
1. A table of acceptance criteria and the reported device performance
- No specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in the document.
- The document states that "Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met." However, the specific metrics and thresholds for these design specifications and customer requirements are not detailed.
- Reported Device Performance (as implied by the "Summary of Studies"):
- Electrical bench measurements
- Electrical/mechanical safety tests
- System safety and performance tests with phantoms
- Predicate device comparison tests
- Volunteer scans
- The primary functional difference highlighted is that the MC 3003G-32R Head Coil has a "32 element phased array RF structure as opposed to a 8 element phased array RF structure" of the predicate, which "may increase coil sensitivity and may reduce data acquisition time." This implies improved performance but doesn't quantify it against specific acceptance criteria.
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 mentions "volunteer scans" as part of the testing activities, but does not specify the sample size of these volunteers.
- Data provenance is not specified. The studies were "conducted using the GE Healthcare Signa 3.0T MR System running standard clinical applications."
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 / Not provided. The "volunteer scans" are mentioned, and the intended use states that "when interpreted by a trained physician yield information that may assist in diagnosis." However, the document does not describe a study involving expert interpretation for establishing ground truth or performance metrics against such ground truth for the device itself. The focus is on safety and technical performance of the coil.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Since there's no mention of a diagnostic performance study with expert interpretation for ground truth, there's no adjudication method 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
- No. This device is an MR head coil, a hardware component for image acquisition, not an Artificial Intelligence (AI) diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware; it is not an algorithm, so a standalone algorithm-only performance study would not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly described for diagnostic performance. For the "system safety and performance tests with phantoms," the ground truth would be the known properties and geometry of the phantoms. For "electrical bench measurements" and "electrical/mechanical safety tests," the ground truth would be engineering specifications and safety standards. For "volunteer scans," the purpose seems to be confirming image acquisition capability and safety, rather than a diagnostic performance study against a definitive clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is hardware and does not involve a training set as would an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is involved.
Summary of the Study Mentioned (from "Summary of Studies"):
The study described is a design verification and validation process for a hardware device (an MR head coil). It included:
- Electrical bench measurements: Likely verifying electrical specifications.
- Electrical/mechanical safety tests: Ensuring the device meets safety standards.
- System safety and performance tests with phantoms: Using standardized objects with known properties to assess image quality, signal-to-noise ratio, uniformity, etc., under controlled conditions. This would be a technical performance evaluation, not a clinical diagnostic one.
- Predicate device comparison tests: Direct comparison of the new coil's performance (likely technical and imaging characteristics) against the predicate.
- Volunteer scans: Scans on human volunteers to confirm safe operation and the ability to acquire images, consistent with its intended use for generating images of the head.
The study's goal was to demonstrate that the MC 3003G-32R Head Coil is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness for its intended use, rather than to meet specific diagnostic performance metrics through a clinical trial.
§ 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.