(97 days)
The intended use of the 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner, body imaging for diagnostic with a MRI system.
It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure can be taken.
The 16 Ch Multipurpose Coil Variety described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 1.5 T or 3 T. The coil system serves only as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the 16 Ch Multipurpose Coil Variety which are digitized and further processed in the MRT system
The provided text is a 510(k) summary for the NORAS 16 Ch Multipurpose Coil Variety, a Magnetic Resonance Diagnostic Device. This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that would be typically found in a clinical study report for an AI/ML medical device.
Therefore, I cannot fulfill all aspects of your request based on the provided text.
Here is what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here is substantial equivalence to predicate devices, meaning the device's performance is expected to be comparable to already cleared devices.
- Reported Device Performance: The document only states that the device is "safe and effective when used with the currently available Siemens MAGNETOM 1.5T/3T" based on conformity to NEMA and IEC standards for safety and performance. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided or compared to a threshold.
| Criterion Type | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety & Efficacy | Conformity to NEMA Standards for performance and safety, and IEC 60601-2-33:2002 for safety issues with Magnetic Resonance Imaging Devices. | "Safe and effective when used with the currently available Siemens MAGNETOM 1.5T/3T" |
| Substantial Equivalence | The 16 Ch Multipurpose Coil Variety is substantially equivalent to the predicate devices: 8 Ch Multipurpose Coil (K083578) and 8-Channel Medium General Purpose Flex Coil (K111673) | Believed to be substantially equivalent based on intended use, technological characteristics, and safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not mentioned. This document describes a new hardware device (an MRI coil), not an AI/ML algorithm that would typically undergo testing with a separate test set of data. The "testing" appears to be focused on engineering and safety standards compliance.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML 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 relates to a hardware device (MRI coil), not an AI/ML algorithm requiring expert ground truth for image interpretation. The "ground truth" for the coil's performance would be physical measurements of signal-to-noise ratio, uniformity, safety parameters, etc.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for establishing ground truth in clinical imaging studies for AI/ML algorithms.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred Ground Truth: For a new MRI coil, the "ground truth" for its performance would likely be based on established engineering and physics principles, direct measurements of coil characteristics (e.g., signal-to-noise ratio, homogeneity, artifact levels), and compliance with international standards (NEMA, IEC 60601-2-33). It would not involve clinical image interpretation ground truth in the way an AI algorithm would.
8. The sample size for the training set
- Not applicable. This is a hardware device, not an AI/ML model that undergoes training on a dataset.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model is mentioned.
§ 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.