(30 days)
The coil is indicated for use, on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment.
Not Found
The provided text outlines the FDA's clearance of the Invivo Corporation's Model HRK-63-16 and HRK-127-16 Knee Array Coils but does not contain information regarding objective performance criteria, a study proving the device meets these criteria, or details of algorithm performance.
The document is a 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device. This process primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than establishing efficacy against predefined objective performance criteria through a specific clinical study for the new device.
Therefore, the requested information elements cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- 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 provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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 coil device, not an AI algorithm, and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document indicates that the device is an "accessory to produce images of the anatomy of interest, as an aid to diagnosis/treatment" in conjunction with an MR scanner. The clearance is based on the device being "substantially equivalent" to predicate devices, meaning it likely underwent testing to ensure specifications (e.g., signal-to-noise ratio, image uniformity, mechanical integrity) were comparable or better than existing coils, but these specific test results and acceptance criteria are not detailed in this regulatory letter.
§ 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.