(90 days)
The new kinematic knee device will enable the physician to evaluate the anatomy of the knee and dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such dynamic evaluation may be useful for patellar tracking.
Siemens is introducing a new positioning device that will be used for kinematic MRI studies of the knee. The new positioning device can be used for the left or right knee and is adjustable up to a maximum angle of 100 degrees.
This document, K961121, describes a 510(k) premarket notification for a Siemens Kinematic Knee Device. The central claim is that the new device is substantially equivalent to an existing device, the Resonex Kinematic MRI Package (K924154).
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not specify acceptance criteria or report a device performance study in terms of objective metrics (e.g., sensitivity, specificity, accuracy). The submission focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No test set, study, or data provenance is mentioned. The submission relies on a claim of substantial equivalence to a previously cleared device.
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. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication process is 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 MRMC study was done, nor is there any mention of AI in this submission. This is a submission for a physical positioning device, not an AI or algorithmic diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical positioning accessory, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described. The submission focuses on the mechanical and functional similarity to a predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI or algorithmic device.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment is described.
Summary of the Study (or lack thereof):
The provided document describes a 510(k) premarket notification for a new kinematic knee positioning device. The "study" presented here is a substantial equivalence claim, not a performance study measuring the device's diagnostic accuracy or effectiveness against a set of criteria.
The basis for calling the device "safe and effective" and meeting "acceptance criteria" (though not explicitly stated) is its purported substantial equivalence to the Resonex Kinematic MRI Package (K924154), which received FDA premarket clearance on November 23, 1992. The submission argues that the new device's technological characteristics (manually operated, no active components, no ferromagnetic materials) will not affect the safety and performance of the MAGNETOM OPEN MRI system it's used with.
Essentially, the "proof" is the argument of substantial equivalence to a predicate device that has already been deemed safe and effective by the FDA, rather than an independent performance study of the new device itself.
§ 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.