(89 days)
The Picker International Outlook system is intended for use as a NMR device that produces images that: ( ) ) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder.
The Outlook C-spine positioning device is designed to keep the head of the patient constrained in different positions while the C-spine is being imaged in the Outlook scanner. The device allows flexion, extension, lateral movement and lateral rotation. There is also a possibility to set the distance between the horizontal (flexion/extension) axis and the vertical axis (lateral motion). The device has an integrated holder for the Multipurpose receiver coil.
The Outlook Knee positioning device is designed to keep the leg constrained in different positions while the knee joint is imaged in the Outlook system with a Multipurpose coil. The device is used for flexion and extension of the knee.
The Outlook Knee positioning device is designed to keep the arm of the patient constrained in different positions while the shoulder joint is being imaged in the Outlook scanner. The device allows abduction, adduction and internal/external rotation. The device has an integrated holder for the Multipurpose receiver coil.
This document describes a 510(k) submission for Kinematic Positioning Devices for Magnetic Resonance (MR) Imaging Systems. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available in this document.
Here's a breakdown of the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission is a 510(k) for substantial equivalence, focusing on comparing technical characteristics and intended use to a predicate device, rather than presenting a performance study with acceptance criteria. The "Safety and Effectiveness" section explicitly states: "The Picker International Kinematic Positioning Devices for the Outlook are similar in technological characteristics and intended use to the Siemen's Kinematic Knee Device for the Magnetom Open System (K961121). The following chart has been created to demonstrate their substantial equivalence."
The table provided compares parameters like:
| Parameter | Kinematic Positioning Devices for the Outlook | Predicate Device Kinematic Knee Device for the Magnetom Open System (K961121) |
|---|---|---|
| Material | Same | No ferromagnetic materials which could affect the scan field. |
| Device operation | Same | Manually operated by the user. No active components such as motors. |
| Indications for Use | C-Spine, Knee, Shoulder scanning | Knee scanning |
| Intended use | (Description of Picker International Outlook MR system) The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat) | (Description of Siemens Magnetom Open MR system) The 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). |
The reported "performance" for the new device is the assertion that it is "Same" in material and device operation to the predicate device, implying it performs equivalently in these aspects. There are no quantitative performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No specific test set or data provenance is mentioned as this is a substantial equivalence submission, not a clinical performance study.
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)
This information is not provided in the document. No "ground truth" establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is a physical positioning device for MR imaging, not an AI or software-based diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No ground truth establishment is described.
8. The sample size for the training set
This information is not provided in the document. This is a physical medical device, not a machine learning model, so a "training set" in that context is not applicable.
9. How the ground truth for the training set was established
This information is not provided in the document. As this is not a machine learning device, the concept of a "training set" and its ground truth is not applicable.
§ 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.