(73 days)
The Indications for Use for the Signa Profile Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the ankle, wrist, cervical-spine and surrounding structures in a dynamic and kinematic motions.
The Kinematic Positioners provide support for the ankle, wrist and cervical spine for MR scanning. They have two usage's; one is for a scan when the scanned area is fixed, and the other is while the scanned area is moving.
This document describes the Signa Profile Kinematic Positioner Options, an accessory for MR scanning. It is not a software or AI device, and therefore, the requested information about acceptance criteria, study details for a device meeting those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth definitions are not applicable to this product.
The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device and compliance with safety standards, not on performance metrics typically associated with AI or software-driven diagnostic tools.
Here's a breakdown of the information that is available in the document, acknowledging that most of your request is not relevant for this type of product:
Summary of Device and Evaluation:
The Signa Profile Kinematic Positioner Options are physical accessories designed to support the ankle, wrist, and cervical spine during MR scanning. They facilitate imaging of these areas in dynamic and kinematic motion.
Key takeaway for your request: Because this is a mechanical accessory and not a diagnostic software, the concepts of "acceptance criteria" for diagnostic performance (like sensitivity, specificity, etc.), "ground truth," "expert readers," and "AI assistance" do not apply.
General Information Present in the Document:
- Device Name: Signa Profile Kinematic Positioner Options
- Manufacturer: GE Yokogawa Medical Systems, Ltd.
- Submitter: GE Medical Systems
- FDA K-number: K972704
- Submission Date: July 17, 1997
- Marketed Devices: Stated as substantially equivalent to the currently marketed Signa Profile System (software and electronics).
- Device Description: Provides support for the ankle, wrist, and cervical spine for MR scanning, with two usages: fixed scanned area and moving scanned area.
- Indications for Use: Expands the capability of the Signa Profile System, accommodating and improving imaging of the cervical spine, wrist, ankle, and surrounding structures in dynamic and kinematic motion.
- Summary of Studies: The options were evaluated for safety to International Safety Standards IEC 601-1 and IEC 601-2-33.
- Conclusions: The device performed to stated specifications and is in compliance with the IEC Standards. GE concludes the options are substantially equivalent to the presently marketed Signa Profile System and do not result in new potential hazards.
Regarding your specific numbered requests, and why they cannot be answered from this document:
- A table of acceptance criteria and the reported device performance: Not applicable. This document refers to compliance with safety standards (IEC 601-1, IEC 601-2-33), not diagnostic performance metrics. There are no "reported device performance" values like sensitivity or specificity.
- Sample size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of diagnostic performance data. The device was evaluated against safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance was established.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for diagnostic performance.
- 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. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not a standalone algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth was needed for this type of product evaluation.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
In essence, the "study" mentioned for this device was a safety evaluation against established international standards (IEC 601-1 and IEC 601-2-33), not a diagnostic performance study.
§ 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.