(69 days)
The Indications for Use for the Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the imaging performance of the Signa Profile System. The Quadrature Thoracic / Lumbar spine Phased Array coil can also be used to image the following regions of anatomy: Thoracic Spine, Lumbar Spine, Chest, Abdomen, Pelvis, Hips.
The Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil is a receive only coil and can receive the quadrature signal. It is designed for use with a vertical magnetic field MR imaging system.
The provided text is a 510(k) summary for a medical device (Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil). It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for specific performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not explicitly present in the given document. The document primarily states that the device was evaluated to appropriate NEMA performance standards and International safety standards (IEC 601-1 and IEC 601-2-33) and performed to stated specifications. However, it does not elaborate on what those specific performance criteria were or how the device's performance measured against them.
Here's a breakdown of what can be extracted, and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NEMA performance standards | Evaluated to appropriate NEMA performance standards. Performed to stated specifications. |
| IEC 601-1 safety standards | Evaluated to IEC 601-1. Performed to stated specifications. |
| IEC 601-2-33 safety standards | Evaluated to IEC 601-2-33. Performed to stated specifications. |
| Substantial Equivalence to Signa Profile Body Flexible Coil | The coil does not result in any new potential hazards. Substantially equivalent to the presently marketed Signa Profile Body Flexible Coil. |
Missing Information: The document does not provide specific numerical or qualitative performance metrics against which the device was evaluated for NEMA or IEC standards. It only states that the device "performed to stated specifications" without detailing those specifications.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The study appears to be a technical evaluation of the coil's performance against standards, not a clinical study with patient samples.
- Data Provenance: Not applicable in the context of a technical performance evaluation described. The evaluation was likely performed in a lab setting by the manufacturer (GE Yokogawa Medical Systems, Ltd. in Tokyo, Japan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The "ground truth" here would be the adherence to technical standards and specifications, not clinical diagnoses requiring expert consensus.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. Standard compliance is typically verified through testing against defined protocols, not through expert adjudication in this context.
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
- MRMC Study: No, this was not an MRMC study. This device is an MR coil, not an AI-assisted diagnostic tool for interpretation by human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a hardware component (an MR coil), not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" implicitly referred to here are the technical specifications and performance requirements outlined in the NEMA and IEC standards. The device's performance was measured against these predefined engineering and safety benchmarks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: 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.