Search Results
Found 1 results
510(k) Data Aggregation
(14 days)
Imaging of:
- Diagnostic imaging of the knee, ankle and foot regions
- Fluid visualization
- 2D and 3D imaging
- MR angiography
- MR fluoroscopy
The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.
The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.
The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.
The provided text describes a 510(k) summary for a medical device called the "QD KNEE/FOOT COIL." It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical study for an AI/ML medical device would.
This document is a premarket notification for a hardware accessory (an MRI coil) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than performance against a set of quantitative acceptance criteria in a study. The information provided is about the device's technical specifications and intended use.
Therefore, many of the requested categories cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't outline specific "acceptance criteria" in the sense of predefined thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that an AI device would need to meet. Instead, it details safety parameters and imaging performance parameters, which are more akin to technical specifications for the hardware. The "reported device performance" is largely qualitative, referring to sample images.
| Parameter | Acceptance Criteria (Implicit/Stated) | Reported Device Performance |
|---|---|---|
| Safety Parameters | ||
| Maximum static field strength | 1.5 Tesla (This is a specification of the compatible MRI system, not the coil's intrinsic performance, but implies it must operate safely at this field strength) | N/A (The coil is designed for a system with this field strength) |
| Rate of change of magnetic field | 30 mT/second (Maximum safe rate of change for the compatible MRI system) | N/A |
| Maximum radio frequency power deposition (SAR) | < 4.8 watt/kg (Maximum safe SAR for the compatible MRI system during operation with the coil) | N/A |
| Acoustic noise levels (maximum) | 110 dB(A-weighted) (Maximum safe acoustic noise level for the compatible MRI system during operation with the coil) | N/A |
| Imaging Performance Parameters | ||
| Specification volume | 15 cm dsv (This describes the desired effective imaging volume of the coil) | "Sample phantom images and clinical images are presented in Appendix F & G." (Qualitative demonstration of imaging capability within the specified volume) |
| Anatomical regions | Knee, ankle and foot regions (Intended use regions) | Imaging of these regions is intended and demonstrated qualitatively. |
| Nuclei excited | Hydrogen (Standard for clinical MRI) | N/A |
| Diagnostic Use | Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy (Intended diagnostic capabilities) | Images are shown to support these capabilities. |
Regarding the study that proves the device meets the acceptance criteria, and further details you requested:
The provided document is a 510(k) summary for a hardware device, not an AI/ML diagnostic system. Therefore, it does not contain information on the following as these concepts are not applicable to this type of submission:
- Sample size used for the test set and the data provenance: Not applicable. The "study" here is primarily demonstrating technical specifications and substantial equivalence, not clinical diagnostic performance on a specific dataset. "Sample images" are mentioned but not described as a formal test set for statistical analysis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance isn't established for this hardware accessory.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a hardware device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
Summary based on the document:
The QD Knee/Foot Coil demonstrated its technical specifications and performance through phantom and clinical images, which were presented in confidential appendices (F & G) to the FDA. The primary "proof" of meeting safety and effectiveness involves demonstrating that the device adheres to MRI safety standards and provides images suitable for its stated diagnostic uses, and is substantially equivalent to a previously cleared predicate device (QD Knee coil, K032490). The "study" refers to the engineering and testing that confirmed the specified parameters and image quality, rather than a clinical trial with statistical performance metrics on a patient cohort that would be relevant for an AI/ML device.
Ask a specific question about this device
Page 1 of 1