(59 days)
The 16ch Tx/Rx Knee SPEEDER is intended for use with Toshiba 3T MR systems to produce diagnostic images of the knee, wrist, hand, and forefoot that can be interpreted by a trained physician.
The 16ch Tx/Rx Knee SPEEDER is a transmit/receive coil designed for magnetic resonance imaging (MRI) using Toshiba 3T MRI systems. The device contains a 1-channel birdcage transmitter. Receive mode can be switched between 15-channel receive array and 1-channel birdcage receiver. The 16ch Tx/Rx Knee SPEEDER is intended to be used for imaging the knee, hand, wrist, and forefoot.
The 16ch Tx/Rx Knee SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
The 16ch Tx/Rx Knee SPEEDER also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.
The provided text describes a 510(k) premarket notification for a medical device, the 16ch Tx/Rx Knee SPEEDER, which is a magnetic resonance imaging (MRI) coil. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering and bench testing, rather than a clinical study focused on diagnostic accuracy with human-in-the-loop performance. Therefore, many of the requested elements pertaining to clinical study design, expert evaluation, and AI performance will not be available from this document.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Tested and found compliant (where testing was performed). |
| Biocompatibility: Irritation (ISO 10993-10) | Tested and found compliant (where testing was performed). |
| Biocompatibility: Sensitization (ISO 10993-10) | Tested and found compliant (where testing was performed). |
| Electrical Safety (AAMI/ANSI ES60601-1) | Compliant |
| Electromagnetic Compatibility (IEC 60601-2-33) | Compliant |
| Surface Heating (AAMI/ANSI ES60601-1) | Measured temperature never exceeded 41°C (maximum limit). |
| Specific Absorption Rate (SAR) (IEC 60601-2-33) | Whole body SAR below the limit. |
| Signal-to-Noise Ratio (SNR) (NEMA MS 6-2008) | Conformed to predetermined acceptance criteria. |
| Uniformity (NEMA MS 6-2008) | Conformed to predetermined acceptance criteria. |
| Clinical Image Quality | Produced diagnostic quality images of intended anatomies. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for specific tests.
- For biocompatibility, the materials themselves were tested.
- For electrical safety, EMC, surface heating, and SAR, the device was tested.
- For performance (SNR, uniformity), the device was tested per NEMA standards.
- For clinical image quality, images from "volunteer scanning" were obtained, but the number of volunteers is not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. The "volunteer scanning" for clinical images suggests prospective data collection in an unspecified location (likely Toshiba's or QED's testing facilities).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. For the primary performance criteria (SNR, uniformity, safety), ground truth is established by objective measurements against industry standards (NEMA, IEC, AAMI/ANSI).
- For clinical image quality, the statement "can be interpreted by a trained physician" implies that diagnostic quality is assessed by physicians, but the number of physicians involved in the assessment of the volunteer images or their qualifications is not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for the majority of the testing, which relies on objective measurements against engineering standards. For the qualitative assessment of "diagnostic quality images" from volunteer scans, no formal adjudication method (like 2+1 or 3+1 consensus) is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done or described in this document. The study primarily focuses on technical performance characteristics and demonstration of image quality from a volunteer scan, not on comparing diagnostic accuracy with human readers, with or without AI assistance.
- Effect Size of Human Readers with/without AI: Not applicable, as no AI component is mentioned, and no MRMC study was performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Standalone Performance Study: No, this device is an MRI coil, which is a hardware component. It does not have an "algorithm" in the sense of AI software for image interpretation. Its performance is inherent to its physical design and measured through technical parameters (e.g., SNR, uniformity).
7. Type of Ground Truth Used
- Type of Ground Truth: Primarily objective measurements against defined engineering and safety standards (e.g., NEMA MS 6-2008 for SNR and uniformity, AAMI/ANSI ES60601-1 and IEC 60601-2-33 for electrical safety, surface heating, and SAR, ISO 10993 for biocompatibility).
- For "diagnostic quality images," the ground truth is a qualitative assessment by the inherent ability of the produced images to be interpreted by a "trained physician," rather than a comparison to a definitive clinical diagnosis or pathology.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The device is a hardware component (MRI coil). It does not involve machine learning or an algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this hardware device.
§ 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.