(175 days)
General disease of the TMJs
Magnetic Resonance Device Accessory - Bilateral TMJ Coil
This device is a Magnetic Resonance Device Accessory - Bilateral TMJ Coil. The submission primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and performance data in a dedicated study.
Here's an analysis based on the provided text, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the new Flexart™ Bilateral TMJ Coil in the form of a table to be met by a study. Instead, it compares the new coil to existing cleared devices based on several parameters. The "performance" reported is largely in the context of similarity to these predicate devices.
| Parameter | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Flexart™ Bilateral TMJ Coil) |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | Similar to K933018 (100mm surface coil) and K943021 (MRT-150A Bilateral TMJ Coil) | Transaxial: 167 |
| Coronal: 154 | ||
| Sagittal: 224 (These are absolute numbers, implying the new coil meets or is similar to expectations) | ||
| Attachment Schemes | Similar to predicate devices | Similar to predicate devices |
| Tuning and Detuning Schemes | Similar to predicate devices | Similar to predicate devices |
| Safety Parameters | Similar to predicate devices (K933018 & K943021) | Not changed from Flexart™ system (K933018) |
| Manufacturing Methodology | Unchanged from Flexart™ system | Unchanged from Flexart™ system |
| Software Verification/Validation | Unchanged from Flexart™ system | Unchanged from Flexart™ system |
| Patient Contact Materials | Same as previously cleared Toshiba coils | Same as previously cleared Toshiba coils |
| Maximum Static Field Strength | 0.5 Tesla | 0.5 Tesla |
| Rate of Change of Magnet Field | 6.97 T/s axial, 10.64 T/s transverse (> 700 microseconds) | 6.97 T/s axial, 10.64 T/s transverse (> 700 microseconds) |
| Radiofrequency Power Deposition | 0.256 W/kg | 0.256 W/kg |
| Acoustic Noise Levels | 89.5 - 94.5 Typical | 89.5 - 94.5 Typical |
| Uniformity | Unchanged | Unchanged |
| Geometric Distortion | Unchanged | Unchanged |
| Slice profile | Unchanged | Unchanged |
| Slice thickness | Unchanged | Unchanged |
| Interslice spacing | Unchanged | Unchanged |
Study Proving Acceptance Criteria:
The document describes a substantial equivalence summary, not a dedicated study with a formal acceptance criteria section and a detailed statistical analysis against those criteria. The "study" here is essentially a comparison of the new Flexart™ Bilateral TMJ Coil against its predicate devices (100mm surface coil cleared with Flexart™ K933018 and MRT-150A Bilateral TMJ Coil cleared in K943021).
The text states: "The coils share similar Signal-to-Noise ratios, attachment schemes, tuning and detuning schemes and safety parameters. The Flexart " Bilateral TMJ Coil does not change the previously cleared safety parameters of the Flexart" system." This implies that the performance of the new coil was measured and found to be "similar" or "unchanged" from the predicate devices, which are presumed to have already met their respective performance and safety standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document does not mention a specific "test set" of patients or scans used for independent validation of the new coil's performance. The SNR values (Transaxial: 167, Coronal: 154, Sagittal: 224) are presented as "typical," suggesting they are derived from internal measurements or specifications, not necessarily a formal clinical test set designed for regulatory submission.
- Data Provenance: Not specified. Given the nature of a 510(k) summary focused on substantial equivalence for a coil accessory, it's highly likely any comparative data or measurements would be internal laboratory or engineering data, rather than a prospective clinical study involving human subjects. The country of origin of such internal testing data is not mentioned but would presumably be associated with the submitter, Toshiba America MRI, Inc.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This type of device (an MRI coil) does not typically involve human expert interpretation of images for its performance validation in a 510(k) submission. Its performance is assessed through technical imaging parameters (SNR, uniformity, etc.), which are objectively measurable by engineering or physics standards.
4. Adjudication Method for the Test Set:
Not applicable. As there is no "test set" relying on human interpretation, no adjudication method is mentioned or required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study assesses human reader performance, often with and without AI assistance, which is not relevant for the regulatory review of a physical MRI coil accessory like this one.
6. Standalone (Algorithm Only) Performance:
No, this is not applicable. The device is a physical MRI coil, not an algorithm or software. Therefore, there's no "algorithm only" performance to report.
7. Type of Ground Truth Used:
The "ground truth" for the performance characteristics (e.g., SNR, uniformity, geometric distortion) would be the physical and technical specifications and measurements typically performed in an MRI laboratory setting according to established industry standards or internal validation protocols. For safety parameters, the ground truth is established regulatory limits and measurements proving compliance.
8. Sample Size for the Training Set:
Not applicable. The device is a passive MRI coil. It does not involve a "training set" in the context of machine learning or AI algorithms.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.