(33 days)
The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints.
The TT1 General Purpose Coil is a linear receive-only coil for operation at a magnetic field strength of 1.5T with the GE Signa® 1.5T system. The coil is a single element coil consisting of a 3-inch diameter loop. Coupling of the coil to the transmitted field is prevented through an active blocking circuit.
The TT1 General Purpose Coil is specially designed for MR imaging of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints. The coil provides optimum signal to noise ratio and coverage, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately a 10 cm Field of View.
The TT1 General Purpose Coil is a magnetic resonance diagnostic device (a receive-only MR imaging coil) intended for use at 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of small-to-medium sized anatomical regions.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints. |
| Dimensions | Coil length - 3 inches, Coil width - 3 inches. Similar in weight to the predicate GE 3-inch General Purpose Coil. |
| Coil Architecture | Linear/Single channel receive-only for 1.5T operation. Housing Type - ABS plastic. Primary Decoupling - Active/PIN diode-enabled blocking circuitry. |
| Performance (SNR & Coverage) | Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 10 cm Field of View. This is stated to be substantially equivalent to the predicate GE 3-inch General Purpose Coil which also has "Optimal Signal to Noise Ratio (SNR) and coverage and high resolution imaging". The other predicate, MRgFUS, has a 15 cm Field of View. |
| Safety | Compliance with IEC 60601-1 (medical electrical equipment safety), UL 94 (flammability of plastic materials), and NEMA MS-6 (characterization of special purpose coils for diagnostic MR images). A risk assessment (FMEA) was conducted. |
| Principles of Operation | Hydrogen nuclei excitation for imaging of the scanned organ. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Side by side comparison testing was conducted with the predicate device, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance." However, the exact sample size used for the test set (number of images, patients, or anatomical regions) is not specified.
The data provenance is also not explicitly stated. It is implied that the testing was conducted by the applicant, Tursiop Technologies, L.L.C., using their device and a commercially available predicate. Whether this involved human subjects, phantoms, or retrospective data is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The study appears to be a technical comparison of coil performance (e.g., SNR, image quality) rather than a clinical study requiring expert interpretation of medical images for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the device (an MR coil), an adjudication method for establishing ground truth in a diagnostic context is not directly applicable to the described performance testing. The comparison is focused on technical equivalence.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted and is not relevant for this type of device submission. This submission focuses on the technical equivalence of an MR coil to existing predicate devices, not on the improvement of human reader performance with AI assistance.
6. Standalone Performance:
The "standalone performance" of the device, in terms of its ability to acquire images, is inherently what was tested. The document states that the TT1 General Purpose Coil demonstrated "substantially equivalent performance" in side-by-side comparison testing with a predicate device. This implies that the device, on its own (as a coil), met the expected performance characteristics for an MR imaging coil. There isn't a separate "algorithm only" component for this hardware device.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by comparison to a predicate device (the GE 3-inch General Purpose Coil) through "side by side comparison testing." This implies that the performance metrics (e.g., SNR, image quality, coverage) achieved by the TT1 coil were directly compared to those of the predicate. This is a form of technical equivalence ground truth rather than a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set:
This information is not applicable as the TT1 General Purpose Coil is a hardware device (an MR coil) and does not involve AI or machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is 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.