(224 days)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
The changes performed to G-scan Brio, with respect to the cleared version – G-scan Brio K133490 – are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- A new Bilateral TMJ Coil
- Introduction of the DPA Lumbar spine coil n° 10 with a new extra-large flexible section
- Introduction of the thoracic spine section examination
- A new software version including the following features:
- o Customization of Image Enhancement
- o Overlay sending to PACS
- o Isotropic 3D acquisition
The provided document is a 510(k) summary for the G-scan Brio, a Magnetic Resonance (MR) system. It describes modifications made to an already cleared device (K133490) to improve system performance.
Based on the content, the document explicitly states that "No clinical tests were performed." This means there is no study described within this document that demonstrates the device meets acceptance criteria through clinical performance.
Therefore, most of the requested information cannot be provided from this particular document.
Here's what can be inferred or stated based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The submission focuses on adherence to safety standards and technical characteristic equivalence.
- Reported Device Performance: No clinical performance metrics are reported as no clinical tests were performed. The device's "performance" is demonstrated through non-clinical testing for compliance with safety and performance standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable, as no clinical tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical tests were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical tests were performed.
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
- No MRMC study was done, as no clinical tests were performed. The device described is an MR system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study was done, as no clinical tests were performed. The device is a diagnostic imaging system, designed to be interpreted by medical experts.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical tests were performed.
8. The sample size for the training set
- Not applicable, as no clinical tests were performed.
9. How the ground truth for the training set was established
- Not applicable, as no clinical tests were performed.
Summary of Non-Clinical Tests (as provided in the document):
The document details that the G-scan Brio was evaluated through non-clinical tests to demonstrate substantial equivalence to its predicate device. These tests focused on:
- Medical electrical equipment safety
- Risk management
- Software verification
- Image quality
The device was found to conform to the following medical device safety standards:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-33
- ISO 14971
- ISO 62304
- IEC 62366
- NEMA MS-1
- NEMA MS-3
The conclusion states that "The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices to applicable medical device safety and performance standards."
In essence, the device's acceptance criteria in this submission are met by demonstrating compliance with recognized safety and performance standards through non-clinical testing, rather than through a clinical performance study.
§ 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.