(99 days)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging the head, 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 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.
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, 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 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.
S-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 change performed on the modified G-scan Brio, with respect to the cleared version - G-scan Brio K142421 - are due to the improvement of the system performance. This modification is for the introduction of the new Shoulder Coil 20 code 130000014 (already cleared with S-scan K161238), the Head Coil 16 code 13000100, and the head indication for use.
The change performed on the modified S-scan, with respect to the cleared version – S-scan K161238 – are due to the improvement of the system performance. This modification is the introduction of the new Head Coil 16 code 13000100 and the head indication for use.
The provided text describes a 510(k) premarket notification for the G-scan Brio and S-scan Magnetic Resonance (MR) systems. It confirms FDA clearance for these devices due to their substantial equivalence to legally marketed predicate devices.
However, the document does not contain information regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, details of multi-reader multi-case studies or standalone algorithm performance, or the specific type of ground truth used outside of general "diagnostically useful information."
The document primarily focuses on:
- Regulatory Clearance: Affirming that the devices are substantially equivalent to predicates.
- Device Description and Intended Use: Outlining what the MR systems image (head, limbs, joints, spinal column) and how they function.
- Technological Characteristics: Describing the changes made (new coils for shoulder and head imaging) and stating they do not alter the core technology.
- Non-Clinical Tests: Listing adherence to various safety and performance standards (e.g., IEC, ISO, NEMA).
- Clinical Tests (briefly mentioned): Stating that "sample clinical images and attestation from a U.S. Board-Certified Diagnostic Radiologist that the images are of good diagnostic quality were provided."
Therefore, it is not possible to provide the requested information in the format of acceptance criteria and proven device performance based on the provided document. The document states that the devices are "as safe, as effective, and performs as well as or better than the predicate" based on non-clinical testing and general attestations about image quality, but it does not quantify these claims or provide the specific details of a performance study as outlined in your request.
§ 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.