(63 days)
The PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints.
The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin When interpreted by a trained physician, these images provide relaxation time (T2), and flow. information that can be useful in diagnosis determination.
- Head, Body, Spine, Extremities Anatomical Region: Nucleus excited: Proton Diagnostic uses:
- Diagnostic uses:
2D T1- / T2-weighted imaging T1. T2, proton density measurements MR Angiography image processing
- Imaging capabilities:
- 2D, 3D Spin Echo (SE)
- 2D, 3D Fast Spin Echo (FSE)
- 2D Inversion Recovery (IR)
- 2D. 3D Fast Inversion Recovery (FIR)
- 2D,3D Gradient Echo (GE)
- 2D, 3D Steady state acquisition with rewinded GE (SARGE)
- 2D, 3D RF-spoiled SARGE (RSSG)
- 2D, 3D Time-reversed SARGE (TRSG)
MR Angiography (half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
- 2D, 3D TOF
- 2D, 3D TOF RSSG
- ECG, Peripheral Gating
- RF Coil Uniformity
Adaptive Image post-processing
ACR/NEMA/DICOM 3 compliant
- Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.
The AIRIS and AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by one additional RF Coil (PA/QD Shoulder Coil) to increase the clinical utility of the AIRIS and AIRIS II in the stationary configuration. The Shoulder Coil can operate either in the quadrature mode or in the phased array mode with the AIRIS II, and in the quadrature mode only with the AIRIS. The coil is available in Large and Standard sizes for both MRI systems, to accommodate a wide variety of physical patient sizes, and to achieve maximal coil filling factors.
The provided document is a 510(k) Summary for a new RF Coil (PA/QD Shoulder Coil) for existing MRI systems (AIRIS and AIRIS II). This submission is for an enhancement to an already cleared device, primarily adding a new accessory. Therefore, the document does not contain a comprehensive clinical study with acceptance criteria and performance metrics in the way one would expect for a novel diagnostic algorithm or a new primary imaging modality.
Instead, the submission focuses on demonstrating substantial equivalence to the predicate device, meaning it asserts that the new coil performs similarly and introduces no new safety or effectiveness concerns. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate MRI systems and the ability of the new coil to function within those established parameters.
Here's an attempt to answer your questions based on the provided text, acknowledging the limitations of a 510(k) for an accessory:
Acceptance Criteria and Device Performance Study for the PA/QD Shoulder Coil
As this 510(k) submission (K992650) is for an additional RF Coil (PA/QD Shoulder Coil) for existing, cleared MRI systems (Hitachi AIRIS and AIRIS II), the "acceptance criteria" and "study" described are focused on demonstrating that the new coil functions as intended within the established safety and performance envelope of the predicate devices. The submission emphasizes substantial equivalence to the predicate MRI systems and their existing coils, rather than a de novo clinical trial with specific diagnostic performance metrics.
The implicit acceptance criteria are that the new shoulder coil allows the AIRIS and AIRIS II systems to continue to produce high-quality diagnostic images of the shoulder joint, consistent with the performance of the predicate devices for other anatomical regions or with previous coils. The performance is "proven" through the assertion that the device's technological characteristics are identical to the predicate device in terms of fundamental MR physics and imaging capabilities, and that the new coil enhances clinical utility without altering the core functional mechanism or safety profile.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Description (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Image Quality & Functionality | The PA/QD Shoulder Coil, when used with AIRIS/AIRIS II, produces diagnostic quality images of the shoulder articular anatomy and other large joints, consistent with the intended use of the MR system. This implies sufficient signal-to-noise ratio, resolution, and artifact suppression for clinical diagnosis. | "The PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints." "The AIRIS and AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by one additional RF Coil (PA/QD Shoulder Coil) to increase the clinical utility of the AIRIS and AIRIS II in the stationary configuration." The document implies that the coil functions as expected to deliver images with the same diagnostic capabilities and characteristics as the predicate system for the specified anatomical region. |
| Technological Equivalence | The fundamental scientific principles, physical and performance characteristics, imaging capabilities, and operation with MR systems are identical or substantially equivalent to the predicate MRI systems and their existing coils. | "DEVICE TECHNOLOGICAL CHARACTERISTICS: Identical to the Predicate Device." "AIRIS and AIRIS II software did not need to be revised in order to support full functionality of this PA/QD Shoulder Coil." This confirms that the new coil operates within the established technical framework. "MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure..." |
| Safety | The addition of the PA/QD Shoulder Coil does not introduce new safety concerns (e.g., related to SAR, heating, or magnetic field interactions) beyond those already characterized for the predicate MRI system. | While not explicitly stated as "safety results," the fact that the submission states "PRODUCT/TECHNOLOGICAL CHARACTERISTICS Identical to the Predicate Device." and received FDA clearance without specified safety concerns implies that safety was deemed equivalent to the predicate. RF Coil Uniformity is listed as an imaging capability, which contributes to image quality and implicitly to safe operation. |
| Intended Use | The coil performs within the defined intended uses for the AIRIS/AIRIS II MR system. | The "Indications for Use" section explicitly states: "The PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints." The overall intended use of the MR system ("to provide the physician with physiological and clinical information... useful in diagnosis determination") remains unchanged and is extended to the shoulder via this coil. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical "test set" or a formal clinical study with patient data in the realm of diagnostic performance. For an accessory like an RF coil, "testing" would typically involve engineering verification and validation (e.g., phantom imaging, signal-to-noise measurements, image uniformity, SAR testing) to ensure it meets technical specifications and functions correctly with the existing MRI system. Such technical data is not detailed in this 510(k) summary, which is a high-level overview. There is no mention of country of origin or retrospective/prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical "test set" and corresponding ground truth determination are described, there is no mention of experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is described.
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
Not applicable. This submission is for an MRI coil, not an AI-powered diagnostic tool, and no MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for an MRI coil, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical ground truth determination is described in this summary. The "ground truth" for an MRI coil would be its ability to accurately reflect the NMR properties of the tissue it images, which is assessed through technical performance and image quality.
8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is mentioned.
§ 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.