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510(k) Data Aggregation
(75 days)
The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.
The provided text is a 510(k) summary for the Paramed Mr Inspire MRI system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, much of the requested information cannot be extracted directly from this document because the regulatory pathway for this device is based on substantial equivalence to existing devices, not on proving explicit performance against pre-defined clinical acceptance criteria like those expected for novel diagnostic algorithms.
Here's a breakdown of what can be inferred or is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting pathologies) for the Mr Inspire. Instead, it compares technical parameters to its predicate device, the MrJ. The implicit acceptance criterion is that the technical parameters and image quality are equivalent or better than the predicate device.
| Parameter (from document) | Mr Inspire Reported Performance | Acceptance Criteria (Implied: Equivalent to predicate MrJ) |
|---|---|---|
| Magnetic field strength | 0.22 T | 0.22 T |
| Stray field 5G | maximum 80 cm from magnet covers | maximum 80 cm from magnet covers |
| Weight | 4200 Kg | 4200 Kg |
| Homogeneity | < 5 ppm over 20 cm DSV (FWHM) | < 5 ppm over 20 cm DSV (FWHM) |
| SAR (Head worst case) | 0.57 +/- 0.15 W/Kg | (Not explicitly listed for MrJ, but implied comparable) |
| dB/dt | 19.8 T/s with τ = 600 µs Gradient coil diameter 850 mm | (Not explicitly listed for MrJ, but implied comparable) |
| FOV | up to 220 mm visualized FOV | up to 220 mm visualized FOV |
| Gradient maximum theoretic strength | ± 20 mT/m | ± 20 mT/m |
| Gradient maximum clinically employed strength | ± 15 mT/m | ± 15 mT/m |
| Slew rate | 30 mT/m/ms | 30 mT/m/ms |
| Image quality (phantom and volunteer) | Acceptable SNR and image quality | Equivalent to predicate MrJ |
| Safety (fire preventing materials) | Safer | Equivalent to or safer than predicate MrJ |
| New Knee coil | Equivalent to standard cleared knee coil but wider | Clinical output documented in "Validation activities" |
| Three new linear coils | Can be employed for cleared anatomies, flexible | Clinical output documented in "Validation activities" |
2. Sample size used for the test set and the data provenance
- Test Set: The document mentions "test images performed both on phantoms and on healthy volunteers" for the Mr Inspire device.
- Sample Size: The exact number of phantoms and healthy volunteers used is not specified.
- Data Provenance: The country of origin for this data is not specified, but the manufacturer is based in Italy. The study is considered prospective in the sense that these tests were performed with the new device prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document states that images can "yield information that can be useful in the determination of a diagnosis" when "interpreted by a trained physician" and "diagnostically useful information" if "interpreted by a medical expert."
- However, it does not specify the number or qualifications of experts used to establish ground truth for the "test images performed on phantoms and healthy volunteers." The evaluation likely revolved around technical image quality parameters rather than a diagnostic performance study requiring expert consensus on pathologies.
4. Adjudication method for the test set
- Not applicable / Not specified. The document does not describe a diagnostic study requiring an adjudication method. The evaluation mentioned is related to technical performance (SNR, image quality) and safety.
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. This device is an MRI hardware system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an MRI hardware system, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "test images performed on phantoms and healthy volunteers," the ground truth for phantoms is derived from their known physical properties. For healthy volunteers, the "ground truth" is their healthy state, evaluated for image quality and technical compliance rather than diagnostic accuracy for a specific pathology. There's no mention of expert consensus, pathology, or outcomes data being used to establish ground truth in the context of a diagnostic performance study.
8. The sample size for the training set
- Not applicable. This document describes an MRI hardware system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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