(81 days)
The MR-NVC-150N, RAPID Neurovascular (NV) Attachment Coil is a receive-only multiple array device used for MRI imaging of the upper spine and torso. It is designed to be used the Hitachi Echelon 1.5T MRI system.
The MR-RWC-150N, RAPID Small Extremity Coil is a receive-only multiple array device used for MRI imaging of the extremities. It is designed to be used the Hitachi Echelon 1.5T MRI system.
The MR-NVC-150N, ECHELON RAPID Neurovascular Attachment Coil is a receive-only multiple array device used for MRI imaging of the upper spine and torso.
The MR-RWC-150N. ECHELON RAPID Small Extremity Coil is a receive-only multiple arrav device used for MRI imaging of the extremities.
The provided text describes a 510(k) summary for MRI coils. Based on the document, here's an analysis of the acceptance criteria and the "study" that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or report specific device performance metrics in comparison to such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, stating that the new coils function similarly to the predicate devices and produce images that provide information useful for diagnosis when interpreted by a trained physician.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified in the document | Not specified in the document |
| Function for MRI imaging | "receive-only multiple array device used for MRI imaging of the upper spine and torso" (MR-NVC-150N) |
| Function for MRI imaging | "receive-only multiple array device used for MRI imaging of the extremities" (MR-RWC-150N) |
| Compatibility | "designed to be used [with] the Hitachi Echelon 1.5T MRI system" |
| Signal processing | "The signal output of each element is independently processed by the MRI system to enhance performance." |
| Safety | Implied by substantial equivalence to legally marketed predicate devices and compliance with general controls provisions of the Act. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific clinical test set or study with a defined sample size for the new devices (MR-NVC-150N and MR-RWC-150N).
The primary method of demonstrating acceptance is through substantial equivalence to predicate devices (ECHELON RAPID Foot Coil and possibly ECHELON RAPID Small Extremity Coil, though the latter is also a new device in the same submission). This means the manufacturer is asserting that the new devices share fundamental scientific technology and intended use with already-cleared devices, implying that their performance and safety would be comparable. No information is provided regarding data provenance (country of origin, retrospective/prospective) for any specific testing of these devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Since there is no description of a dedicated clinical test set with ground truth established, this information is not applicable or provided in the document. The claim of "useful in diagnosis determination" relies on the general understanding of MRI technology and the assumption that qualified physicians would interpret images produced by these coils, similar to predicate devices.
4. Adjudication Method for the Test Set:
As no specific test set requiring ground truth adjudication is described, this information is not applicable or provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention or describe an MRMC comparative effectiveness study, nor does it discuss any effect size of AI assistance (as AI is not explicitly part of the device's main function here). This submission is for MRI coils, which are hardware components, not software algorithms for image interpretation or enhancement in the AI sense.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The concept of a "standalone" algorithm performance study is not applicable here. The devices are MRI coils, which are physical components of an MRI system and do not operate as standalone algorithms. Their performance is inherently tied to the MR system and subsequent human interpretation.
7. Type of Ground Truth Used:
No specific ground truth (like pathology, expert consensus, or outcomes data) is mentioned as being used to evaluate the new coils directly. The basis for acceptance is substantial equivalence to predicate devices that are already cleared for providing diagnostically useful images.
8. Sample Size for the Training Set:
The document does not describe a training set for the new devices. This is consistent with the nature of the device (MRI coils) and the regulatory pathway (510(k) based on substantial equivalence), which typically doesn't involve training data in the algorithmic sense.
9. How the Ground Truth for the Training Set Was Established:
As no training set is described, this information is not applicable or provided.
§ 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.