(56 days)
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 OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use for the OASIS Specialty Coils are as follows:
- The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
- . The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
- The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
- The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.
The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.
This document, K073310, is a 510(k) premarket notification for several specialty magnetic resonance imaging (MRI) coils manufactured by Hitachi Medical Corporation. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.
The provided document describes the intended use and technological characteristics of the OASIS Specialty Coils (CTL Coil, QD Flexible Body Coils (L and XL), and Rapid Foot Coil) and asserts their substantial equivalence to predicate devices (ECHELON Whole Spine (CTL) Coil, ALTAIRE Flex Body (Large) Coil, ALTAIRE Flex Body (Extra Large) Coil, and OASIS RAPID Head Coil).
*However, the document does not contain any information regarding specific acceptance criteria, study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to device performance.
The document primarily focuses on:
- Device Identification: Naming the new devices and their predicate devices.
- Intended Use: Specifying the anatomical regions for which each coil is designed (cervical spine, thoracic spine, abdomen, foot).
- Device Description and Function: Briefly explaining that these are receive-only multiple array devices for obtaining diagnostic images with the OASIS MRI System.
- Scientific Concepts: A general overview of MRI principles.
- Physical and Performance Characteristics (General): Describes the number of elements in each coil and that signals are independently processed to enhance performance. It does not provide specific performance metrics or acceptance thresholds.
- Technological Characteristics: States they are similar to predicate devices.
- Conclusion: The submitter's opinion that the devices are substantially equivalent.
- FDA Response: The FDA's letter granting 510(k) clearance based on substantial equivalence to predicate devices.
Given the content of this 510(k) submission, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use matching predicate devices, rather than a clinical performance study with specific acceptance criteria and detailed results.
Therefore, for each point requested, the answer will be:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
Explanation: The document describes the technological characteristics and intended use of the coils, stating they are similar to predicate devices. It does not provide specific performance metrics or quantitative acceptance criteria that would typically be seen in a clinical performance study for image quality or diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the provided document.
- Data Provenance: Not specified in the provided document.
Explanation: The document does not describe a performance study with a test set of data. The submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than presenting a new clinical data set.
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)
- Number of Experts: Not applicable, as no test set requiring ground truth establishment is described.
- Qualifications of Experts: Not applicable.
Explanation: As no performance study with a test set is detailed, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no test set requiring ground truth establishment is described.
Explanation: Without a performance study or test set, adjudication methods are not relevant to the information provided.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not described.
- Effect Size: Not applicable.
Explanation: This device is a passive MRI coil, not an AI-powered diagnostic tool. The submission is for hardware (coils), and an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study was not described.
Explanation: This device is a passive MRI coil and does not involve an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described.
Explanation: Since no performance study to establish the device's diagnostic performance is detailed, no ground truth types are mentioned. The submission focuses on device characteristics and equivalence.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable, as no training set for an algorithm is described.
Explanation: This is a hardware submission, not an AI/algorithm submission, so the concept of a training set is not relevant here.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
Explanation: As no training set or algorithm is described, the method for establishing its ground truth is not relevant.
§ 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.