(167 days)
The Hitachi Oasis MRI with Spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
This package is indicated for use as follows:
Anatomical Region: Head, whole body Nuclei Excited: "H
MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.
The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".
The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hitachi Oasis MRI with Spectroscopy:
Device: Oasis MRI with Spectroscopy
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness is identical to the predicate device. | The submitter states: "The safety and effectiveness of this MR Spectroscopy Package is identical to the predicate device. The addition of this package does not impact the safety and effectiveness of the Oasis MRI system (K072279)." |
| Intended Use is identical to the listed predicate device. | The submitter states: "The intended use is identical to the listed predicate device." |
| Provides information based on relative concentrations of metabolites in body tissues. | The device is described as providing "information based on relative concentrations of metabolites in body tissues." |
| NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. | The device is described as providing "NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift." |
| Spectral data, when interpreted by a trained medical practitioner, provides information useful in diagnosis determination. | It is stated that "When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination." |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a separate test set, its sample size, or the provenance of any data used for a performance study. The submission relies on substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The basis for approval is substantial equivalence to a predicate device, not a head-to-head comparison demonstrating improved human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of the algorithm without human-in-the-loop performance was not performed or reported in this submission. The document describes the system as a diagnostic device where the spectral data is "interpreted by a trained medical practitioner."
7. Type of Ground Truth Used
The concept of a "ground truth" for a performance study is not directly applicable or mentioned in this submission, as the basis for approval is substantial equivalence to a predicate device rather than a de novo clinical performance study against a defined ground truth. The device's utility is described as providing information useful in diagnosis when interpreted by a medical practitioner.
8. Sample Size for the Training Set
This information is not provided. The submission does not describe the development or training of new algorithms for which a training set would be required. It focuses on the capabilities of the spectroscopy package using existing MR hardware and software.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this substantial equivalence submission.
§ 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.