(75 days)
The Picker MR Spectroscopy Package 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 making a diagnosis.
This package is indicated for use as follows:
Anatomical region: Head, whole body
Nuclei Excited: 1H
Picker's MR Spectroscopy Package described in this submission is a proton ('H) spectroscopy software option. The package includes both capabilities for single voxel proton (SVP) spectroscopy and chemical shift imaging (CSI). These techniques provide a non-invasive method for analyzing metabolite concentrations in the brain and throughout the body. The MR Spectroscopy Package does not include any additional risks to the patient other than those for standard MR imaging.
The provided document is a 510(k) premarket notification for the Picker MR Spectroscopy Package. It asserts substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with quantitative performance metrics. Therefore, many of the requested sections (e.g., sample sizes, ground truth establishment, MRMC studies) are not applicable as they would be for an AI/ML-based device seeking de novo authorization or a device with new performance claims.
Here's a breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of quantitative performance thresholds for a novel device. Instead, it demonstrates substantial equivalence to legally marketed predicate devices by comparing various technological characteristics and intended uses. The "performance" reported is essentially the device's feature set and capabilities, shown to be similar to the predicates.
| Parameter | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Picker MR Spectroscopy Option) |
|---|---|---|
| Nucleus | Proton (as per predicate devices) | Proton |
| Type of Spectroscopy | Single Voxel and Chemical Shift Imaging | Single Voxel and Chemical Shift Imaging |
| Spectroscopic Hardware | Phantom for QA | Phantom for QA |
| Shimming Technique | Automated | Automated |
| Solvent Suppression | Automated (e.g., CHESS) | Automated (MOIST, MOIST2, FATFREE, DUALSAT) |
| Localization Techniques | STEAM and PRESS | STEAM and PRESS |
| Voxel Positioning | Alphanumerical or Graphical Positioning | Graphical positioning |
| Minimum Voxel Size | 10 x 10 x 10 mm3 (as per predicate Siemens K951650) | 5 x 5 x 5 mm3 (Picker's is smaller, thus potentially better or equivalent for clinical utility) |
| Minimum TE | STEAM – 10ms, PRESS – 35ms (as per predicate GE K930265) | STEAM – 20ms, PRESS – 35 ms |
| Typical TR Range | 1.5 – 6 sec (as per predicate GE K930265) | 1.5 – 3 sec |
| Acquisition Time | Approximately 10 minutes (as per predicate GE K930265) | Approximately 3 – 7 minutes (Picker's is faster, thus potentially better or equivalent for clinical utility) |
| Post-processing Features | Zero filling, water reference, baseline/phase correction, FFT, apodization, curve fitting, peak info, labeling | Phase correction, filtering, data zeroing, retrospective voxel boundary shifting, FFT, baseline correction, peak fitting/analysis, chemical shift assignment, variable smoothing/differentiation |
| Key Metabolites | NAA, Cr/PCr, Cho, lipids, and others at short TEs | NAA, Cr, Cho, mI, Glx, and Lac |
| Data Display Options | Spectra, results of fit, images of metabolite distributions/ratios | Spectra, results of fit, images showing metabolite distributions or ratios |
| Output Type | Archived to database, various print/digital formats | Archived to database, film, post-script printer |
| Indications for Use | Similar to predicates (e.g., Brain, any anatomy with little fat) | Head, whole body |
| Intended Use | Non-invasive diagnostic device providing metabolite concentration information for diagnosis when interpreted by trained practitioner | Non-invasive diagnostic device providing metabolite concentration information for diagnosis when interpreted by trained practitioner |
Note on Acceptance Criteria: In this context, "acceptance criteria" is interpreted as demonstrating that the device's technical specifications and intended use are sufficiently similar to (or improved upon, while maintaining safety and effectiveness) those of already legally marketed predicate devices. The FDA's issuance of the 510(k) clearance acts as the "proof" that these criteria for substantial equivalence have been met.
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission asserting substantial equivalence based on a comparison of device specifications and intended use, not a clinical trial with a test set of patient data to measure performance against a quantitative endpoint.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert-established ground truth was part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was part of this 510(k) submission.
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. The device described is an MR Spectroscopy Package, a hardware/software option for an MRI system that provides spectral data, not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic tool that provides data for interpretation by a trained medical practitioner ("human-in-the-loop"), as stated in its intended use. It is not a standalone algorithm providing diagnoses without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this is a substantial equivalence claim for a diagnostic tool's specifications, there was no ground truth validation required for clinical performance in the manner an AI/ML algorithm would need.
8. The sample size for the training set
Not applicable. This device does not appear to involve machine learning models that would require a "training set" in the conventional sense. The submission focuses on the technical characteristics and intended use of the spectroscopy package.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.