(90 days)
PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical imaging and spectroscopy package which acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array coils. PROSE option can be used in conjunction with a Magnetic Resonance Scanner to permit non-invasive acquisition of high resolution images and spectral information about relative concentrations of metabolites of prostate gland that can be interpreted by a trained physician, and yield information that may assist in diagnosis of prostate diseases.
PROSE is a version of the PRESS (Point RESolved Spectroscopy), "double" spin echo pulse sequence that uses a 90° and two slice selective refocusing RF pulses to generate a spin echo from a localized volume. PROSE utilizes the standard Graphic Prescription tools and one or more sets of localizer images to determine the size and location of the spectroscopic volume.
The provided document is a 510(k) summary for the PROstate Spectroscopy and imaging Exam (PROSE) software option. It primarily focuses on demonstrating substantial equivalence to a predicate device and safety, rather than providing detailed performance acceptance criteria and a study proving those criteria.
Therefore, many of the requested sections about specific performance metrics and study details cannot be fully answered from the given text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative performance metrics for PROSE. The document mainly focuses on safety and substantial equivalence to a predicate device. | "Evaluation testing was done to verify the performance of the option in the clinical environment." (No specific results or metrics are provided). |
Explanation: The document states that "Evaluation testing was done to verify the performance of the option in the clinical environment," but it does not specify what performance metrics were evaluated or what the acceptance criteria for those metrics were. It does not provide any numerical results to report against acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified. The document mentions "interpreted by a trained physician," but this is for clinical use, not for establishing ground truth in a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not specified.
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 done: Not mentioned.
- Effect size of human reader improvement: Not applicable, as no such study is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study done: Not mentioned. The device is described as "clinical imaging and spectroscopy package... can be interpreted by a trained physician," implying human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not specified.
8. The sample size for the training set
- Training set sample size: Not specified. The document does not describe a machine learning model that would typically have a separate training set. It describes a software option for an MR scanner.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as no training set is described.
Summary of available information:
The document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems PROBE software option, K930265) and ensuring safety.
- Key points mentioned:
- PROSE is a software option for GE Magnetic Resonance Scanners.
- It's an image-guided, clinical imaging and spectroscopy package for the prostate gland.
- It acquires high-resolution anatomical images, volume-localized, water/lipid suppressed hydrogen spectra, and/or multi-voxel spectroscopic images.
- It uses an endo-rectal coil with phased-array coils.
- The information can be interpreted by a trained physician to assist in diagnosing prostate diseases.
- It was evaluated for safety according to IEC 601-2-33.
- Evaluation testing was done to verify performance in the clinical environment, but no specific performance data or acceptance criteria are provided.
- The manufacturer concludes it "does not result in any new potential hazards."
§ 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.