(90 days)
Pica Whole Body MRI System, TMS-MRI-3500WB-01, is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
It may be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Pica Whole Body MRI System is a 0.35T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP Professional is an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body MRI System (K091580), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.
The provided text is a 510(k) Summary for a Pica Whole Body MRI System. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain any information about acceptance criteria, device performance, sample sizes used for testing, ground truth establishment, or clinical study results in the manner requested.
Specifically, the document states: "Performance testing was conducted to validate and verify that the proposed device, Pica Whole Body MRI System met all design specifications and was substantially equivalent to the predicate device." It also mentions "modifications" to the existing and cleared Pica Whole Body MRI System (K091580) in Magnet (Static Field Strength), Appearance, Receive Coil, and some specifications.
Without further documentation, it's impossible to answer the specific questions about acceptance criteria and study details. This 510(k) summary is a high-level overview and does not delve into the detailed performance data or study methodology.
Therefore, for each point requested:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The text only states that performance testing was conducted to meet "all design specifications" and demonstrate "substantial equivalence," but no specific criteria or performance metrics are listed.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document does not mention any sample sizes, data provenance, or study design (retrospective/prospective).
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)
- Not available in the provided text. The document does not describe the establishment of ground truth or the involvement of experts for any test sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text. No information about adjudication methods is 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
- Not applicable / Not available in the provided text. This device is an MRI system, not an AI-powered diagnostic tool for image interpretation. Therefore, a MRMC comparative effectiveness study comparing human readers with AI assistance would not be relevant for this type of submission. The document focuses on the hardware and basic functionality of the MRI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not available in the provided text. As this is an MRI system, standalone algorithm performance in the context of AI is not relevant. The device's performance relates to image acquisition quality, field strength, and other physical/technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the provided text. Ground truth information is not provided. For an MRI system, ground truth might relate to image quality metrics, object visibility, or signal-to-noise ratios, often established through phantom studies or comparison with accepted reference standards, but these details are not in the document.
8. The sample size for the training set
- Not applicable / Not available in the provided text. This is an MRI hardware system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable / Not available in the provided text. See point 8.
§ 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.