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Pica Whole-Body MRI System 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. Hybrid Pica may also be used for imaging during interventional procedures when performed with NMR 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, RE Transmission Coil, RE 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 NMR System (K093984), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.

The provided text describes a medical device, the Pica Whole-Body MRI System, and its 510(k) submission for substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested information regarding study methodology, sample sizes, ground truth establishment, or expert involvement.

The document states: "Safety and performance testing were conducted to validate and verify that the filing device, Hybrid Pica Whole-Body MRI. System met all design specifications and was substantially equivalent to the predicate device." This is a high-level statement and does not provide the specifics requested in your prompt.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

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 for the test set: Not stated.
• Data provenance: Not stated.

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 stated.
• Qualifications of experts: Not stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication method: Not stated.

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 comparative effectiveness study: Not mentioned. The device is an MRI system, not an AI-assisted diagnostic tool in the context described.
• Effect size of human reader improvement with AI: Not applicable, as no AI assistance is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone algorithm performance: Not applicable. The device is a diagnostic imaging system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of ground truth: Not stated. The assessment focused on "design specifications" and "substantial equivalence to the predicate device" (K093984), implying technical and performance comparison rather than clinical outcomes against a pathology or expert consensus ground truth.

8. The sample size for the training set:

• Sample size for the training set: Not applicable to an MRI system described as a hardware and software upgrade to a predicate device, rather than an AI/ML algorithm requiring a training set in the conventional sense.

9. How the ground truth for the training set was established:

• How ground truth for the training set was established: Not applicable.

Summary of what is available:

• Device Name: Pica Whole-Body MRI System TMS-MRI-3500WB-02
• Predicate Device: Pica Whole Body MRI System TMS-MRI-3500WB-01 (K093984)
• Conclusion of Testing: "Safety and performance testing were conducted to validate and verify that the filing device, Hybrid Pica Whole-Body MRI. System met all design specifications and was substantially equivalent to the predicate device."

Missing Information:
The document lacks the detailed performance study information, including specific acceptance criteria, quantitative results, sample sizes, ground truth methodology, and expert involvement, that would be required to fully answer your prompt. This type of detail is often found in the actual testing reports or clinical study summaries, which are not part of this 510(k) summary letter.

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