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Mona - Orthopedic 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 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.

Mona - Orthopedic MRI System is a 0.2T 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 aninteractive program with user friendly interface.

The provided text describes an Abbreviated 510(k) Report for the MONA MRI system.

Here's an analysis of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets (e.g., specific signal-to-noise ratios, image resolution metrics, or diagnostic accuracy thresholds). Instead, it states a general performance goal for the device:

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing including clinical and laboratory testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the clinical data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for any clinical test set. The intended use states "These images when interpreted by a trained physician yield information that may assist in diagnosis," implying interpretation by medical professionals, but specifics are missing.

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

The document does not specify any adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study nor any effect size of human readers with vs. without AI assistance. The device in question is an MRI system, not an AI-powered diagnostic tool, so such a study would not typically be part of its clearance process in 2009.

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

The device is an MRI system, which is a diagnostic imaging device. Its function is to produce images for human interpretation. Therefore, a "standalone algorithm only" performance study in the context of AI would not be relevant or performed for this type of medical device in 2009. The document only refers to the system meeting design specifications and being substantially equivalent to a predicate.

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

The document does not specify the type of ground truth used for any clinical testing. It only generally states that testing was done to ensure the device met specifications and was substantially equivalent. For an MRI system, general ground truth would relate to image quality (e.g., resolution, contrast, artifact levels) and the ability to visualize anatomical structures, typically established by physicists, engineers, and clinical radiologists.

8. The sample size for the training set:

The document does not provide any information about a training set size. This is consistent with the device being an MRI system rather than an AI/ML algorithm that requires a training set.

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

Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable and not provided.

Summary of available information:

The provided 510(k) summary focuses on demonstrating that the Mona - Orthopedic MRI System is "substantially equivalent" to a predicate device (mStar MPF4500) and complies with relevant international and national standards. It broadly states that "performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device... met all design specifications." However, it lacks specific details regarding the methodology, sample sizes, ground truth establishment, or expert involvement for any clinical or performance studies. This level of detail is typical for 510(k) summaries for devices cleared prior to the more recent emphasis on detailed AI/ML performance evaluations and statistical rigor in some device categories.

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