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Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.

Model 1300GE-64 - Pediatric Positioner. Compatible with GE Signa 1.5T MRI Systems. MRI Accessory.

The provided text describes a 510(k) summary for the "Model 1300GE-64 - Pediatric Positioner." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through safety and imaging performance parameter comparisons. It does not describe a study performed to establish acceptance criteria for the device itself or analyze its diagnostic performance.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (beyond "no change" relative to predicate).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size.
• Standalone performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

Based on the provided text, the device is a "Pediatric Positioner" intended for use with a GE Signa 1.5T MRI System. The "study" described is essentially a comparison to legally marketed predicate devices to establish substantial equivalence concerning safety and imaging performance.

Here's an analysis of what can be extracted or inferred:

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

The acceptance criteria are implicitly that the device should not change the performance or safety parameters of the MRI system when compared to using legally marketed predicate devices.

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

• Sample Size: Not applicable/not provided. This is a comparison to predicate devices' specifications, not a study involving a test dataset of patient images.
• Data Provenance: Not applicable/not provided.

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

• Not applicable. Ground truth for diagnostic performance is not established as this is a device accessory comparison.

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

• Not applicable.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a passive pediatric positioner, not an AI or diagnostic imaging algorithm.

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

• Not applicable. This is a passive medical device accessory, not an algorithm.

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

• Not applicable for diagnostic performance. The "ground truth" for this submission is the established safety and performance parameters of the GE Signa 1.5T MRI System when used with legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm.

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

• Not applicable. This is not an AI/algorithm.

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