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The Indications for Use for the Mobile Siting option of Signa Profile System is the same as for a Fixed Site System. The Wrist Coil expands the capability of the Signa Profile System. It accommodates and improves imaging of the wrist and surrounding structures.

The Signa Profile System is identical for both the Mobile and Fixed Site options. The Wrist Coil option is a quadrature receive only coil. The coil comes with an adjustable positioning base and patient comfort pads for support. It is designed for use with a vertical magnetic field MR imaging system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Signa Profile Wrist Coil and Mobile Siting Options:

Unfortunately, the provided text does not contain sufficiently detailed information to fill out most of the requested fields. The summary of safety and effectiveness primarily focuses on establishing substantial equivalence to existing devices rather than presenting specifics of performance testing against explicit acceptance criteria.

Key Findings from the Document:

• The submission is for the Signa Profile Wrist Coil and Mobile Siting Options for the GE Signa Profile MR System.
• The manufacturer is GE Yokogawa Medical Systems, Ltd. (Japan).
• The primary argument for safety and effectiveness is substantial equivalence to the currently marketed Signa Profile System (software and electronics) and the Signa Profile Extremity Coil.
• "Summary of Studies" section states: "The Wrist Coil and a Mobile Sited Signa Profile System were evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Both options performed to stated specifications." This is the only mention of performance evaluation, but it lacks specific criteria or detailed results.

Inferences and Missing Information:

• Acceptance Criteria & Reported Performance: The document only vaguely states "performed to stated specifications" based on NEMA and IEC standards. The specific criteria (e.g., signal-to-noise ratio, field homogeneity, image uniformity, resolution) and the numerical results are not provided.
• Sample Size, Ground Truth, Adjudication, MRMC/Standalone Studies, Training Set: There is no mention of patient data, clinical studies, expert review, or any AI/algorithm component. This submission is for hardware (MRI coil, mobile siting) and its performance against engineering/safety standards, not diagnostic algorithm performance on medical images.

Detailed Breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criterion	Reported Device Performance
   General: Conformity to NEMA performance standards	"Performed to stated specifications"
   General: Conformity to IEC 601-1 International medical equipment safety standard	"Performed to stated specifications"
   Specific performance metrics (e.g., SNR, resolution, uniformity, specific safety parameters)	Not provided in the document.

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

   • Sample Size: Not applicable/Not mentioned. The evaluation appears to be based on engineering tests against standards, not clinical patient test sets.
   • Data Provenance: Not applicable/Not mentioned.

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

   • Not applicable. No "ground truth" in the clinical sense (e.g., disease presence/absence in images) was established as this was not a clinical effectiveness trial for a diagnostic algorithm. The evaluation was against engineering and safety standards.

4. Adjudication method for the test set:

   • Not applicable. There was no clinical ground truth requiring adjudication.

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. This device is an MRI coil and mobile system, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.

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

   • Not applicable. This device contains no standalone algorithm.

7. The type of ground truth used:

   • The "ground truth" for this submission refers to the specifications and requirements defined by NEMA performance standards and the IEC 601-1 safety standard. These are technical specifications and safety benchmarks, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm requiring a training set.

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

   • Not applicable. No training set was used.

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