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The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist.

Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist. The images produced by the MAGNETOM ESSENZA with the, 14-Channel Extremity Coil reflects the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.

The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.

Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist.

The provided text describes the 510(k) summary for the Siemens 14-Channel Extremity Coil for 1.5T MAGNETOM ESSENZA. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics that would typically involve a test set, expert adjudication, or MRMC studies.

Here's an breakdown of what can be extracted and what is missing:

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

The document lists safety and performance parameters considered, but it does not specify quantitative acceptance criteria or specific reported device performance values against these criteria. Instead, it states that these parameters were considered and that testing showed equivalence with a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "laboratory testing" but does not detail the nature of the test set (e.g., patient data, phantom studies), sample size, or provenance. This is a device modification for an existing technology (MR coil), and typically for such submissions, the focus is on technical equivalence rather than clinical performance studies with patient data.

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)

This information is not provided. Given the nature of a magnetic resonance coil submission, it's unlikely that expert-adjudicated ground truth for a test set of clinical images would be a primary requirement unless novel image interpretation features were introduced. The document emphasizes technical equivalence.

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

This information is not 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

An MRMC comparative effectiveness study was not conducted or mentioned. This is not an AI-assisted device; it's a hardware component (an MRI coil). Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This is not an AI algorithm. It is a hardware component. Therefore, a standalone algorithm performance study is not applicable.

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

The document primarily relies on technical performance metrics (e.g., SNR, uniformity, SAR) and comparison to a predicate device. If patient images were used in testing, the ground truth source is not specified, and typically for coil submissions, the "ground truth" would be the objective measurements of image quality and safety parameters.

8. The sample size for the training set

This is not an AI/software device that requires a training set. This information is not applicable and not provided.

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

This is not an AI/software device that requires a training set. This information is not applicable and not provided.

Summary of the Study (as described in the document):

The study primarily focused on demonstrating substantial equivalence to a predicate device (QED TxRx 15Ch Knee Coil 1.5T). The method involved:

• Comparison of Intended Use and Device Description: Showing the new coil is used for the same anatomical regions and produces the same types of images as the predicate.
• Assessment of Safety Parameters: Verifying that parameters like Maximum Static Field, Rate of Change of Magnetic Field, and Acoustic Noise Level are unaffected, and that RF Power Deposition (SAR) and Biocompatibility are equivalent to the predicate device.
• Assessment of Performance Parameters: Verifying that Geometric Distortion, Slice Profile, Thickness and Gap, and High Contrast Spatial Resolution are unaffected, and that Signal to Noise Ratio (SNR) and Image Uniformity are equivalent to the predicate device.
• Laboratory Testing: "Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness." This testing specifically covered SNR, image uniformity, and SAR.

The document states that the results presented in the submission show that they (SNR, image uniformity, SAR) are equivalent with the predicate devices. This "equivalence" is the primary acceptance criterion and the outcome of the study.

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