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The QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints.

The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (Shoulder Coil) to increase the clinical utility of the AIRIS II in the stationary configuration. The Shoulder Coil can operate either in the quadrature mode or in the phased array mode with the AIRIS II.

AIRIS II software did not need to be revised in order to support full functionality of these coils.

This appears to be a 510(k) summary for a new RF coil (Shoulder Coil) for an existing MRI system (Hitachi AIRIS II), not a study evaluating the performance of a new medical device in the typical sense of AI/image analysis. The document details the technical characteristics and intended use of the coil, emphasizing its substantial equivalence to a predicate device.

Therefore, many of the requested items (acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this specific regulatory submission.

Here's why and what information can be extracted:

Reasoning for Non-Applicability:

• Device Type: The device is an accessory RF coil for an MRI system, not a software algorithm, diagnostic AI tool, or a novel imaging modality requiring extensive clinical endpoint studies.
• Regulatory Pathway: A 510(k) submission for an accessory like this primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. This typically involves technical comparisons (e.g., design, materials, performance specifications) rather than new clinical trials with detailed performance metrics against ground truth.
• Nature of the Document: This is a summary of safety and effectiveness, outlining the device's characteristics and intended use, not a detailed scientific report of a performance study.

Information that can be extracted or inferred:

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

• Acceptance Criteria: For an RF coil, the acceptance criteria are generally focused on technical performance and safety, demonstrating that it functions as intended and does not introduce new risks compared to the predicate device. These are implicitly assumed to be met for 510(k) clearance based on the substantial equivalence argument.
  • Implicit Acceptance Criteria (based on 510(k) of an MR accessory):
    • RF Coil Uniformity (mentioned as an imaging capability)
    • Compatibility with AIRIS II MRI system software and hardware.
    • Ability to produce diagnostic quality images of the shoulder and other large joints.
    • Safety standards for MR coils (e.g., SAR limits, heating, noise).
    • Performance comparable to legally marketed predicate devices.
• Reported Device Performance: The document does not report specific performance metrics from a study in the way an AI algorithm might report sensitivity/specificity. Instead, it states that:
  • "The QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints."
  • It operates "either in the quadrature mode or in the phased array mode."
  • "AIRIS II software did not need to be revised in order to support full functionality of these coils."
  • It is "Identical to the Predicate Device" in technological characteristics.

Table (Best Effort based on available info):

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

• Not Applicable. This document does not describe a clinical performance study with a test set of patient data to evaluate a diagnostic algorithm. The clearance is based on technical specifications and substantial equivalence.

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

• Not Applicable. See point 2. Ground truth establishment for diagnostic performance is not relevant for this type of regulatory submission.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 is an RF coil, not an AI or diagnostic algorithm. No MRMC study was performed or is relevant for this type of device.

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

• Not Applicable. This is an RF coil, not a standalone algorithm.

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

• Not Applicable. Ground truth for diagnostic performance is not relevant for this type of device and submission. The "ground truth" for an RF coil is its physical and technical performance specifications and its ability to consistently produce images as expected.

8. The sample size for the training set

• Not Applicable. This is an RF coil, not a machine learning model. No training set is involved.

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

• Not Applicable. See point 8.

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