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The Mark III Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark III Phased Array Coil is designed for use with the Signa EXCITE 3T MRI scanner manufactured by GE Medical Systems, Inc.

The Mark III Phased Array Coil consists of three volume RF coil elements in a phased array design. The coil elements and associated circuitry are enclosed to prevent any exposure to the patient or environment. The coil electronics are enclosed in both the rigid housing and the vinyl coated PVC foam. The coil is positioned on the patient's shoulder during imaging.

The provided text describes a Special 510(k) Premarket Notification for the Mark III Phased Array Shoulder Coil. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical or performance study data with defined acceptance criteria in the same way a new, high-risk device might. The document submitted for K042009 is a Traditional 510(k), which is typically for new devices. However, the internal title indicates 'Special 510(k)', which refers to an easier route for devices that are modifications to one's own legally marketed devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document. The 510(k) submission primarily relies on comparisons to legally marketed predicate devices to establish safety and effectiveness.

Here's an analysis of what is available and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative performance metrics (e.g., signal-to-noise ratio, image resolution, specific absorption rate (SAR) limits) that the device must meet, and corresponding test results to prove these metrics are met. The document states "power deposition during imaging is limited by SAR algorithm", but doesn't specify the accepted SAR limits or the measured SAR of the device.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information: The document does not describe a "test set" in the context of clinical or performance data generation. The submission relies on a comparison to predicate devices, not independent testing on a new dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Missing Information: Not applicable. No test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

Missing Information: Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Missing Information: No MRMC study is described. The submission focuses on technical equivalence rather than clinical comparative effectiveness.

6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

Missing Information: Not applicable. This device is a passive RF coil, not an algorithmic device requiring standalone performance testing in that sense. The 'performance' is implied by its design similarity to predicate devices.

7. The Type of Ground Truth Used

Missing Information: Not applicable. No new ground truth needed to be established for this submission, as it relies on the established safety and effectiveness of predicate devices.

8. The Sample Size for the Training Set

Missing Information: Not applicable. This device is a hardware component, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Missing Information: Not applicable. No training set is described.

Summary of the Study/Evidence Provided:

The "study" presented in this 510(k) notification is primarily a direct comparison of the Mark III Phased Array Shoulder Coil to legally marketed predicate devices. The manufacturer, USA Instruments, Inc., established substantial equivalence by demonstrating that their new coil has:

• Similar Intended Use: Shoulder imaging applications.
• Similar Indications for Use: Identical to routine MRI imaging.
• Similar Design Principles: Receive-only phased array design, decoupling methods (switching diode decoupling), and methods for preventing RF burns (does not transmit RF power, coil elements isolated and enclosed in non-conductive housing).
• Similar Materials: Coil enclosure materials (Vinyl coated PVC foam, Flame retardant Polyurethane Plastic, PVC Plastic).

Predicate Devices Used for Comparison:

• Mark 9000 Shoulder Coil manufactured by USA Instruments Inc. (K010946)
• Phased Array Shoulder Coil manufactured by Medical Advances Inc. (K945778)
• Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K994345) (for enclosure materials)
• Excalibur 9000 TotalSENSE™ Quad Array-Head Coil manufactured by USA Instruments, Inc. (K022582) (for prevention of RF burns)

The safety and effectiveness argument is built upon the premise that because the Mark III Phased Array Shoulder Coil shares fundamental design characteristics, intended use, and indications for use with other legally marketed devices, it can be considered equally safe and effective. The FDA's letter concurs with this determination of substantial equivalence.

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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholanqiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan,Cine Imaging and Cardiac tagging.]
• Fluid Visualization .
• 2D / 3D Imaging ●
• MR Angiography / MR Vascular Imaging .
• . Blood Oxygenation Level Dependent (BOLD) imaging
• Perfusion / Diffusion Imaging .
• Proton Spectroscopy .

The EXCELART Vantage™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.

• New gantry design as Ultra-short bore. .
• . New patient couch design as wide couch top.
• It is possible to combine detachable couch top and gurney of exclusive use. .
• . The CPU of computer system was changed from RISC type to Xeon.
• . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
• . SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
• The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
• The gating waveform can be displayed by the side of the gantry. .

This document describes a 510(k) submission for the EXCELART Vantage™ XGV/AGV MRI system. The submission focuses on demonstrating substantial equivalence to a predicate device, the EXCELART™ with Pianissimo XG/AG SPIN Edition.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparing the safety and imaging performance parameters of the new device to its predicate. The acceptance criteria essentially align with maintaining or improving upon the predicate device's specifications, particularly within regulated safety limits.

Notes on the table:

• Acoustic Noise: The new device reports a higher acoustic noise (110 dB) compared to the predicate (95.4 dB). While this is a change, it's presented within the context of substantial equivalence, implying it still meets regulatory limits or is otherwise deemed acceptable. MRI systems can have varying acoustic noise levels depending on gradient strength, pulse sequences, and patient comfort features.
• Maximum SAR: The new device allows for a higher maximum SAR (< 2.0 W/kg) compared to the predicate (< 1.5 W/kg). This is explicitly stated as being in compliance with IEC 60601-2-33 (2002).
• Maximum dB/dt: The new device specifies "<1st operating mode specified in IEC 60601-2-33 (2002)," indicating compliance with international safety standards, which may differ from the numerical value of the predicate.
• Gradient coil dimensions: The dimensions have changed, which is expected with a "short bore" magnet system. This is a design change rather than a performance criterion for acceptance.
• Imaging Performance: The document explicitly states "No changes from the previous submission, K023511," for imaging performance, implying that the new device's imaging capabilities are at least equivalent to the predicate.

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

The document does not provide details on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's clinical performance. This is because the submission is for an MRI system, not a diagnostic algorithm or a device that directly measures a clinical outcome through data analysis. The "study" here refers to the engineering and regulatory review demonstrating that the new MRI system meets safety and performance specifications relative to its predicate.

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

Not applicable. As noted above, this submission is for an MRI system, and does not involve clinical data analysis requiring expert-established ground truth for a test set. The "ground truth" for the device's technical performance is established through engineering specifications, international safety standards (like IEC 60601-2-33), and comparison to the predicate device's cleared specifications.

4. Adjudication method for the test set

Not applicable, as there is no mention of a test set requiring adjudication in this 510(k) summary.

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 document pertains to an MRI scanner system, not an AI-powered diagnostic tool. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this submission.

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

Not applicable. This is not for a standalone algorithm.

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

The ground truth for the performance evaluation in this 510(k) submission is primarily based on:

• Engineering Specifications: Adherence to defined technical parameters (e.g., field strength, gradient coil characteristics).
• International Safety Standards: Compliance with standards like IEC 60601-2-33 (2002) for SAR and dB/dt limitations.
• Predicate Device Equivalence: The performance and safety characteristics of the new device are measured against the legally marketed and cleared predicate device (K023511).

8. The sample size for the training set

Not applicable. This submission concerns hardware and software modifications to an MRI system, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.

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