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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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The Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest extending to the cardiac region in Magnetic Resonance Imaging Systems. The Millennium 5000 Neurovascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.

The indications for use are the same as for standard imaging:

The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium 5000 Phased Array Neurovascular Coil is a 4-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, an open designed head former, and a detachable chest plate. The split-top, three piece design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

This document is a 510(k) premarket notification for a medical device called the "Millennium 5000 Phased Array Neurovascular Coil." It describes the device and claims substantial equivalence to previously cleared devices, rather than presenting a study to prove performance against specific acceptance criteria.

Therefore, the requested information elements related to a study (like sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, clinical outcomes, etc.) are not available in this document.

The document primarily focuses on demonstrating that the new device has similar characteristics and intended use to existing devices, which is the basis for a 510(k) clearance, not a clinical performance study with predefined acceptance criteria.

However, I can extract information regarding the device's intended use, description, and comparison to predicate devices, which serves as the "performance" relevant to a 510(k) submission.

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similarity to predicate devices, and the "reported device performance" is a description of its features and intended use, aligning with those of the predicates.

Regarding the other requested points, they are not applicable or estimable from the provided document as it is a 510(k) submission based on substantial equivalence, not a clinical performance validation study:

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

• Not applicable/Not provided. This document does not describe a test set or clinical study data. It relies on comparison to existing legally marketed devices.

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)

• Not applicable/Not provided. No ground truth establishment is described for a test set.

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

• Not applicable/Not provided. No adjudication method is described.

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/Not provided. This is a hardware device (MRI coil), not an AI-assisted diagnostic product. No MRMC study was performed or described.

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

• Not applicable/Not provided. This is a hardware device, not an algorithm.

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

• Not applicable/Not provided. No ground truth is described.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI or software device that undergoes training.

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

• Not applicable/Not provided. No training set or ground truth for it is relevant to this submission.

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The Premier III Phased Array CTL Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.

The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner.

The indications for use are the same as for standard imaging:

The GE Medical Systems 3.0Tesla system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Premier III Phased Array CTL Spine Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premier III Phased Array CTL Spine Coil:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit performance metrics against predefined acceptance criteria. The "reported device performance" is primarily a statement of similarity to predicate devices already cleared by the FDA.

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

The document does not describe a test set or test data in the way one would for a clinical performance study of a diagnostic algorithm or new technology. The safety and effectiveness information is presented as a comparison to predicate devices. There is no mention of a specific sample size of images or patients used for performance testing.

Therefore:

• Sample size for test set: Not applicable/not provided in this document.
• Data provenance: Not applicable/not provided in this document. The comparison is feature-based against existing cleared devices, not data-driven.

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

There is no mention of experts being used to establish ground truth for a test set. This type of evaluation is characteristic of studies assessing the diagnostic accuracy of AI or interpretive devices, which is not the nature of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no test set or ground truth establishment process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission is for an accessory (an RF coil) to an MRI system, not a diagnostic algorithm.

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

No, a standalone performance study was not conducted or described. This device is a passive RF coil; it does not perform any algorithmic analysis or interpretation.

7. The Type of Ground Truth Used

Not applicable, as no ground truth was established for performance testing of this device. The regulatory pathway here is substantial equivalence based on physical and functional characteristics compared to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware accessory; it does not involve machine learning algorithms that require training sets.

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

Not applicable, as there is no training set for this device.

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