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The Picker Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.

The Large Phased Array Neck Coil is a receive-only coil for the 0.23T Outlook system, and is optimized to image the cervical spine. The sensitive region of the coil covers the base of the cerebellum to the third thoracic vertebra for greater than 98% of patients.

The provided text is a 510(k) premarket notification for a medical device, specifically an MRI coil. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performing an in-depth study to prove the device meets these criteria in the way a novel diagnostic AI algorithm might.

Therefore, many of the requested elements for an AI or diagnostic device study are not applicable in this context. The "acceptance criteria" here are essentially the demonstration of equivalent performance and safety characteristics to the predicate devices.

Here's an attempt to address your request based on the provided document, highlighting where the information is not present or not directly applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Enclosure Material
• Coil Design
• Decoupling
• Prevention of Resonant Loops
• Prevention of RF burns
• Radio Frequency Absorption | Same as predicate devices |
  | Effectiveness (Indications)| Equivalent indications for use as predicate devices. | "The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region." (Same as predicate) |
  | Intended Use | Equivalent intended use as predicate devices (for NMR imaging for diagnosis by a trained physician). | Same as predicate devices |
  | Compatibility | Compatible with Picker 0.23T Outlook system. | Compatible with Picker 0.23T Outlook system |
  | Tuning Scheme | Automatically tuned for each patient, equivalent to predicate. | Automatically tuned for each patient |
  | Anatomic Regions | Neck, from cerebellum to upper thoracic spine, equivalent to predicate. | Neck |
  | Nuclei Excited | Hydrogen, equivalent to predicate. | Hydrogen |

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

• Not applicable. This submission relies on demonstrating substantial equivalence to existing devices, primarily through comparison of design, materials, and functional specifications, rather than a clinical trial with a "test set" of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. No ground truth in the context of diagnostic interpretation is established for this submission. The "ground truth" for regulatory approval is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No test set or human interpretation adjudication was part of this submission.

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

• No. This is not a study comparing human reader performance with and without AI assistance. It's a device comparison for substantial equivalence.

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

• Not applicable. This is a physical medical device (an MRI coil), not a standalone algorithm.

7. The Type of Ground Truth Used

• Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is the regulatory acceptance and established safety/effectiveness of the predicate devices (USAI Quadrature Volume Neck Coil and Picker Phased Array Neck Coil). The manufacturer is asserting that the new device is functionally identical or very similar in all critical aspects affecting safety and efficacy.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm or a clinical trial for this type of device.

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

• Not applicable. See point 8.

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