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The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system.

It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be use in determining diagnosis.

The application area shouldn't be bigger than 20 cm because of the depth of 10 om per coll. The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with sumilar structure can be taken.

The CPC is a multifuntional coil for 1 5T and 3T MRI-systems, with 2x4-channel phased array receive only colls. The coils are pre-tuned in the fixed load and no further tuning or matching is required for the user.

The coll is divided into two spherical parts. Each half contains a 4 channel receive only array. The coils were used together with a parallel imaging procedure.

Each coll has its own plug. The plug is specific to the MRI-system and can't be mixed up with a not designated MRI-system.

The base plate is flat and is suitable on each Siemens MRI-system table.

This document is a 510(k) summary for a medical device called the "CPC Multipurpose Coil." It is a submission to the FDA seeking clearance to market the device, demonstrating its substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/CADe device. This document describes an MRI coil, which is a hardware component, not a software algorithm that would produce performance metrics like sensitivity or specificity.

Here's why the requested information cannot be found in this document:

• Device Type: The "CPC Multipurpose Coil" is an MRI coil, which is a physical component of an MRI system used to acquire images. It is not an AI/CADe device that performs diagnostic interpretation or analysis.
• Regulatory Pathway: This is a 510(k) premarket notification. For hardware devices like MRI coils, the 510(k) process focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does not generally require clinical performance studies with acceptance criteria based on diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a ground truth, as would be expected for an AI algorithm.
• "Acceptance Criteria" for Hardware: For a hardware device like this, "acceptance criteria" generally refer to engineering specifications, safety standards compliance, and performance metrics relevant to image acquisition (e.g., signal-to-noise ratio, uniformity, field of view), not diagnostic accuracy.

Therefore, I cannot provide the requested information. The document focuses on:

• General Information: Importer, manufacturer, contact person.
• Device Name and Classification: Trade name, common name, classification, CFR number, device class, product code.
• Device Description: Multi-channel phased array receive-only coils for 1.5T and 3T MRI systems, pre-tuned, designed for specific MRI systems.
• Intended Use: Body-imaging for diagnostic purposes with an MRI system, to produce images of internal structures for determining diagnosis. Specifies application areas like toes, feet, ankle, knee, etc.
• Substantial Equivalence: Lists several predicate MRI coils the device is compared against.
• Technological Characteristics: Highlights comfortable access to the region of interest.
• General Safety and Effectiveness Concerns: States adherence to IEC 60601-1 and 60601-2-33 standards, and NEMA standards for performance and safety. Mentioned testing on a Siemens Avanto system.
• Conclusion: Affirms substantial equivalence.

The FDA's letter (Page 4-5) confirms the substantial equivalence determination, allowing the device to be marketed under general controls.

In summary, this document does not contain the type of AI/CADe performance study data you are asking for because the device is an MRI coil, not an AI algorithm.

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