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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, anterior neck, cervical spine, and vessels of the head and neck to the aortic arch, that can be interpreted by a trained physician.

Model HNC Neurovascular Array Coil

Regrettably, the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for the Model HNC Neurovascular Array Coil.

Here's a breakdown of what is and is not in the provided text:

Information Present:

• Device Name: Model HNC Neurovascular Array Coil
• Regulatory Class: Class II (21 CFR 892.1000/Procode: 90 MOS)
• Indications For Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, anterior neck, cervical spine, and vessels of the head and neck to the aortic arch, that can be interpreted by a trained physician."
• FDA Determination: The device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This means the FDA believes the device is as safe and effective as a legally marketed predicate device, but it does not typically mean a full clinical efficacy study with specific acceptance criteria was conducted or reviewed by the FDA as part of the 510(k) clearance process.

Information NOT Present (and why it's not typically in a 510(k) clearance letter):

• A table of acceptance criteria and reported device performance: 510(k) clearances usually rely on demonstrating substantial equivalence to a predicate device, often through bench testing and sometimes limited clinical data, but not typically a full-scale clinical trial with predefined acceptance criteria for performance metrics like sensitivity, specificity, or AUC, as would be expected for a novel AI device.
• Sample size and data provenance for a test set: This level of detail on a specific study is absent.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: This device is a hardware component (a coil for an MRI scanner), not an AI algorithm, so this concept is not applicable.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not applicable for a hardware device.
• How the ground truth for the training set was established: Not applicable for a hardware device.

Conclusion:

The provided FDA letter for the Model HNC Neurovascular Array Coil is a 510(k) clearance letter. For devices cleared via the 510(k) pathway, the primary mechanism for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than a de novo clinical trial with specific performance-based acceptance criteria against a defined ground truth, as would be common for AI/ML devices. Therefore, the document does not contain the information you requested about detailed acceptance criteria and a study proving a device meets them in the way described for an AI/ML product.

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