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MRI array coil for human extremities imaging Anatomical region: Anatomies in human extremities that have cross sectional diameter no larger than 4 "

High Temperature Superconducting (HTS) array coil

The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information regarding detailed acceptance criteria, a study proving the device meets these criteria, or specific performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text. The letter primarily states that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to proceed to market. It does not delve into the technical study details typically associated with acceptance criteria and performance validation.

Here's why the specific points cannot be addressed based on this document:

1. Table of acceptance criteria and reported device performance: This document does not list any acceptance criteria or device performance data.
2. Sample size, data provenance: No information on any studies, test sets, or data origin is present.
3. Number of experts, qualifications: The document is a regulatory clearance and does not discuss human expert involvement in evaluating the device's performance.
4. Adjudication method: Not applicable as no study details are provided.
5. MRMC comparative effectiveness study: No such study is mentioned.
6. Standalone performance study: No details of any performance study (standalone or otherwise) are given.
7. Type of ground truth: Not applicable as no study details are provided.
8. Sample size for training set: Not applicable as no details of any training set or algorithm are provided.
9. How ground truth for training set was established: Not applicable.

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MRI surface coil for peripheral anatomical imaging Anatomical region: Temporo-mandibular joint (TMJ), wrist and other anatomies that are no deeper than 1.5 inches fro the skin.

High Temperature Superconducting (HTS) coil

This 510(k) letter is for a device called "HTS Coil" (High Temperature Superconducting coil). However, the letter only states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information would typically be found in the 510(k) submission itself, which is not provided in this document.

Therefore, I cannot provide the requested information. The provided document is a regulatory approval letter, not a technical report detailing the device's performance studies.

Ask a specific question about this device