Search Results

The Contour 24 is intended for use with Siemens 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 1.5T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis. The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

I am sorry, but the provided text does not contain the detailed information needed to fill out your request about acceptance criteria and a study proving device performance in the requested format.

The text mentions that "The SNR and uniformity of the Contour 24 was analyzed per NEMA MS-9 and was found to conform to predetermined acceptance criteria" and that "clinical images from volunteer scanning of general human anatomy were obtained from the Contour 24. These images were used to demonstrate that the Contour 24 produces diagnostic quality images of the intended anatomies." However, it does not provide:

• A specific table of acceptance criteria and reported device performance values.
• Sample sizes for test sets, data provenance, or details on ground truth establishment (number of experts, qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Sample size or ground truth establishment for the training set.

Ask a specific question about this device

The Contour 24 is intended for use with Siemens 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis.

The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

Acceptance Criteria and Study for Contour 24

The Contour 24 is a receive-only, 24-channel phased array coil designed for Magnetic Resonance Imaging (MRI) using Siemens 3.0T MR systems. It is intended for imaging general human anatomy, such as the abdomen and pelvis. The device's performance was evaluated through bench testing and clinical imaging to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The summary states that "clinical images from volunteer scanning of general human anatomy were obtained." However, the exact number of volunteers or images used in the clinical performance testing is not specified in the provided document.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involved obtaining "clinical images from volunteer scanning."

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

The document states that the images "can be interpreted by a trained physician." However, it does not specify the number of experts (trained physicians) used to establish the ground truth for the clinical test set, nor does it provide their specific qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set. The term "interpreted by a trained physician" suggests individual interpretation, but no consensus or review process is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The study focused on demonstrating that the Contour 24 produces diagnostic quality images, not on comparing its performance against humans with or without AI assistance, or quantifying an effect size of AI improvement.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The device, Contour 24, is an MRI receive coil, a hardware component that produces images. It is not an algorithm or AI system, so a standalone (algorithm-only) performance study is not applicable to this device. The "performance" being evaluated is the quality of the images it enables, which are then interpreted by a human physician.

7. Type of Ground Truth Used

For the clinical performance testing, the ground truth was based on the ability of "trained physicians" to "interpret" the diagnostic images. This implies expert interpretation/clinical diagnosis based on the generated images. The document does not mention pathology or outcomes data as the ground truth.

8. Sample Size for the Training Set

Since the Contour 24 is a passive hardware device (an MRI coil) and not an AI or algorithm-driven system, there is no "training set" in the context of machine learning. The performance is intrinsically linked to its physical design and engineering.

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

As there is no training set for an AI/ML algorithm associated with this hardware device, this question is not applicable.

Ask a specific question about this device