Search Results

The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems. The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.

The MRgFUS Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in both rigid and semi-flexible housing that is fire rated and has a high impact and tensile strength.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MRgFUS Pelvic Coil:

Summary of Acceptance Criteria and Device Performance:

The document describes the MRgFUS Pelvic Coil as a device substantially equivalent to a predicate device (Pelvic Array Coil by USA Instruments, Inc.). The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device and meeting relevant established performance standards for medical electrical equipment and MRI coils. The reported device performance is that it conforms to these standards and specifications.

Study Information Based on Provided Text:

The provided document is a 510(k) summary for a premarket notification, which largely focuses on demonstrating substantial equivalence. It does not describe a detailed clinical or comparative effectiveness study in the way a traditional research paper would. Instead, it relies on testing against established standards and direct comparison of technical characteristics to a predicate device.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not specify a sample size or test set in terms of patient data. The "testing" mentioned refers to engineering and performance testing of the device itself against technical specifications and recognized standards, not a clinical study on human subjects or image data sets.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This information is not applicable as no clinical "test set" requiring ground truth establishment by experts is described in the document.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not applicable as no clinical "test set" requiring adjudication is described.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done or reported for this device based on the provided text. This device is a hardware component (an RF coil) for an MRI system, not an AI or software assistant for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a hardware component, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the context of a clinical performance study. The "ground truth" for this submission revolves around established engineering standards (IEC, UL, NEMA) and the technical specifications of the predicate device.

7. The sample size for the training set:

   • Not applicable. No training set for an algorithm or AI model is mentioned or implied.

8. How the ground truth for the training set was established:

   • Not applicable. As no training set is described, there's no ground truth establishment for it.

Conclusion:

The provided 510(k) summary for the MRgFUS Pelvic Coil details a submission focused on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing technical characteristics and showing compliance with established safety and performance standards. It does not include a clinical trial, AI performance study, or any form of human-reader evaluation study. The "study" largely refers to engineering tests and comparisons against a predicate, rather than the types of clinical performance studies often associated with AI medical devices.

Ask a specific question about this device