(85 days)
The Intercept-Urethral Microcoil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with a 1.5T GE Signa MRI machine. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.
The Intercept-Urethral Microcoil (IUMC) is an intracavitary specialty coil for use in MRI imaging of the anatomical regions surrounding the urethra. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The imaging coil and the coaxial cable are completely sealed inside the insulating sleeve. This device is advanced into the subject's urethra and positioned in the region of interest. The balancing and decoupling circuit is located outside the body.
The provided text is a 510(k) summary for the Intercept-Urethral Microcoil (IUMC). It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria, numeric performance metrics (sensitivity, specificity, AUC), or a detailed study description with a test set, ground truth experts, or training set information as requested in the prompt.
The document states that the imaging performance was evaluated and that "The imaging performance was evaluated in the male and female urethra. These images are shown in Exhibit 7." However, Exhibit 7 is not provided in the given text, and therefore, no quantitative performance metrics for imaging performance are available to construct the acceptance criteria table.
Based on the provided text, I can extract the following information about the studies performed, but without the specific numerical acceptance criteria or performance results:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes the types of tests performed and their general outcomes ("no excess heating," "no possibility of increased susceptibility," "imaging performance was evaluated," "met performance specifications"), but it does not provide specific, quantifiable acceptance criteria or numerical performance results (e.g., a specific temperature threshold, a specific imaging quality score, or mechanical specifications). Therefore, this table is based on the qualitative outcomes described.
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Excess RF Heating | No excess heating when IUMC is positioned in a phantom representative of worst-case clinical conditions. Change in temperature not significantly different than without the coil. |
| Peripheral Nerve Stimulation | No possibility of increased susceptibility of patients to peripheral nerve stimulation (based on current leakage calculations). |
| Imaging Performance | Evaluated in the male and female urethra (images shown in Exhibit 7, not provided). |
| Mechanical Testing | No safety issues found; all performance specifications (stiffness, tensile, tracking, torque, electrical testing) were met to satisfaction. Mechanical flexing resulted in insignificant changes in electrical properties. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for imaging performance. For RF heating, a "phantom that is representative of worst case clinical conditions" was used. For mechanical testing, individual components underwent testing.
- Data Provenance: Not explicitly stated. The studies appear to be laboratory-based and phantom-based for heating and mechanical testing. Imaging performance evaluation was done on "male and female urethra," implying human subjects, but details are not provided. Origin (e.g., country) is not mentioned.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not specified. The document does not describe a ground truth establishment process involving experts for the tests mentioned. For imaging performance, it only states that images were evaluated and shown in an exhibit.
4. Adjudication Method for the Test Set
- Not specified. No mention of an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes tests related to safety (heating, nerve stimulation, mechanical) and general imaging performance, not a comparison of human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- This is not applicable as the device described (Intercept-Urethral Microcoil) is an accessory to an MRI system designed to improve image quality, not an AI algorithm. Its "standalone" performance refers to its physical and electrical properties, not an algorithmic output.
7. Type of Ground Truth Used for the Test Set
- For RF Heating and Nerve Stimulation: Calculated values and phantom measurements, comparing with and without the coil.
- For Mechanical Testing: Performance specifications (presumably engineering standards and internal benchmarks).
- For Imaging Performance: "Evaluated in the male and female urethra" - the specific ground truth (e.g., clinical diagnosis, pathology) is not described, nor is how the "evaluation" was performed (e.g., by experts, objectively).
8. Sample Size for the Training Set
- Not applicable. The device is a physical medical device (a coil), not a software algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is a physical device and not an AI algorithm.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.