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The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate orientation of the coils to the anatomy. These products are to be used with a 1.5T MRI machine.

The Intercept™ Esophageal Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophaqus. The single use, disposable coil is designed for insertion into the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with Siemens 1.5T MRI systems.

The Intercept™ Urethral Internal MR Coil 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 a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with Siemens 1.5T MRI systems. 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™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035" guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices. This product is to be used with Siemens 1.5T MRI systems.

The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.

The provided document is a 510(k) summary for the Intercept™ Esophageal, Urethral, and Vascular Internal MR Coils. It focuses on demonstrating substantial equivalence to previously cleared predicate devices for use with Siemens 1.5T MRI systems. This type of submission generally emphasizes safety and functional equivalence rather than extensive clinical comparative effectiveness studies found in other regulatory pathways.

Therefore, the information typically requested in your prompt regarding acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not extensively detailed. The performance data presented primarily addresses safety and a qualitative assessment of imaging performance.

Here's an attempt to extract and describe the information based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size:
  • RF Heating and Nerve Stimulation: Not explicitly stated as a number of 'cases' but rather as "a phantom study" and "experiments done previously."
  • Imaging Performance: "a volunteer" for the Esophageal coil. So, n=1 for the qualitative imaging performance demonstration for the esophageal coil.
  • Mechanical Testing: Not explicitly stated as a number of units, but "the Esophageal Coil" was tested, implying at least one.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal testing conducted by Surgi-Vision, Inc. These were retrospective analyses of existing data (for nerve stimulation and mechanical testing of the predicate, and newly conducted phantom/volunteer tests for the Siemens compatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The studies described are primarily engineering/phantom tests and qualitative imaging assessments, not clinical studies requiring expert ground truth for diagnostic accuracy.

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

• This information is not applicable/not provided. The studies were not designed for diagnostic adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence in terms of safety and basic imaging capability, not comparative diagnostic performance with or without AI assistance (as AI is not part of this device).

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

• This question is not applicable as the device is an MR coil, not an algorithm or AI system. Its performance is intrinsically tied to its use with an MRI machine and a human operator/interpreter.

7. The type of ground truth used:

• RF Heating: Measured temperature changes in a phantom, compared against physical safety limits.
• Nerve Stimulation: Measurements from previous experiments on current leakage, compared against safety thresholds.
• Imaging Performance: Qualitative assessment of "enhanced resolution" of aortic regions visualized from the esophagus. This is a subjective assessment, likely by internal personnel, rather than a formally established "ground truth" for a diagnostic task.
• Mechanical Testing: Measured bond strengths compared against a defined mechanical requirement (1 lb/f).

8. The sample size for the training set:

• This question is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

• This question is not applicable as the device is not an AI/ML algorithm.

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