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The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower cranium.

The Carotid Coil GE1.5T is a receive-only 2-channel coil for operation at a magnetic field strength of 1.5T with the GE Twinspeed HDx system. The coil is a two-element coil consisting of two independent rectangular loops, each of approximate size 7 cm x 4.5 cm. Coupling of either coil element to the transmitted field is prevented through respective active blocking circuits. The Carotid Coil GE1.5T is specially designed for MR imaging of the carotid arteries in the region of the neck and lower cranium. The coil provides optimum signal to noise ratio and coverage in the area of the carotid arteries, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 7 cm Field of View.

The provided document is a 510(k) premarket notification for a medical device called "Carotid Coil GE1.5T". This document describes the device, its intended use, and its substantial equivalence to predicate devices, in accordance with FDA regulations.

However, it does not contain information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical effectiveness. The "Performance Testing & Standards" section and "Safety and Effectiveness" section focus on compliance with electrical, mechanical, flammability, and biocompatibility standards, and a side-by-side comparison for substantial equivalence, rather than a clinical study with outcome-based acceptance criteria regarding diagnostic accuracy.

Therefore, the requested information elements related to diagnostic performance, ground truth, sample sizes for test/training sets, expert involvement, and MRMC studies are not available in this document.

Here's a breakdown of what is available and what is not:

Description of the Acceptance Criteria and Device Performance (Limited to Safety and Equivalence)

The acceptance criteria for the Carotid Coil GE1.5T, as described in this 510(k) summary, are primarily centered around safety and substantial equivalence to legally marketed predicate devices, rather than specific diagnostic accuracy metrics. The device's "performance" in this context refers to its ability to function safely and similarly to existing technology.

Acceptance Criteria for Safety and Effectiveness (as inferred from the document):

1. Compliance with Safety Standards: The device must meet international and national safety standards for medical electrical equipment, flammability, and biocompatibility.
2. Substantial Equivalence in Performance: The device must demonstrate performance that is substantially equivalent to predicate devices in terms of image quality capabilities (e.g., Signal-to-Noise Ratio (SNR), coverage, allowing high-resolution imaging suitable for the intended use).
3. No New Potential Safety Risks: The device should not introduce any new or unacceptable safety risks compared to the predicate devices.

Reported Device Performance (against the inferred criteria):

• Safety Compliance: Tursiop Technologies, LLC states compliance with:
  • IEC 60601-1 (1988) with amendments (Medical electrical equipment safety)
  • IEC 60601-2-33 (2006) (Safety of magnetic resonance equipment)
  • UL 94 (Tests for Flammability of Plastic Materials)
  • ISO 10993-1 (2009) (Biological evaluation of medical devices)
  • NEMA MS-6 (2008) (Characterization of Special Purpose Coils)
  • NEMA MS-9 (2008) (Characterization of Phased Array Coils)
  • ISO 13485-certified for design and manufacture.
  • Risk assessment (FMEA) procedures utilized to mitigate risks.
  • Patient contacting surface material (polycarbonate with biocompatible paint) is safe.
  • "The Carotid Coil GE1.5T does not introduce any new potential safety risks."
• Substantial Equivalence (Performance Aspect):
  • "Side by side comparison testing was conducted with one of the predicate devices, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance."
  • The Carotid Coil GE1.5T offers "Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, while the sensitive region of the coils covers an approximately 7 cm Field of View." (This is compared to predicate devices also claiming optimal SNR, coverage, and high-resolution imaging, though with slightly different FOV specifications for one predicate).

Table of Acceptance Criteria and Reported Device Performance

Information Not Available / Not Applicable for this Device Type and Submission:

This 510(k) submission primarily addresses the substantial equivalence of a medical device accessory (an MRI coil) based on technical, safety, and performance characteristics compared to existing devices. It is not a clinical study to evaluate diagnostic accuracy outcomes of an AI-powered diagnostic algorithm. Therefore, the following requested information is not present or relevant to this document:

1. Sample size used for the test set and the data provenance: Not applicable. The "testing" referred to is engineering and side-by-side comparison for equivalence, not a clinical diagnostic performance study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic accuracy was established in this context.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance: Not applicable. This is an MRI coil, not an AI diagnostic software.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable. No AI model training is described.
8. How the ground truth for the training set was established: Not applicable.

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