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The Cervix Coil Latex Sheath allows use of the coil in MR scanning procedures for endocavitary exams of the cervix while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the coil. The latex coil cover is furnished as a non-sterile, single use (patient/procedure), disposable device.

The Cervix Coil Latex Sheath has been specifically designed to fit over the Picker Hammersmith Endocavitary Cervix Coil. The sheath has an extension on the closed end that can be depressed into the center of the coil. This allows placement of the cervix within the MR coil ring without interference from the sheath. This disposable sheath prevents transfer of microorganisms, body fluids, and particulate material during reuse of the coil.

Here's a breakdown of the acceptance criteria and study information for the Cervix Coil Latex Sheath, based on the provided document:

The device, a "Cervix Coil Latex Sheath," is a Class II device intended to allow the use of an MRI coil in endocavitary exams of the cervix while preventing the transfer of microorganisms, body fluids, and particulate material. It's a non-sterile, single-use, disposable device. The submission focuses on demonstrating substantial equivalence to a predicate device, the CIVCO Latex Ultrasound Transducer Covers (K970515), rather than providing detailed acceptance criteria and a study to meet those criteria in a typical performance study format. The "study" here is essentially the comparison and justification of equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the predicate device, and the "reported device performance" is the claim that the Cervix Coil Latex Sheath shares these characteristics.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the traditional sense of a performance study with a test set of data. The "test" here is the comparative analysis against the predicate device's established characteristics.
• Data Provenance: The document focuses on demonstrating conceptual and material equivalence rather than providing performance data from a specific "test set." The predicate device's data would be considered prior knowledge.

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

• Not applicable. There isn't a "test set" requiring expert ground truth establishment for this type of submission.

4. Adjudication Method:

• Not applicable. No expert adjudication process described.

5. 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:

• Not applicable. This is not an AI/imaging diagnostic device.

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

• Not applicable. This is a medical device accessory, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the assessment of the Cervix Coil Latex Sheath is the established safety and effectiveness profile of the predicate device, the CIVCO Latex Ultrasound Transducer Cover, as demonstrated through its own testing and market experience. The manufacturer argues that because the new device is "substantially equivalent" in design, material, manufacturing, and intended performance, it inherits the predicate's ground truth for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set is involved.

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