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The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

The MRI Procedure Drape is composed of urethane film, polyethylene EVA copolymer film and polypropylene nonwoven material, creating a sterile barrier for a surgical procedure. The construction includes a suspension system that allows the clear film area to move with the patient as they are moved in and out of the MRI scanner bore.

The provided text describes a 510(k) submission for the "SurgiVision MRI Neuro Surgical Drape and accessories." This submission focuses on establishing substantial equivalence to a predicate device for a medical drape, not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and comparative effectiveness studies are not applicable to this document.

However, I can extract the information that is relevant to the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

1. A table of acceptance criteria and the reported device performance

Explanation: The document states, "Testing to applicable Standards has been completed with positive outcomes." The listed "Top level of testing performed" defines the performance characteristics that were evaluated and met. The "Description of Device" and "Intended Use Statement" also imply the requirement for a sterile barrier and MRI safety, both of which are addressed.

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

The document does not specify sample sizes for the performance tests (tensile, tear, flammability, etc.) or provide details on the data provenance (e.g., country of origin, retrospective/prospective). These are typically contained within the full test reports, which are not included in this summary.

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

Not applicable. This device is a surgical drape, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. Performance testing for drapes typically involves laboratory measurements against established standards.

4. Adjudication method for the test set

Not applicable. As noted above, this involves laboratory performance testing, not subjective interpretation requiring adjudication.

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 device is a surgical drape, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical drape, not an algorithm.

7. The type of ground truth used

For the performance characteristics (sterilization, shelf life, tensile, tear, penetration, flammability), the "ground truth" would be the objective measurements against established performance standards for surgical drapes and materials. For "MRI Safe," the ground truth would be testing confirming compatibility with MRI environments.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning algorithm requiring a training set.

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

Not applicable. This device is a physical product, not a machine learning algorithm.

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