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Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination. This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.

The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which has been coated with .5 mil of linear low density polyethylene extrusion. The material is blue in color, cut to an overall length and width of 114" x 54", and is 5 mils thick. Through the use of pressure sensitive adhesive tape, the cover can be attached to a clean, dry surface to establish a barrier.

This request pertains to the acceptance criteria and study details for a Sterile Disposable Equipment Magnet Cover. However, the provided document is a 510(k) premarket notification summary for this device, and it primarily focuses on detailing the device description, performance standards through internal testing, and its intended use, rather than a clinical study comparing its performance against acceptance criteria in a typical clinical setting or a multi-reader multi-case study.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes for test/training sets, experts, adjudication, MRMC studies, or standalone algorithm performance, is not present within the provided text.

The document describes material performance tests, which can be seen as meeting specific internal "acceptance criteria" for the material properties.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where gaps exist:

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

The document describes performance standards for the material used in the device. These can be considered the acceptance criteria for the material's properties.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for material testing. For example, for flammability, a "material was tested" suggests a sample was used, but the number of samples is not given.
• Data Provenance: Not applicable in the sense of patient data. These are laboratory-based material property tests, presumably conducted by or for Contour Fabricators, Inc. The document does not specify a country of origin for the testing data beyond the company's US location.
• Retrospective or Prospective: Not applicable. These are tests on manufactured material.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" here is the measured physical property of the material, not an expert-derived clinical diagnosis or assessment. The tests are based on established standards (e.g., 16 CFR 1610) and engineering methods.

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

Not applicable. These are objective material property measurements, not subjective evaluations requiring adjudication among multiple readers.

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

No such study was mentioned or required for this type of device (Sterile Disposable Equipment Magnet Cover). This device is a physical barrier, not an AI-powered diagnostic tool.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance standards described is based on objective physical measurements and adherence to regulatory standards (e.g., flammability standard 16 CFR 1610) or established engineering test methods (fluid penetration test).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. See point 8.

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