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For use to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.

The Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscopes are available in standard and autoclavable 8.0mm, 10.0mm sizes, with 0°, 30° or 45° angles.

The acceptance criteria for the Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscope are focused on MR compatibility within a 1.5 Tesla static magnetic field. The study conducted to prove this compatibility involved testing an 8.0mm endoscope from Greatbatch Scientific in conjunction with a 1.5 Tesla GE Signa Magnet.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: The test set included "A Greatbatch Scientific MR Compatible 8.0mm endoscope". This suggests a sample size of one device (an 8.0mm endoscope) for the tests described.
• Data Provenance: The testing was conducted in a laboratory setting using a 1.5 Tesla GE Signa Magnet. The report does not specify the country of origin but implies a controlled, non-clinical environment. The study is prospective as it involves direct testing of the device for its compatibility.

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

This type of information is not applicable (N/A) to this study. The tests performed are objective physical measurements of the device's interaction with an MR environment (magnetic attraction, torque, artifact, and heating). The "ground truth" is established by direct measurement of physical properties, not by expert interpretation.

4. Adjudication method for the test set:

Not applicable (N/A). As mentioned above, the tests are objective physical measurements. There is no expert adjudication involved in determining magnetic attraction, torque, artifact intensity, or temperature rise. These are measured values against predefined criteria.

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. This study is not an MRMC comparative effectiveness study. It assesses the physical compatibility of a medical instrument with an MR environment, not the performance of an AI algorithm or its impact on human readers.

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

No. This study is not related to an algorithm's performance. It evaluates a physical device (a laparoscope).

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

The "ground truth" for this study is based on objective physical measurements and established MR safety standards/guidelines. The measured values for magnetic attraction, torque, artifact generation, and temperature rise are directly assessed against thresholds considered safe and acceptable for an MR-compatible device.

8. The sample size for the training set:

Not applicable (N/A). This study describes the testing of a physical medical device for MR compatibility. There is no "training set" as there is no machine learning or AI component involved.

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

Not applicable (N/A). As there is no training set.

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