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The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.

Here's a breakdown of the acceptance criteria and study information for the Greatbatch Scientific MR Compatible Sinuscope, based on the provided documents:

Acceptance Criteria and Device Performance

Study Information

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

   • Magnetic Attraction & Torque: The testing involved a single device (the Greatbatch Scientific MR Compatible Sinuscope). The data provenance is laboratory testing conducted by Greatbatch Scientific, likely in the USA.
   • Artifact: The testing involved a single device. Data provenance is laboratory testing by Greatbatch Scientific.
   • RF Heating (Phantom): A single phantom was used. Data provenance is laboratory testing by Greatbatch Scientific.
   • RF Heating (Clinical): The document states "Clinical" but does not specify the number of subjects or the methodology, only the SAR applied and duration. This suggests an in-vivo test, but the exact sample size is not provided. Data provenance is implied to be clinical testing arranged by Greatbatch Scientific.
   • Gradient Induced Voltage (Clinical): The document states "Clinical" results without specifying the number of subjects or methodology. Data provenance is implied to be clinical testing arranged by Greatbatch Scientific.

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

   • This device is a physical instrument, not an AI or diagnostic system. Therefore, "ground truth" as typically understood in AI/diagnostic studies (e.g., expert consensus on images or pathology) is not applicable here. The "truth" is established by direct physical measurement against predefined engineering and safety standards for MR compatibility. The experts would be the engineers and scientists conducting the MR safety tests. Their specific qualifications are not detailed but are assumed to be competent in MR safety testing.

3. Adjudication method for the test set:

   • Not applicable. This is a physical device performance test (MR compatibility), not a diagnostic assessment requiring adjudication of interpretations. The measurements are objective.

4. 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 is not an AI or diagnostic device. This type of study is not relevant.

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

   • No, this is a physical medical device, not an algorithm. Standalone performance as an algorithm is not applicable.

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

   • The "ground truth" for MR compatibility is based on objective physical measurements against established safety standards for magnetic attraction, torque, artifact generation, RF heating, and gradient-induced voltage. These standards dictate acceptable limits for safe use in an MR environment.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

   • Not applicable as there is no training set for a physical device.

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