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The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece that is compatible with most commercially available endoscopic video systems.

The provided text describes the Entellus Medical Flexible Endoscope and Eyepiece. However, it does not contain a detailed study report that includes specific acceptance criteria and a comprehensive study proving the device meets those criteria, as typically found in a clinical trial or performance efficacy study.

The document mainly focuses on regulatory aspects for a 510(k) submission, confirming substantial equivalence to predicate devices based on general performance data.

Here's a breakdown of the information that is and is not available based on your request:

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

• Acceptance Criteria: Not explicitly stated in a quantitative, measurable format (e.g., minimum resolution, specific illumination levels, durability cycles). The document broadly states "the device meets its established specifications," but these specifications are not detailed.
• Reported Device Performance: The document states that "The device performance test data is provided in the 510(k) submission included biocompatibility testing, dimensional verification, bench testing, and qualification of reprocessing procedures. The performance data demonstrates that the device meets its established specifications, is biocompatible, and is able to perform as intended following standard reprocessing procedures."
  • Specifics are lacking. We know what types of tests were done (biocompatibility, dimensional, bench, reprocessing), but not the results or the numeric targets for those tests.

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

• This information is not provided. The 510(k) summary does not detail the sample sizes for any tests, nor does it specify if the data was retrospective or prospective, or its country of origin.

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)

• This information is not provided. The document describes a "device performance test data" but does not mention any expert review or ground truth establishment relevant to diagnostic accuracy. This type of device (an endoscope) is a visualization tool, and its performance evaluation would typically focus on aspects like image quality, illumination, field of view, and durability, rather than diagnostic accuracy established by experts on a test set.

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

• This information is not provided. As no expert review or diagnostic study is mentioned, adjudication methods for ground truth would not be applicable.

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, an MRMC comparative effectiveness study was not done. The device described is a basic flexible endoscope, a visualization tool. It does not incorporate AI, nor is it a diagnostic aid that would typically be evaluated in an MRMC study comparing human performance with and without AI assistance.

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

• No, a standalone algorithm performance study was not done. The device is a physical endoscope, not a software algorithm.

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

• This information is not applicable/provided. The performance data mentioned (biocompatibility, dimensional, bench, reprocessing) for a viewing device like an endoscope does not typically rely on "ground truth" derived from expert consensus, pathology, or outcomes data in the same way an AI diagnostic tool would. Its performance is about its physical and functional integrity.

8. The sample size for the training set

• This information is not applicable/provided. As the device is a physical endoscope and not an AI algorithm, there is no "training set" in the context of machine learning.

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

• This information is not applicable/provided. See point 8.

In summary:

The provided 510(k) summary for the Entellus Medical Flexible Endoscope and Eyepiece details a regulatory submission for a physical medical device (an endoscope). It asserts that performance testing (biocompatibility, dimensional, bench, reprocessing) was conducted and demonstrated that the device meets its specifications and performs as intended. However, the document does not provide the specific quantitative acceptance criteria or detailed results of these tests, nor does it describe studies involving expert readers, AI algorithms, or "ground truth" establishment as you've requested, because these types of studies are typically not relevant for this class and type of device. The clearance is based on substantial equivalence to predicate devices, supported by general performance and safety data.

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