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The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.

VenSure™ LightGuide is a sterile, single-use device designed to emit light from the distal end. The device is an accessory to the VenSure™ Balloon device and used to locate, illuminate within and transilluminate across nasal and sinus structures. The device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source. When activated, the light fiber will emit red light from the distal tip for two (2) hours. It has a fiber nominal working length of 20mm (0.79 inch) with an outer diameter of 0.5mm (0.02 inch). The VenSure™ LightGuide is packaged separately.

The provided text describes the VenSure™ LightGuide, a manual surgical instrument for ear, nose, and throat procedures. However, the document does not contain any information about an AI/algorithm component or a study involving human readers or expert ground truth for diagnostic purposes. The device described is a physical medical tool (a light guide), not an AI-powered diagnostic or assistive tool.

Therefore, I cannot provide details on:

• Acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
• Any study data related to AI performance, human reader improvement with AI assistance, or standalone algorithm performance.
• Sample sizes for test or training sets related to AI.
• Number/qualifications of experts, adjudication methods, or types of ground truth for an AI study.

The document focuses on the substantial equivalence of the VenSure™ LightGuide to a predicate device (PathAssist LED Light Fiber) based on:

• Intended use
• Technological characteristics
• Bench testing (mechanical integrity, light output, electrical safety, etc.)
• Biocompatibility
• Sterilization & Stability
• Electromagnetic compatibility and Electrical Safety

It states that "All tests met the predefined acceptance criteria" for these engineering and safety-related characteristics, but it does not specify what those numerical acceptance criteria were for each test.

Summary of what CAN be extracted (related to the physical device, not AI):

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests, biocompatibility, sterilization, and electrical safety. However, specific numeric acceptance criteria (e.g., minimum light output in lumens, specific force in Newtons, etc.) and the exact measured performance values are not provided in this regulatory summary.

2. Sample size and Data Provenance: Not applicable to an AI study, and specific sample sizes for the engineering tests mentioned (e.g., how many devices were tested for light output) are not disclosed in this summary. The data provenance is a regulatory submission to the FDA for a medical device cleared in the US.

3. Number of experts and Qualifications: Not applicable, as this is not an AI diagnostic study.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable.

6. Standalone Algorithm Performance: Not applicable.

7. Type of Ground Truth Used: Not applicable. The "ground truth" for this device would be defined by engineering specifications, material standards, and safety standards, not clinical diagnostic accuracy based on expert consensus or pathology.

8. Sample size for training set: Not applicable.

9. How the ground truth for training set was established: Not applicable.

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