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The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.

The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.

The provided text describes the ENTity WiFi Video Nasopharyngoscope System and its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets particular clinical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for identifying specific conditions). The document focuses on showing substantial equivalence based on technical characteristics, non-clinical performance data, and compliance with various engineering and safety standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I detail a study that proves such criteria were met, as that information is not present in the provided text.

I can, however, extract information about the non-clinical performance and testing performed to demonstrate safety and technical equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a table with clinical acceptance criteria (e.g., diagnostic sensitivity/specificity) and corresponding device performance data for ENTity WiFi Video Nasopharyngoscope System. Instead, it lists technical features and compliance with standards.

Here's a table based on the technical comparison and performance verification mentioned, rather than clinical acceptance criteria for diagnostic efficacy.

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

The document primarily describes non-clinical performance testing and compliance with standards. It does not specify sample sizes for test sets related to human data or diagnostic performance. Details like country of origin or retrospective/prospective nature are not provided for the described tests, as they are largely engineering and bench testing rather than clinical trials.

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 in the document because it does not detail a study involving expert-established ground truth for diagnostic accuracy. The testing described is overwhelmingly technical and engineering-focused.

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

This information is not provided as there is no described clinical study involving human judgment and adjudication.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI assistance in the context of this device. The device is a "Video Nasopharyngoscope System," implying a direct visualization tool, not an AI-powered diagnostic system.

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

This information is not applicable as the device described is a video nasopharyngoscope system for direct visualization, not an algorithm or AI system for standalone performance evaluation.

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

For the non-clinical performance and safety testing, the "ground truth" was established by engineering specifications, recognized consensus standards, and guidance documents. For example, the ground truth for biocompatibility was adherence to ISO 10993-1, and for electrical safety, it was compliance with IEC 60601-1. There is no mention of clinical ground truth (e.g., pathology, outcomes data) as this document focuses on technical and safety equivalence.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.

This 510(k) submission (K130489) is for a design and labeling change to an existing device, the PRECISION Endoscopic Infrared Coagulator™ with SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE. The submission explicitly states that there are no technology differences between the submission device and its predicate devices, and no changes to the intended use or indications for use.

Therefore, the study performed is focused on demonstrating that the design changes do not affect the safety and effectiveness of the device, rather than proving performance against new acceptance criteria for a novel technology.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a design change with no technological differences or changes to intended use, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness profile of the predicate devices. The reported performance is verification that these standards are maintained.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a quantitative sample size for the "bench testing" performed. It generally states that "Verification testing results for the design changes were completed and all tests passed."

• Sample Size: Not explicitly stated (likely refers to a number of test articles/units for bench testing).
• Data Provenance: The testing was "Bench testing," implying it was conducted in a laboratory or engineering setting by the manufacturer (Optim LLC in Sturbridge, MA). It is retrospective in the sense that it's verifying changes to an existing design, not gathering new clinical data on patients.

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 to this 510(k) submission.

• This submission is not for an AI/ML device, diagnostic device, or a device that requires human interpretation of outputs to establish ground truth.
• The "verification testing" described is bench testing, which assesses engineering and functional performance against defined specifications, not against expert-established ground truth related to clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above. There's no interpretive test set requiring adjudication.

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

Not applicable. This device is an infrared coagulator, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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 with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is typically defined by engineering specifications, established performance parameters of the predicate device, and compliance with relevant consensus standards. For example, ground truth for power output might be a specific wattage as measured by calibrated equipment, or ground truth for light guide flexibility might be its ability to withstand a certain bend radius without damage. The document indicates verification was against the safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device that requires a training set.

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