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The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.

The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.

Endotics is an endoscopic system to be used for the examination of the final section of the intestine, the ends of which are marked by the anal sphincter and by the ileocecal valve, known as the colonrectum. The system comprises two parts, which can be sold separately, namely: the"disposable probe", and the "workstation", equipped with a command console. Thanks to its flexibility, the disposable probe can easily adapt its shape to that of the colon. The motion, based on the "caterpillar" principle, is ensured by an anchoring system, placed by the ends of a flexible body. The colonoscope includes on its distal segment a viewing system, featuring a CMOS digital camera and a LED light source. The probe is further equipped with a steering system, which enhances the efficiency in terms of both motion and vision (maximum flexion angle: 180° in every direction). The endoscope is activated pneumatically. This device allows the use of specific surgical tools through a working channel. The exit of the working channel is centred compared to the robot and it is located near the camera, which is therefore slightly decentred. When the tool exits the probe, it is immediately detected and the operator can then visually pilot it over the zone to be treated. The anchoring system performs a double action. By extracting the air from inside the intestine it enables the intestine linings to approach the robot precisely at the point in which they will then be mechanically anchored. This system produces a steady hold on the intestine lining but prevents any damage or trauma from occurring. Endotics Workstation is composed of an electro-pneumatic system, controlled by a Panel PC which displays the different progress phases of the device and the images delivered by the internal camera, and of a command console for controlling the probe's movements. Only the Endotics disposable probe can be connected to this workstation. The probe is linked to the workstation by means of an electro-pneumatic connector is placed on a twistable arm which is connected to the machine's main block. This arm is fitted on the inside with pneumatic tubes and electric cables which connect the probe to the workstation's electro-pneumatic system and which connect the camera (placed by the probe's head) to a video system. The arm is also equipped with an electronic board which acts as an opto-insulator between the camera and the electric features of the workstation. The electro-pneumatic distributor is controlled by a computerised system, on which specifically designed command software has been installed. The monitor also displays the probe's status, indicating its current motion phase e the captured pictures. The associated accessories include: Stiffening accessory, Waterjet accessory.

Here's an analysis of the acceptance criteria and study details for the Endotics device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 20 patients (Planned: 20; Analyzed: 20)
• Data Provenance: The study was a "Single center, controlled and randomized NO PROFIT study." The text does not explicitly state the country of origin, but the applicant (Era Endoscopy s.r.l.) is based in Peccioli, Italy, suggesting the study was likely conducted in Italy. The study period was "5 months from May to September 2018." This was a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the study involves a comparison with "traditional colonoscopy" to evaluate diagnostic accuracy (efficacy) in identifying colorectal diseases. This implies that the diagnosis from the traditional colonoscopy would serve as a form of ground truth, typically established by trained gastroenterologists/endoscopists performing and interpreting the colonoscopies.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method like 2+1, 3+1, or none. It describes a "Single center, controlled and randomized NO PROFIT study" comparing Endotics to traditional colonoscopy. The determination of efficacy (PDR/ADR) and adverse events would have been based on the findings during these procedures.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a clinical investigation comparing the performance of the Endotics system (a self-propelled robotic colonoscope) against traditional colonoscopy, focusing on its own efficacy, safety, and tolerability, rather than the improvement of human readers with AI assistance. The Endotics system itself is a device for performing colonoscopy, not an AI-assisted interpretation tool for human readers.

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

The Endotics System is a robotic colonoscope guided by an operator using a joystick. It is not a standalone algorithm, but a device that facilitates the human operator's performance of colonoscopy. Therefore, its performance necessarily includes human-in-the-loop operation, and a standalone algorithm-only performance assessment would not be applicable or relevant for this type of device.

7. The type of ground truth used:

The ground truth for the clinical study comparing Endotics to traditional colonoscopy would primarily be clinical findings and expert assessment during the procedures themselves. For efficacy endpoints like Polyp Detection Rate (PDR) and Adenoma Detection Rate (ADR), the findings from both Endotics and traditional colonoscopy would be compared, and ultimately confirmed through histopathology of biopsied or resected lesions. For safety, adverse events would be documented by clinical observation.

8. The Sample Size for the Training Set:

The document does not provide details about a "training set" in the context of machine learning. The Endotics device is a robotic endoscope, not an AI-based diagnostic algorithm that typically relies on large training datasets. The "development" of the device would have involved engineering design, bench testing, animal studies, and initial human clinical studies, but these are not referred to as a "training set" in the machine learning sense.

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

As there is no mention of a "training set" in the context of an AI algorithm, details on how its ground truth was established are not provided. The development and validation process focused on engineering verification and validation (bench tests, biocompatibility, electrical safety, etc.) and clinical studies to demonstrate safety and efficacy of the physical device.

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