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The PENTAX Medical Video Esophagoscope EE17-J10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems of esophagus and gastro-esophageal junction.

This endoscope is introduced via the mouth or nose when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

The PENTAX Medical Video Esophagoscope EE17-J10 is intended to be used with a PENTAX Video Processor, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the esophagus and Gastro-Esophageal Junction. This anatomy includes, the following organs, tissues; and subsystems: Esophagus and Gastro-Esophageal Junction.

The EE17-J10 is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion is inserted into the body cavity of patient. The insertion portion includes the distal end and bending section. The objective lens, light guide, instrument channel and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts.

The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob.

The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned.

The remote button is used to operate the functions of the video processor and any external device from the control body, as necessary.

Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel.

The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guides the light from light guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the monitor.

The PENTAX Medical Video Processors EPK-i7010 and EPK-3000 are compatible with PENTAX Medical Video Esophagoscope EE17-J10.

The PENTAX Medical Video Esophagoscope EE17-J10 is provided with the following accessories:

• Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
• Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
• Suction Control Valve - intended to control suction.
• Air/Water Valve - intended to control air and water feeding.

Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O-Rings.

The provided text does not contain detailed acceptance criteria or a comprehensive study report for the device's clinical performance. Instead, it focuses on non-clinical performance data and a brief mention of a "clinical image capture study."

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table specifying distinct acceptance criteria for clinical performance and corresponding reported device performance metrics. It mainly lists validation studies for non-clinical aspects and states that "All acceptance criteria were satisfied" for reprocessing validation.

For the "Optical Performance" and "Clinical Image Capture Study," it claims equivalence or demonstration of capability rather than specific quantitative performance against acceptance criteria.

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

• Clinical Image Capture Study: The document states that "A clinical image capture study was performed," but it does not specify the sample size (e.g., number of patients or cases) used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used to establish ground truth for the clinical image capture study, nor their qualifications.

4. Adjudication Method

• The document does not specify any adjudication method used for the clinical image capture study's ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study. The document does not discuss human reader improvement with or without AI assistance, as the device described is an esophagoscope and not an AI-powered diagnostic tool in the typical sense that would involve such a study.

6. Standalone (Algorithm Only) Performance

• This question is not applicable as the device is an esophagoscope, a medical instrument for direct visualization, not an algorithm for standalone diagnostic performance.

7. Type of Ground Truth Used

• For the "Clinical Image Capture Study," the document states it was performed "to demonstrate the maneuverability of the EE17-J10 endoscope and its ability to capture images at each of the pre-determined anatomical areas when used in a clinical setting." This suggests the ground truth was based on the successful visualization and image capture of anatomical areas by a clinician, rather than expert consensus on a diagnosis, pathology, or outcomes data.

8. Sample Size for the Training Set

• This question is not applicable as the device is an esophagoscope and does not appear to involve a "training set" in the context of machine learning or AI algorithms. The "reference device" EG17-J10 (K210177) is used for comparison in performance, not as a training set for the current device's development.

9. How Ground Truth for the Training Set Was Established

• This question is not applicable for the same reason as point 8; there is no mention of a "training set" with established ground truth for this medical device's clearance.

In summary, the provided text details non-clinical performance evaluations (reprocessing, biocompatibility, software/cybersecurity, electrical safety, system performance, optical performance) focused on establishing substantial equivalence to a predicate and reference device. However, it lacks specific details regarding quantitative clinical performance, acceptance criteria, sample sizes, expert involvement, or ground truth establishment for a clinical study that would directly address device effectiveness in a diagnostic or therapeutic context. The "Clinical Image Capture Study" is mentioned as merely demonstrating the device's ability to capture images in clinical settings.

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