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The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues: and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs: tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

These Video Duodenoscopes must be used with a PENTAX compatible Video Processor (software controlled device). The endoscopes have a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.

There is no information in the provided document about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) premarket notification letter from the FDA to PENTAX of America, Inc., regarding PENTAX Medical ED3490TK Video Duodenoscope and PENTAX Medical ED34-i10T Video Duodenoscope.

The focus of the document is on establishing substantial equivalence to a predicate device (PENTAX ED-3490TK Video Duodenoscope, K161222), primarily based on intended use, technological characteristics, and safety/effectiveness considerations, rather than detailed performance study results of the type requested.

Specifically, the document states:

• Performance Data: "No performance standards or special controls applicable to these devices have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act."
• Technological Characteristics: The differences between the subject devices and the predicate device are listed as "O-ring Thickness" and "Elevator Link Concentricity." The proposed design change to the O-ring was to demonstrate a "minimum of 10% Compression Ratio," and it is stated that "Through analysis, the modification has demonstrated a Compression Ratio that met the pre-determined acceptance criterion." This is the only mention of an acceptance criterion and its fulfillment by analysis, not by a detailed clinical or performance study with the metrics you've requested.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a regulatory clearance based on substantial equivalence, with a focus on design changes and their impact on safety and effectiveness, rather than a detailed performance study with clinical or AI-related metrics.

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The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor. The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, 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, cannula/forceps elevator control 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 cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel. The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. 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 function of video processor and external device from the control body, as necessary. The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use. 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 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 body cavity is displayed on the monitor.

This document is a 510(k) summary for the PENTAX Medical ED34-i10T Video Duodenoscope, which is a medical device and not an AI or software-only product. Therefore, much of the requested information regarding AI-specific criteria (like training set size, ground truth for training data, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract and describe the acceptance criteria and performance data provided for the device as a whole.

1. Table of Acceptance Criteria and Reported Device Performance

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