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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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