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The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least18 years of age.

The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories.

1. Ingestible PillCam Capsule: The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the PillCam Recorder located outside the body.
2. DR 3 PillCam Recorder: DR 3 PillCam Recorder is an external The receiving/recording unit that receives and stores the acquired images from the capsule.
3. RAPID Software: The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms. RAPID 8.0 supports PillCam capsule endoscopy of the GI tract with all PillCam video capsules. In addition, RAPID 8.0 supports PillCam Recorder DR 2C and PillCam Recorder DR 3.
4. Given Workstation and Accessories: The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The PillCam Recorder is an external receiving/recording unit that receives acquired images from the capsule. The Sensor Array receives data from the PillCam capsule and transfers the data to the PillCam Recorder. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.

This document describes the Given PillCam UGI capsule endoscopy system. The provided text outlines the device's indications for use, general description, technological characteristics, and a brief statement on how it meets guidance. However, it does not contain specific details from a study proving the device meets acceptance criteria, nor does it provide a table of acceptance criteria with reported device performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to predicate devices, discussing:

• Device Name: Given PillCam UGI capsule endoscopy system
• Intended Use: Visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum), including visualization of blood, in hemodynamically stable patients at least 18 years of age.
• Components: Ingestible PillCam capsule, DR 3 PillCam Recorder, RAPID software, and Given Workstation and Accessories.
• Technological Characteristics: Similar to predicate devices (ESO 2, ESO 3, COLON 2 capsules). Modifications include prolonged operation time and adaptive frame rate (35 fps for 10 minutes, then 18 fps for 80 minutes) to achieve better upper GI tissue coverage. optical features include 4 white LEDs, 172° field of view, and 0-30mm effective visibility distance.
• Bench Testing: Biting test and pH resistance test from the COLON 2 capsule (predicate) are applicable due to identical external components and technology. Optical resolution testing showed pH environments do not affect optical performance.
• Compliance: The device meets the "Class II Special Controls Guidance Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001."

The document concludes that the modifications "do not raise new performance or safety issues" and that the system is substantially equivalent to predicate devices. This implies that the performance is considered acceptable based on its similarity to previously approved devices, rather than through a dedicated performance study with specific acceptance criteria detailed in this summary.

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