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The Pathfinder Endoscope Overtube with Balloon is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube with Balloon device consists of a hollow tube with a balloon at the distal end for use over a flexible gastrointestinal endoscope. The purpose of the balloon is to contact the lumen walls to provide stabilization to the distal end of the overtube within the GI tract. The endoscope is inserted through the proximal end of the device and comes out the distal end. The free space between the overtube and the endoscope is lubricated with water through the irrigation line by connecting to the irrigation/water Luer (female Luer lock fitting) and injecting water. The vacuum line is connected to free space within the device and is completely contained. A source of vacuum must be connected to the barb fitting per the diagram below for the overtube to transition between the flexible and rigid conditions. The balloon line is connected to an extrusion within the device that creates an air pathway from handle to the balloon. An inflation device must be connected to the Luer (male Luer lock fitting) to inflate and/or deflate the balloon. The handle rotator has two positions. The first position connects the device to atmosphere (vent) to stay in the flexible condition. The second position connects the device to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. Balloon inflation and deflation are actuated and controlled by an existing balloon controller unit within the endoscopy suite. The device must be connected to the balloon controller to transition into the inflated and deflated condition.

The provided text does not contain information about a study that proves a device meets acceptance criteria related to AI/algorithm performance.

The document is a 510(k) Premarket Notification from the FDA to Neptune Medical, Inc. for their "Pathfinder Endoscope Overtube with Balloon Device." It describes the device, its intended use, comparison to predicate devices, and summaries of functional and performance bench testing, and biocompatibility testing. It explicitly states:

• "No clinical testing was applicable to this submission."
• The entire submission focuses on a physical medical device, not an AI or algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI-powered device's performance, as the provided text pertains to a traditional medical device not involving AI.

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The Lumendi DiLumen C² is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C2 consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is intended only for single patient use.

To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surqical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling.

The provided text is a 510(k) summary for a medical device (DiLumen C2 and Tool Mount) and thus focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description of how acceptance criteria were met for a novel AI/software device. Consequently, many of the requested details about acceptance criteria, study design for AI models, ground truth, and expert involvement are not applicable or available in this document.

However, I can extract the general "performance data" that was provided to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not explicitly state quantitative acceptance criteria for each. Instead, it generally states that the device "meets specifications" and "functioned as intended."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not applicable as this is a physical medical device, not an AI/software device generating data. The testing would have been conducted on physical units of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a physical device submission; ground truth in the context of expert consensus for AI models is not relevant here. "User Verification Testing" implies evaluation by users/clinicians, but specific numbers or qualifications are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is a physical device.

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:

• Not applicable. This is a physical device, not an AI or software product that assists human readers.

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

• Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the context of AI/software ground truth. For a physical device, "ground truth" would refer to established engineering and performance specifications and industry standards for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/software product requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is a physical device.

Study that proves the device meets the acceptance criteria:

The document states: "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope."

The specific studies performed were:

1. Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
2. Fore and Aft Balloon Diameter
3. Therapeutic Zone Creation
4. Balloon/Endoscope Centering
5. Endoscope Insertion Force
6. Instrument Insertion and Removal Force
7. Tool Channel Deflection
8. User Verification Testing

The conclusion is that "In all instances, the device functioned as intended and the results observed were as expected," supporting its substantial equivalence to the predicate device. The details of these "bench tests" are not provided in this summary.

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