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The Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older).

It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics and doctors' offices.

The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices. The Pathfinder® CR System consists of the following main components: Suction Adapter (CR, Adapter), Foot Pedal (Suction Controller), Suction Tubing (Tubing).

The provided FDA 510(k) summary for the Neptune Medical Pathfinder® CR System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, and non-clinical functional and performance testing. It explicitly states that "No clinical testing was applicable to this submission" and "No animal testing was applicable to this submission." Therefore, the document does not contain information about a study with acceptance criteria of the type requested, which would typically involve human-in-the-loop performance or standalone algorithm performance.

However, based on the provided text, I can infer the "acceptance criteria" are related to successful functional and performance testing and biocompatibility, rather than a clinical performance study with metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document describes several non-clinical functional and performance tests. While specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values, the overall conclusion states that the device "successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness."

To provide a table as requested, I'll interpret the successful completion of each test as meeting an implicit acceptance criterion.

Regarding the specific questions about evaluation studies:

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

• Not applicable / Information not provided. This document details non-clinical (bench) testing, not a clinical study involving a test set of patient data.

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

• Not applicable. No expert review of a "test set" to establish ground truth is described, as there was no clinical study.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication method is described.

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:

• No. The document explicitly states, "No clinical testing was applicable to this submission." This device is a mechanical system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

• Not applicable. This device is a mechanical system, not an algorithm. The testing described is functional performance testing of the device itself.

7. The type of ground truth used:

• Bench Test Specifications / Engineering Requirements. For the functional tests, the "ground truth" would be the engineering specifications and design requirements against which the device's performance was measured. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This pertains to algorithm development. This device is a mechanical system.

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

• Not applicable. This pertains to algorithm development. This device is a mechanical system.

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