Search Results

The Pathfinder Endoscope Cap is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

The Pathfinder Endoscope Cap is single-use distal attachment for endoscopes. It is an aid to endoscopic visualization and treatment in the gastrointestinal (GI) tract. The Pathfinder Endoscope Cap consists of a single piece of Pebax® in a symmetrical, tapering shape for placement on the distal tip of an endoscope. It is a short, transparent tube with an attaching portion used to connect the cap to an applicable endoscope, a distal portion that tapers into a narrower diameter opening, and a side hole for drainage to prevent fluids lodging on the surface of the endoscope. The device is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection in the GI tract.

The Pathfinder Endoscope Cap has the following physical and performance characteristics:

• Sterilized by ethylene oxide
• For single use
• Tapering distal tip
• Soft stop (tactile indicator of correct depth position)
• Compatible with endoscopes with 11.7 mm outer diameter distal ends, such as the Olympus PCF-H180A and PCF-H190
• Compatible with the Pathfinder Endoscope Overtube, which is intended for use with the same size endoscopes.

The provided text describes the 510(k) premarket notification for the "Pathfinder Endoscope Cap" and its substantial equivalence comparison to a predicate device. However, it does not include the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or reader improvement with AI.

The document focuses on the Pathfinder Endoscope Cap's physical characteristics, materials, and a comparison with a predicate device based on general technological and performance criteria. It also mentions mechanical testing and biocompatibility testing.

Here's a breakdown of what is and is not in the provided text, structured as requested:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the text. The document states that the device underwent "mechanical testing" and "biocompatibility evaluation," but it does not list specific acceptance criteria (e.g., minimum tensile strength, maximum tracking force) or the quantitative results from these tests. It only lists the types of tests performed.

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

This information is not provided in the text. The document mentions "mechanical testing" and "biocompatibility evaluation" but gives no details about the sample sizes used for these tests or the origin of any data.

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

This information is not provided in the text. The device is a physical endoscope cap, not an AI or diagnostic tool that would typically involve expert ground truth for performance evaluation in the context of medical image analysis.

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

This information is not provided in the text. Similar to point 3, this type of method is relevant for expert-based evaluation of diagnostic or AI performance, which is not described for this 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:

This information is not provided in the text. The device is a physical endoscope cap, not an AI system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and not mentioned.

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

This information is not provided in the text. As noted, this is a physical device, not an algorithm.

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

This information is not provided in the text. Given the device is a physical cap, typical "ground truth" as applied to diagnostic or AI performance evaluation (e.g., pathology, expert consensus) would not be relevant. The "ground truth" for its performance would likely be engineering specifications and functional testing results (e.g., does it fit correctly, does it maintain integrity during use), but these specific details are not elaborated.

8. The sample size for the training set:

This information is not provided in the text. Since this is not an AI device, there is no "training set."

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

This information is not provided in the text. As above, this is not an AI device, so this concept is not applicable.

Summary of available information regarding the "study" for the Pathfinder Endoscope Cap:

The document describes the following types of testing that were performed:

• Mechanical Testing:
  • Dimensional and visual testing
  • Cap tracking force (through compatible overtube)
  • Cap tensile strength with tape
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and relevant standards.
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic Toxicity

The stated conclusion (Section 1.10) is: "The enclosed biocompatibility and performance testing results demonstrate that the subject device is safe and effective for its intended use and substantially equivalent to the predicate."

However, the specific quantitative results of these tests and the acceptance criteria that those results met are not detailed in the provided FDA letters and summary. This document primarily serves as a notification of a 510(k) clearance and outlines the general characteristics and comparison to a predicate device, rather than a detailed study report.

Ask a specific question about this device