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The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.

The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.

The provided text describes the EndoLok™ device and its review by the FDA. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance in the format requested, nor does it describe a study involving specific performance metrics, sample sizes, expert involvement, or AI.

Here's an analysis of what is available and what is missing:

Available Information:

• Device Name: EndoLok™
• Intended Use: "indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy."
• Predicate Device: EndoEase Advantage™ for Colonoscopy (K062805)
• Performance Data Summary: "Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test to demonstrate safety and effectiveness. All test samples met each test criterion. The device was determined to be safe and effective for its intended use."
• FDA Determination: Substantially Equivalent (SE) to the predicate device.

Missing Information (Crucial for requested table and study details):

• Specific Acceptance Criteria: The document states "All test samples met each test criterion" but does not list what those criteria were.
• Reported Device Performance against Criteria: Since the criteria aren't detailed, the specific performance values (e.g., specific grip strength in Newtons, precise friction coefficient, angular range) are also not provided.
• Details of the "9-point bench test": The nature of these 9 points is not elaborated upon.
• Sample size for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details (effect size, AI assistance).
• Standalone algorithm performance study details (AI without human-in-the-loop).
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Based on the provided text, here's what can be deduced, and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified. The document states "Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test." The exact number of samples is not provided.
• Data Provenance: The device manufacturer, Syntheon LLC, is based in Miami, Florida, USA. The testing was a "bench test," implying laboratory conditions rather than patient data from a specific country or clinical setting. It is inherently prospective as the device was manufactured and then tested.

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

• Not applicable / Not provided. This was a bench test of a physical medical device (a handle for a colonoscope), not an AI/imaging diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

• Not applicable / Not provided. As this was a bench test against predefined criteria, an adjudication method for conflicting expert opinions (as in image interpretation) would not be relevant. The "adjudication" was likely whether the test sample met the objective test criterion.

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. This document describes a K080317 510(k) submission for a physical medical device (colonoscope handle), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or described.

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

• No. This device is a physical handle, not an algorithm. Therefore, standalone algorithm performance is not relevant or described.

7. The type of ground truth used:

• Objective Bench Test Criteria. The "ground truth" for this device's performance was whether it met the predefined technical specifications and performance characteristics established for the "9-point bench test." These would likely be engineering or physical metrics related to grip, force, durability, etc.

8. The sample size for the training set:

• Not applicable / Not provided. This device is a physical, non-AI medical device; therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML model development.

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

• Not applicable / Not provided. As there is no AI/ML training set, this question is not relevant.

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