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The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.

The provided text describes the ENDOGATOR™ Hybrid Irrigation Tubing, a device for providing irrigation and supplying air/CO2 during GI endoscopic procedures. It compares this device to a predicate device (Universal Irrigation Solution Hybrid, K102855).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance

Biocompatibility Testing:

• Requirements: Evaluated in accordance with ISO 10993-1:2018 for "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)".
• Tests Performed: Cytotoxicity, Irritation, and Sensitization.
• Reported Device Performance: All evaluation acceptance criteria were met.

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

The document does not explicitly state the sample size for the test set for any of the performance tests. It only lists the tests performed and their outcomes ("Pass").

The data provenance is presented as "Non-clinical testing", which implies lab or bench testing rather than clinical data from human subjects. The document does not specify the country of origin of the data; however, Medivators Inc. is located in Minneapolis, Minnesota, USA, which suggests the testing was likely conducted in the US or under US regulatory standards. The data is retrospective in nature, as it was provided to support a 510(k) premarket notification.

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 medical device (tubing and accessories) that does not involve algorithmic or diagnostic assessment requiring expert ground truth for its performance evaluation (e.g., image interpretation). The performance data cited are objective engineering and material testing results (e.g., flow rates, pressure resistance, pull force, biocompatibility).

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

Not applicable. As described above, the performance tests for this device are objective physical and chemical evaluations, not subjective assessments requiring expert adjudication.

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 device is a piece of medical tubing and accessories, not an AI or diagnostic imaging system. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device is not an algorithm or AI system.

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

For the performance tests:

• Water Flow Rate, Insufflation Air & CO2 Flow, Lens Rinsing Flow Rate: Measured values against predefined thresholds relative to the predicate device.
• Backflow Test: Pressure resistance measurement (withstanding at least 10 PSI).
• Durability of glue bonded connections: Axial pull force measurement (meeting or exceeding 10 lbs) and strength/durability requirements after sterilization.
• Biocompatibility: Conformance to ISO 10993-1:2018 standards, evaluated via specific laboratory tests (Cytotoxicity, Irritation, Sensitization).

The "ground truth" here is the objective measurement against established physical and biological standards and performance relative to the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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