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The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.

The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.

The provided text describes the 510(k) premarket notification for the "Irrigation Tubing with CO2 or Air" device, demonstrating its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in an AI/ML medical device submission.

The document pertains to an irrigation tubing device, which is a simple medical device, and not an AI/ML-driven device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC study, training set sample size, etc.) are not applicable to this type of submission.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions "established internal acceptance criteria based on ISO 14971:2012" for risk analysis, and "design verification and validation" for performance. It also lists specific tests conducted. However, it does not provide a table detailing quantitative acceptance criteria (e.g., specific flow rates, leak tolerances) and the corresponding measured performance values.

Partial Information Available:

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

• Sample Size for Test Set: Not specified. The document mentions "benchtop testing" and "usability evaluation" but does not quantify the number of units or test iterations.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For the performance testing bench, it refers to internal testing by KeyMed.

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

This information is not applicable. This device is not an AI/ML device that requires expert-established ground truth for performance evaluation in the typical sense. Performance is assessed through engineering and physical tests.

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

Not applicable, as this is not an AI/ML device requiring human adjudication of performance.

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 not an AI/ML product.

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

Not applicable. This device does not involve an algorithm.

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

Not applicable in the context of clinical ground truth for an AI/ML device. For this physical device, "ground truth" would be established through engineering specifications, material properties, and physical measurements against defined standards.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML device and does not have a training set.

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

Not applicable. This device is not an AI/ML device.

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