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The EndoGator™ system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

The Byrne Medical EndoGator™ System is composed of the following:

• 1. EndoGator™ Irrigation Tubing, and
• 2. EndoGator™ Irrigation Accessories

The EndoGator™ System consists of a bottle cap/tube set/connector made from materials that are appropriate for the application. The EndoGator™ Cartridge is a replacement for some predicate device water systems.

The provided text describes a 510(k) premarket notification for the “EndoGator™ System,” a device intended to provide irrigation during GI endoscopic procedures. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the requested elements for a detailed study description are not available in the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

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

Explanation: The document does not specify quantitative acceptance criteria (e.g., minimum flow rate, maximum pressure deviation). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing legally marketed devices (predicates). The reported performance is a qualitative statement that the device was tested for flow and pressure and found to be functionally equivalent.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document only states "representative scopes" were used for flow and pressure testing.
• Data Provenance: Not specified, but likely internal testing by Byrne Medical, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The ground truth for this type of device (a water bottle adapter for irrigation) is physical performance (flow, pressure, material compatibility) rather than diagnostic accuracy requiring expert interpretation.

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

Not applicable. No expert adjudication process is described or implied for the performance testing of this mechanical 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

Not applicable. This device is not an AI-powered diagnostic or assistive tool, so an MRMC comparative effectiveness study involving human readers and AI is irrelevant.

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

Not applicable. This is a mechanical accessory, not an algorithm.

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

The "ground truth" for the performance testing would be established engineering standards and validated measurement techniques for flow rate and pressure, combined with material science evaluations. The document refers to "extensive safety, performance, and validations" and "real-time flow rate data was collected," indicating a focus on physical performance rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

Not applicable. (See #8)

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