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The DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

The DEFENDO™Y-Opsy Irrigator is a sterile, disposable, single patient use, biopsy valve with a side port backflow valve for irrigation. It provides access for endoscopic device passage, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy channel during endoscopic procedures. The backflow valve prevents the potential of cross contamination between patients the device's diaphragm (slit) minimizes leakage from the biopsv channel while reducing the healthcare professional's exposure to biomaterials as endoscopy instruments are withdrawn.

Here's an analysis of the acceptance criteria and supporting studies for the DEFENDO™ Y-Opsy Irrigator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative bench testing rather than defining explicit acceptance criteria for novel performance claims. The "acceptance criteria" are implied by the performance of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Flow Rate Study: The sample size for the devices tested in the flow rate study is not explicitly stated, only that it utilized "two separate manufacturers' endoscopes." The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
• Functional Criteria Study: The sample size for the devices tested in the functional criteria study is not explicitly stated. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
• Leak Testing: The sample size for the leak testing is described as "100% of the DEFENDO™ Y-Opsy Irrigators tested." The exact number (e.g., N=X) is not provided, but implies a comprehensive test of a batch. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
• Country of Origin: Not specified but implicitly conducted by Byrne Medical Inc. in Conroe, Texas, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This device is a medical accessory, and the "ground truth" for its performance is established through measurable physical properties (flow rate, leakage, functional criteria) through bench testing, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the evaluation is based on objective bench testing measurements, not expert review or adjudication of subjective data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic imaging device or an AI-assisted device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device, not an algorithm or software. The performance studies are standalone to the device itself.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Predicate Device Performance: The established performance characteristics of the legally marketed predicate devices (Byrne Medical Endogator® System Y-Connector and Byrne Medical DEFENDO™ Biopsy Valve).
• Objective Bench Test Measurements: Quantifiable measurements such as flow rate (volume over time) and pressure capabilities, as well as qualitative assessments of functional equivalence during simulated use.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of device.

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