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The provided text describes a 510(k) premarket notification for an "Irrigation Channel Tubing System" (Model 100135) by Byrne Medical, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics as would typically be found in an AI/software device submission.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable to this type of regulatory submission. This document describes a physical medical device, not a software algorithm.

However, I can extract the relevant information regarding the testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data. The testing described is bench testing of the physical device.

• Sample Size: Not explicitly stated how many units were tested for flow and pressure, nor how many "pump cycles" were performed. It generally refers to "the system" being tested.
• Data Provenance: N/A (Bench testing, not human data).

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

N/A. This was bench testing of a physical device, not an AI/software device requiring expert-established ground truth for interpretation.

4. Adjudication Method for the Test Set

N/A. This was bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This was bench testing of a physical device, not an AI/software device. No human readers or comparison with/without AI assistance was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

N/A. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench tests was derived from empirical measurements against engineering specifications and the performance of the known predicate devices.

• Flow Rate: Measured volume over time.
• Pressure: Observation of leaks/failures.

8. The Sample Size for the Training Set

N/A. This is a physical device, not an algorithm or AI model that requires a training set.

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

N/A. Not applicable as there is no training set for a physical device.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study described is bench testing conducted by Byrne Medical, Inc. on their Irrigation Channel Tubing System, Model 100135.

• Testing Method:
  • Bench testing utilized Meditron UGI-3000B™ GI Endoscopy Pumps and EndoGator™ Cartridge and tubing sets.
  • Flow testing: Measured total volume over time at minimum and maximum pump settings.
  • Pressure testing: The system was tested to a pressure of 10 PSI.
• Results:
  • Flow testing demonstrated flow rates of 155 ml/min at the minimum pump setting and 650 ml/min at the maximum pump setting, with a measurement error of +/- 4%.
  • Pressure testing showed the system withstood 10 PSI without leaking or any other failure, exceeding the pump manufacturer's stated maximum pressure of 4.4 PSI.
• Conclusion: Based on these bench tests, the manufacturer concluded that the Byrne Medical Endo Gator™ Irrigation Channel Tubing system is equivalent in safety and efficacy to its predicate devices.

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