Search Results

The DEFENDO™ Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The Byrne Medical DEFENDO™ Disposable Air/Water Valve is substantially equivalent to the Olympus® MH-438 Air/Water Valve.

The submitted document, K107409, describes the Byrne Medical DEFENDO™ Disposable Air/Water Valve and compares it to a predicate device, the Olympus® MH-438 Air/Water Valve (K001241). The primary goal of the submission appears to be to demonstrate substantial equivalence to the predicate device, rather than to prove the device meets specific acceptance criteria through a clinical study. The performance data presented focuses on comparative bench testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a clinical study. Instead, it aims to demonstrate substantial equivalence to a predicate device, which implies that its performance should be comparable to the predicate. The performance reported is from comparative testing against the predicate device for water flow.

Study Proving Acceptance Criteria:

The study proving the implied acceptance criteria is a comparative performance (bench) test.

• Study Type: Comparative Bench Testing (Water Flow Test)
• Objective: To compare the water flow rates of the Byrne Medical DEFENDO™ Disposable Air/Water Valve with the Olympus® MH-438 Air/Water Valve.

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

• Sample Size (Test Set):
  • Overall Water Flow Test: 10 Byrne Medical 100304 Air/Water valves and 10 Olympus MH-438 Air/Water valves. Measurements were taken over a time period of 0 to 40 seconds, yielding an 'n' of 188 for correlation analysis.
  • 0-7 Second Interval Water Flow Test: Although the same number of valves were likely used, the analysis focused on a shorter time period, resulting in an 'n' of 36 for correlation analysis.
• Data Provenance: The data is generated from bench testing (in-vitro performance testing) and not from human subjects. Therefore, concerns like country of origin for patient data or retrospective/prospective status are not applicable.

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

• Not Applicable. This study is a bench test comparing physical device performance (water flow) under controlled conditions. It does not involve human interpretation or subjective assessment that would require expert consensus for a "ground truth" as typically defined in diagnostic studies. The "ground truth" here is the measured performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a bench test measuring physical parameters, there is no need for an adjudication method by experts. The measurements are objective and quantitative.

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

• No. An MRMC study was not conducted. This is a bench test of physical device performance, not a study involving human readers interpreting clinical cases.

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

• No. This device is a physical medical instrument (an air/water valve), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Bench Test Measurement/Predicate Performance: The "ground truth" in this context is the measured performance of the legally marketed predicate device (Olympus® MH-438 Air/Water Valve). The Byrne Medical device's performance is compared directly against these objective measurements.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning algorithm. Hence, there is no "training set."

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

• Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

Ask a specific question about this device