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The BACSTOP™ dental waterline Anti-retraction valve is normally closed disposable valve, which is replaced every week, or 5 working days. It is intended to be used in-line on dental unit water lines as a means of preventing the retraction of orally contaminated fluids into the coolant and irrigant water hoses. It is to be used for all patients.

BACSTOP™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water syringe or ultra sonic scaler. It opens only under sufficient pressure (equivalent to 1.5 psi) and snaps closed and seals against backflow when the pressure drops below this point. The device is inserted by connection to luer mounts placed permanently in-line.

BacStop™ valve is a weekly disposable, normally closed antiretraction check valve, consisting of a flat silastic rubber disc valve membrane in a housing made up of top and bottom parts, united by a sonically sealed joint. The two parts of the valve housing are made of clear Lexan 124R Polycarbonate, with the top (entry) port being in the form of a female Luer fitting, and the bottom (exit) port being in the form of a male Luer fitting, with locking collar. Total length of the device is 0.93 inches, width 0.5 inches. The nominal cracking (opening) pressure for the check-valve is 1.5 psi.

Here's an analysis of the provided text regarding the BACSTOP™ VALVE, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The test set used 6 valves. The data provenance is not explicitly stated in terms of country of origin but is from a non-clinical performance test, implying a laboratory setting rather than a human study. The study appears to be prospective as it involves the testing of the devices' capacity to prevent backflow over a specified period of use.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be based on direct measurement of fluid retraction and bacterial contamination in a controlled laboratory environment.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as human experts were not involved in establishing the ground truth. The evaluation was based on direct measurement of physical parameters.

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

No MRMC study was performed. This device is a mechanical valve, not an AI or imaging device involving human readers.

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

Yes, a standalone performance test was done, as the device's function was evaluated directly under controlled laboratory conditions without human interaction in its primary function of preventing backflow.

7. The Type of Ground Truth Used

The ground truth used was based on direct quantitative measurement of fluid retraction and bacterial contamination in a controlled laboratory setting. Specifically, it involved measuring the volume of fluid withdrawn into the waterline and implicitly, the presence or absence of bacterial markers in that withdrawn fluid (indicated by the "99.975% reduction in contamination").

8. The Sample Size for the Training Set

There is no mention of a training set. This is a physical device, and its performance is evaluated through direct testing rather than through machine learning or AI models that typically require training data.

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

Since there is no training set mentioned, there is no information on how its ground truth would have been established.

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