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BACSTOP is intended for use in dental unit waterlines as a means of preventing the retraction of orally contaminated finids into the coolant and irrigant water hoses. The unit is intended to be used for one day only, and is then to be discarded, and replaced daily.

Device Description

BACSTOP is a disposable, normally closed Anti-retraction 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. Nominal Cracking (Opening) pressure for the valve is 1.5 PSI.

AI/ML Overview

The provided text is a 510(k) summary for the BACSTOP Valve and describes non-clinical performance testing. It does not contain information about clinical studies with human participants. Therefore, I will respond to your request based on the non-clinical performance testing described.

Here's an analysis of the provided text in relation to your questions regarding acceptance criteria and the study proving the device meets them:

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

Acceptance Criteria (Implied)	Reported Device Performance (BACSTOP Valve)
Prevent backflow of orally contaminated fluids into dental waterlines.	Effective in preventing backflow: "Both devices [BACSTOP and Aseptico] were effective in preventing backflow of an aqueous suspension of a marker bacterium, Chromobacterium (ATCC # 553), into dental PVC hoses connected to either high speed handpieces or air/water syringes."
No detectable bacteria in growth broth after challenge.	No bacterial growth: "No bacteria grew from water samples collected with either the Aseptico device or the BACSTOP valve in place."
Maintain performance after repeated on/off cycling (simulating one day's use).	Maintains performance: "Again, both devices were equivalent in completely preventing backflow of the challenge suspension of bacteria into the waterlines," after "250 five-second pulses of water flow at 35 PSI" (air/water syringe) or "50 twenty-second pulses" (handpiece).
Permit no backflow (zero microliters) during its normal working life (one day).	Zero microliters backflow: "BACSTOP, by comparison, permits no backflow (zero microliters) during its normal working life (one day)." This implicitly relies on the non-failure of the valve over this period and the daily disposal preventing biofilm formation. The experiments confirmed this by showing no bacterial growth after a simulated single day's use.
Biocompatibility as per USP Class VI and other tests.	Satisfactory biocompatibility: "Safety testing of the silastic rubber and polycarbonate polymer component parts of BACSTOP has included USP Class VI in vivo and in vitro biological reactivity testing, 24 Hour MEM elution test in vitro, hemolysis extract test, in vivo irritation, sensitisation, mutagenicity, and subchronic toxicity tests; all gave satisfactory results (see enclosed report)."

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical laboratory test focused on the ability of the BACSTOP valve to prevent backflow of a bacterial suspension, simulating its intended use in dental waterlines.

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 for Test Set: The text does not specify the exact number of BACSTOP valves or Aseptico valves tested in each experiment. It refers to "Both devices" and "BACSTOP valves" in plural, implying more than one, but a specific number is not provided for the backflow tests or the cycling tests.
Data Provenance: The study is reported as "Non-clinical Performance Testing" and "Non-clinical Laboratory Tests." This implies prospective testing specifically designed to evaluate the device's performance. The country of origin of the data is not explicitly stated, but the submission is from "SciTech Dental, Inc., Seattle, WA 98104," suggesting it's likely US-based.

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. This was a non-clinical laboratory study involving bacterial growth and flow dynamics, not human interpretation or assessment. Therefore, no "experts" in the sense of medical professionals were used to establish ground truth. The "ground truth" was determined by the presence or absence of bacterial growth in the broth.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. This was a laboratory test with objective endpoints (bacterial growth).

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. This was a non-clinical laboratory study of a valve, not a study involving human readers or AI.

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

Yes, in essence. The device (BACSTOP valve) was tested in a standalone manner, meaning its performance was evaluated independently without human intervention during the "backflow prevention" process itself. Humans set up the experiment and observed the results, but the valve's function was autonomous.

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

The ground truth for the backflow prevention tests was determined by laboratory culture for bacterial growth. The absence of bacterial growth in the broth after exposure to the challenge suspension indicated effective backflow prevention.

8. The sample size for the training set

Not applicable. This device (a physical valve) does not involve a "training set" in the context of machine learning or AI algorithms. The "training" for its design and manufacturing would be engineering and material science principles, not data-driven learning.

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

Not applicable. As above, there is no "training set" for a physical device in this context.

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