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510(k) Data Aggregation
(84 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Prevention of bacterial backflow for 5 consecutive days of use, with 1 liter of water passing through daily in 250 three-second pulses. | Average fluid withdrawn into waterline: 0.05 microliters, representing a 99.975% reduction in contamination compared to a control without functioning check valves. |
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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(106 days)
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction check valve for use in dental unit water lines. It is intended to be used, in line, as a means of controlling bacteriological contaminants in the dental water and preventing the retraction of orally contaminated fluids into the dental line. It is to be used for all patients and changed every week, or 5 working days.
Clearline Plus is a disposable microfiltration cartridge with approximately 10 sq. cms. of polyethersulfone membrane with 0.2 micron pores and a normally closed check valve at the exit port. The check valve has a silastic rubber membrane which operates with a cracking pressure of 1.5 psi.
This document describes the performance testing for the CLEARLINE® PLUS dental waterline filter, which combines a microfiltration cartridge and an anti-retraction check valve.
1. Acceptance Criteria and Reported Device Performance:
The device has two primary functions: bacterial retention and backflow prevention.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Retention: To provide filter sterilized water and prevent bacterial contaminants in the dental water system from entering the water flow downstream of the device for a period of five working days, when subjected to a typical on/off use pattern. (Equivalent to predicate device claim of "commonly reduce bacterial levels to less than one cfu/milliliter" downstream of the filter.) | In two modes of pulsatile flow (20-second pulses for 50 cycles/day, and 3-second pulses for 250 cycles/day), no Serratia contamination of the filtrate was detected after passing more than 8 liters of a ~100,000 cfu/mL challenge bacterial suspension and over 1,000,000,000 cfu of bacteria over the 5-day test period. This demonstrates effective bacterial retention for at least 5 working days. |
| Backflow Prevention (Anti-Retraction): To prevent backflow (or "suckback") of patient-derived microorganisms into a dental line, even when there is negative pressure applied upstream, over a five-day working period. (Equivalent to predicate device claim of "reduces the chance of cross-contamination by introducing the germicide iodine into the water system, downstream of the filter.") | After 1250 on/off cycles over 5 consecutive 8-hour sessions (mimicking a heavy use pattern for a working week), three of six tested check valves showed zero bacteria on culturing the downstream tube contents after a Chromobacterium backflow test. The other three showed an average of 0.11 microliters of suspension drawn into the tubing. Since approximately 45 microliters of retraction is allowed before material reaches the dental waterline upstream of the coupler according to A.D.A./A.N.S.I. specification #47, this level of backflow control is deemed compatible with preventing contamination of the dental water line for 5 working days. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bacterial Retention Test: 6 Clearline® Plus cartridges were tested in the first mode (20-second pulses) and an unspecified number (but implies 6 based on overall context) in the second mode (3-second pulses). The entire study appears to use 12 devices in total, suggesting 6 per mode.
- Backflow Prevention Test: 6 Clearline® Plus devices (with integrated BacStop™ valves) were tested.
- Data Provenance: The study was conducted retrospectively as part of a 510(k) submission, implied to be conducted by the submitter (SciTech Dental, Inc.) in a laboratory setting. There is no mention of country of origin for the data itself, but the submitter is based in Seattle, WA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This study involves performance testing against quantifiable metrics (bacterial count, liquid volume) rather than subjective expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. Ground truth was established by direct measurement and culturing, not expert adjudication.
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:
Not applicable. This is a performance study for a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm. The device's performance was assessed directly.
7. The Type of Ground Truth Used:
- Bacterial Retention: Absence of cultivable Serratia contamination in filtrate. This is based on laboratory culturing of samples.
- Backflow Prevention: Absence of cultivable Chromobacterium violaceum (marker bacterium) in the downstream tubing, and measured volume of backflow. This is based on laboratory culturing and volumetric measurement.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm; 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 this type of device.
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(89 days)
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.
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.
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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