(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.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.