(12 days)
The DentaPure® DP40 Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.
The DentaPure® DP40 Cartridge is an in-line assembly incorporating iodinated resin and a polyolefin filter. The cartridge is connected to the pickup tube of a bottle water system. It consists of a polyolefin in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units with independent bottle water systems. The cartridge is installed in the bottle reservoir tubing with quick connect fittings for ease of change.
The provided document is a 510(k) summary for the DentaPure® DP40 Cartridge, a dental unit waterline purification cartridge, and a letter from the FDA regarding its substantial equivalence. It does not contain a study with detailed acceptance criteria and reported device performance in the format requested. The document describes the device's intended use and general performance claims but lacks the specific data points often found in a scientific study report.
However, based on the information provided, I can infer some elements as they relate to the device's performance claims.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reduce bacteria levels in dental unit water lines to less than 200 cfu/ml (ADA recommendation). | Commonly reduce bacteria levels to less than 100 cfu/ml. |
Missing Information Based on Request:
The document is a premarket notification for a medical device and describes its intended use and general performance claims. It is not a detailed study report, therefore much of the requested information about a specific study's methodology, sample sizes, expert involvement, and ground truth establishment is not present.
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 device is not an AI-assisted diagnostic tool; it's a water purification cartridge.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claim relies on microbial colony-forming unit (cfu/ml) counts, which is an objective laboratory measure of bacterial concentration in water samples.
- The sample size for the training set: Not applicable. This device is not an AI/machine learning model that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance Claims from the Document:
The DentaPure® DP40 Cartridge is designed to be connected to the pickup tube of a bottle water system in dental operatories. It incorporates an iodinated resin and a polyolefin filter. As water flows through, the resin imparts 2-6 ppm of iodine, which is stated to reduce biofilm and the chance of cross-contamination by acting as a germicide. The filter portion retains water-borne particulate.
The key performance claim states: "When used in conjunction with these normal practices, the DentaPure® DP40 Cartridges commonly reduce bacteria levels to less than 100 cfu/ml." This performance is presented as exceeding the current ADA recommendation of having less than 200 cfu/ml in dental unit water lines.
The document is a regulatory submission demonstrating substantial equivalence to a predicate device (DentaPure® DP1, K963548), not a detailed scientific report on a specific study. Therefore, it focuses on asserting that the device meets safety and efficacy claims rather than providing extensive experimental data in the format of a clinical trial.
§ 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.