(139 days)
The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. The filter incorporating fournated roshe connection to the handpiece. This is illustrated in Figure 1.
The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. It consists of A schematic of the cartings is vith the outer chamber filled with a lichiorane type in mage resin that imparts 2-4 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to be bacterially retentive, and would thereby reduce the amount of bacteria that would reach the patient from the dental water system. The iodine that is released reduces 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. The filter is installed in each dynamic instrument water tubing with quick connect fittings for ease of changing on a weekly basis.
The provided text describes the DentaPure™ Cartridge, an inline water filter for dental operative units. The key performance criteria here revolve around the reduction of bacteria in dental unit water lines.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ADA Recommendation) | Reported Device Performance (DentaPure™ Cartridge) |
|---|---|
| Less than 200 cfu/ml | Less than 1 cfu/ml (commonly reduces) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Test 1 (Iodine Residual): Specific sample size not mentioned, but it refers to "samples of the first 5 ml" taken over "43 days."
- Test 2 (Dental Office Conditions): Specific sample size not mentioned, but it refers to "Tests" performed in "a dental office."
- Data Provenance:
- Test 1: Performed internally (likely by the manufacturer or a laboratory contracted by them) to show "efficacy of the DentaPure™ Cartridge and its substantial equivalence to the Clearline™ filter."
- Test 2: "performed in a dental office, under actual conditions." This suggests prospective, real-world data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications for establishing the ground truth. The "ground truth" here is the bacterial count, which is likely determined by standard microbiological laboratory methods by technicians. There's no mention of clinical expert judgment involved in establishing the bacterial count.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method. Bacterial counts are typically objective measurements, not subject to adjudication in the same way as, for example, image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a filter, not a diagnostic aid requiring human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance described is standalone. The device (filter) itself is being tested to reduce bacterial counts; there is no "human-in-the-loop" interaction with the device in terms of its core function, only in its installation and regular maintenance.
7. Type of Ground Truth Used:
- Bacteriological counts (Colony Forming Units - cfu/ml): This is a direct, objective measurement of the presence and quantity of viable bacteria.
8. Sample Size for the Training Set:
- The document does not mention a "training set" in the context of device development or performance. This is a physical device, and its efficacy is tested rather than "trained" like a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for this physical 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.