(86 days)
To isolate water delivery lines in the dental operatory unit and reduce the contamination due to To isolate watch delivery mics in the dental operation, to dental handpieces and other dental instruments.
Accessory to dental unit, dental line-cleaner, Water-Delivery Device
The provided text describes a 510(k) premarket notification for a dental water-delivery device called Hygeniclear™ WKR 1 (also known as Ultraclear™).
However, the document is a regulatory submission for substantial equivalence and does not contain acceptance criteria, specific device performance data, or details of a study proving the device meets acceptance criteria.
The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance studies like those often seen for novel, higher-risk devices.
Therefore, most of the information requested in your prompt cannot be extracted from this document. I will fill in what can be gathered and explain why other sections are not present.
Summary of Acceptance Criteria and Study Information (Based on the provided document):
This document is a 510(k) submission for demonstrating substantial equivalence to predicate devices. It does not contain pre-defined acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a clinical trial would. Instead, the "acceptance criteria" are implied by the FDA's "substantial equivalence" decision, meaning the device's technological characteristics and intended use are similar enough to existing, legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) Path) | Reported Device Performance (as per document) |
|---|---|
| Intended Use: |
- Provide cleaner water supply for dental operative units.
- Assist in lubricating dental instruments.
- Isolate water delivery lines and reduce contamination to handpieces and other dental instruments. | "Has the same intended use, to provide a cleaner water supply for use with dental operative units and to assist in lubricating dental instruments."
"To isolate water delivery lines in the dental operatory unit and reduce the contamination due to to dental handpieces and other dental instruments." |
| Technological Characteristics: - Similar to predicate devices.
- Technological features vary but have same intended use of keeping waterlines free of contaminants. | "The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for differences in methods of use."
"The technological features vary but the devices have the same intended use of keeping waterlines free of contaminants." |
| Materials: - Substantially equivalent to similar products. | "Descriptive information provided shows that the materials from which the delivery unit of Hygeniclear™ WKR 1 is made are substantially equivalent to those of similar products, used for identical purposes, currently on the market." |
| Patient Contact: - No patient contact.
- Operating instructions for proper use, including acceptable disinfectants. | "This product does not contact patients. Operating instructions clearly indicate proper use of the device, either with or without disinfectant/lubricant added to the water. The instructions prescribe acceptable disinfectants which have been cleared by the FDA through the 510(k) process." |
| Safety and Effectiveness: - Demonstrated through substantial equivalence to predicate devices. | The FDA deemed the device substantially equivalent, implying it is as safe and effective as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a test set or associated data for direct performance evaluation in the way a clinical study would. The submission relies on a comparison to predicate devices. The submitter is based in Canada (Markham, Ontario) and the FDA in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or adjudication method is described.
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 / Not provided. This device is a physical dental accessory, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. The "ground truth" in a 510(k) is essentially the established safety and effectiveness of the predicate devices to which the new device is compared. This is a regulatory assessment, not a scientific "ground truth" derived from patient data.
8. The sample size for the training set:
- Not applicable / Not provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No training set is mentioned.
§ 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.