(127 days)
The DENTAPORT ZX is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
The DENTAPORT ZX is a low-voltage electric motor and root canal length measuring device.
This 510(k) submission (K031204) for the DENTAPORT ZX Dental Device is a Special 510(k) and focuses solely on a change in sterilization instructions. Therefore, it does not include a study demonstrating the device's performance against acceptance criteria. The submission states directly: "The DENTAPORT ZX covered by this submission is identical in every respect to the DENTAPORT device already authorized by the FDA under K#022147. The only difference is a change in the instructions for use regarding the sterilization of the device."
The approval is based on the substantial equivalence to the predicate device (K#022147) and the validation of the new sterilization parameters.
As such, most of the requested information regarding performance studies is not applicable to this specific 510(k) submission.
Here's a breakdown of what can and cannot be provided from the given document:
1. Table of acceptance criteria and reported device performance:
- Not applicable for this 510(k). This submission is for a change in sterilization procedures, not a de novo device or a significant performance modification requiring new clinical or bench performance data for the primary function of root canal measurement. The performance of the device's primary function is assumed to be equivalent to the predicate (K#022147).
2. Sample size used for the test set and data provenance:
- Not applicable for primary device performance. The only "test" mentioned relates to sterilization validation, not the accuracy of root canal length measurement. For sterilization studies, sample sizes would typically relate to the number of sterilization cycles and biological indicators/test articles, but this information is not detailed in the provided summary.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. No clinical or performance test set, in the context of root canal measurement accuracy, is described in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical or performance test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable. This device is a measurement and treatment device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware and does not describe an algorithm for standalone performance. Its function relies on human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for root canal measurement accuracy. For sterilization validation, the "ground truth" would be the successful killing of microorganisms to achieve a sterility assurance level (SAL) of 10^-6, verified typically by biological indicator testing, but this is not detailed here beyond the statement that it was validated.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
In summary, this 510(k) submission (K031204) is a limited submission for a change in sterilization instructions for an already cleared device, not a submission introducing new performance claims or requiring new clinical efficacy data for its primary function. The "study" referenced would be the validation of the new sterilization parameters to achieve an appropriate sterility assurance level, which is mentioned as successfully completed ("The new sterilization parameters have been properly validated and result in a sterility assurance level of at least 10^-6"). Specific details of that sterilization validation study (e.g., sample size of test articles/cycles) are not provided in this public summary.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.