(446 days)
This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry.
The Highspeed Airturbine Handpiece is air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the pre-vacuum Autoclave methods. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's performance in the typical sense of a diagnostic or predictive algorithm. Instead, it focuses on compliance with established international standards for dental devices and comparison to predicate devices, demonstrating substantial equivalence. The "performance" section for the proposed device cites compliance with these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-5:2009 (Cytotoxicity) | Biocompatibility demonstrated (via K172543) |
| ISO 10993-10:2010 (Irritation & Sensitization) | Demonstrated by K172543 (No Intracutaneous Reactivity, No Skin Sensitization) |
| ISO 9168:2009 (Hose Connectors) | Compliance with ISO 9168:2009 |
| ISO 14457:2012 (Handpieces & Motors) | Compliance with ISO 14457:2012 |
| ASTM D4169:2016 (Shipping Containers) | Complies with standard |
| FDA Reprocessing Guidance Document (Cleaning & Sterilization) | Cleaning and Sterilization Validation per guidance |
| Light Intensity (Requirement of ISO 14457) | Meets requirement of ISO 14457 (though different from predicate) |
| Speed in RPMs (Performance Test per ISO 14457) | Test results meet acceptable criteria for ISO 14457 |
| Bur Retention Force (from Comparison Table) | 22 |
| Sterilization (per ISO 17665) | Sterilization parameters comply with ISO 17665 standard |
2. Sample size used for the test set and the data provenance
Not applicable. This is a submission for a physical medical device (dental handpiece), not a software or AI device that typically uses test sets or data. The "tests" mentioned are non-clinical studies evaluating physical and biological properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device submission. Ground truth, in the context of expert consensus, is not a relevant concept here.
4. Adjudication method for the test set
Not applicable. This is a physical device submission.
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 physical device submission, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this physical device, "ground truth" would be the objective measurements and adherence to specified performance standards as evaluated in non-clinical laboratory settings.
8. The sample size for the training set
Not applicable. This is a physical device submission; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria is a series of non-clinical tests conducted to demonstrate the proposed Highspeed Airturbine Handpiece's compliance with established international standards and its substantial equivalence to legally marketed predicate devices.
- Non-Clinical Test Conclusion (Section 6): The submission states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
- Standards Complied With: The tests demonstrated compliance with:
- ISO 10993-5:2009 (Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10:2010 (Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
- ISO 9168:2009 (Dentistry - Hose Connectors For Air Driven Dental Handpieces)
- ISO 14457:2012 (Dentistry - Handpieces And Motors)
- ASTM D4169:2016 (Standard Practice For Performance Testing Of Shipping Containers And Systems)
- FDA Reprocessing Guidance Document (Cleaning and Sterilization Validation)
- Biocompatibility: For biocompatibility, the proposed device's patient-contact materials (brass and aluminum) were considered identical to those in reference device K172543. The document states that "The biocompatibility testing for K172543 was evaluated and the tests results complied with ISO 10993 standards." This essentially leverages prior testing on a similar, already cleared device from the same manufacturer.
- Performance (Speed in RPMs): "the performance test has been conducted on proposed device according to ISO 14457 and the test results meet the acceptable criteria."
- Sterilization: The sterilization parameters tested "comply with ISO 17665 standard."
Overall: The acceptance criteria are essentially defined by compliance with recognized international and national standards for dental handpieces, and "performance" is demonstrated through non-clinical testing against these standards, often referencing predicate devices for establishing substantial equivalence. No clinical studies were included in this submission (Section 7).
§ 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.