(8 days)
The INTEGRITY Air Powered Low Speed Handpieces are intended for removing curious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.
The Integrity Low Speed Handpiece is a 5-vane motor, ranging in speed up to 20,000 RPM, and is compatible to all standard 2, 3 or 4 hole fixed air connection. It accepts all brands of ISO E-Type or U-Type attachments. The Motors and Straight Nose Cone are used for general dentistry procedures.
The provided text is a 510(k) summary for the OSSEO SCIENTIFIC, LLC INTEGRITY LOW SPEED HANDPIECE & ATTACHMENT. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is largely not applicable in the context of this 510(k) submission as it is not a clinical performance study. The device is cleared based on its similarity to already approved devices.
Here's an breakdown based on the provided text:
Acceptance Criteria and Device Performance
As this is a 510(k) submission primarily relying on substantial equivalence, explicit "acceptance criteria" presented as measurable performance targets are not defined in the way they would be for a novel device undergoing extensive clinical trials. Instead, the "acceptance criteria" can be inferred as the characteristics and performance of the predicate devices. The device meets "acceptance criteria" by demonstrating that its design, materials, and performance are identical or similar to those predicates.
| Parameter | Acceptance Criteria (Inferred from Predicate Devices) | Reported Device Performance (INTEGRITY Handpiece) |
|---|---|---|
| Intended Use | Identical to predicate devices | Identical |
| Indications for Use | Identical to predicate devices | Identical |
| Target Population | Identical to predicate devices | Identical |
| Anatomical Sites | Identical to predicate devices | Identical |
| Where Used | Identical to predicate devices | Identical |
| Energy Used/Delivered | Identical to predicate devices | Identical |
| Human Factors | Identical to predicate devices | Identical |
| Design | Similar to predicate devices | Similar |
| Performance | Identical to predicate devices (e.g., speed results) | Identical (e.g., similar speed results reported) |
| Standards Met | Conformance to applicable ISO standards (7785-2, 1797, 9168, 3964) | Identical (conforms to specified ISO standards) |
| Materials | Identical specification to predicate devices | Identical |
| Biocompatibility | Not explicitly detailed but implied to be acceptable based on predicate. | Not explicitly detailed but implied to be acceptable based on predicate. |
| Compatibility with Environment and Other Devices | Identical to predicate devices | Identical |
| Sterility | Ability to be repeatedly and adequately sterilized | Being confirmed by validation protocol; will be available for inspection. |
| Mechanical Safety | Implied to be acceptable based on predicate and ISO standards. | Implied to be acceptable based on predicate and ISO standards. |
| Electrical Safety | Implied to be acceptable based on predicate. | Implied to be acceptable based on predicate. |
| Chemical Safety | Implied to be acceptable based on predicate. | Implied to be acceptable based on predicate. |
| Thermal Safety | Implied to be acceptable based on predicate. | Implied to be acceptable based on predicate. |
| Radiation Safety | Not applicable for this device type. | Not applicable for this device type. |
Study Information (Not Applicable for this 510(k) Type)
- Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence and comparison to predicate devices, not an independent test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This submission relies on substantial equivalence and comparison to predicate devices.
- Adjudication method for the test set: Not applicable.
- 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 dental handpiece, not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental handpiece, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a "ground truth" for a performance study. The "truth" in this submission is established by the safety and effectiveness of the legally marketed predicate devices.
- The sample size for the training set: Not applicable. This is a hardware device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Substantial Equivalence:
The Osseo Scientific, LLC INTEGRITY Low Speed Handpiece & Attachment aims to demonstrate substantial equivalence to several predicate devices, including:
- For Model INT-E: A-dec/W&H Synea & TreND Low Speed (K944713 & K993526) and Dabi Atlante Low Speed (K926154).
- For Model INT-SNC: A-dec/W&H Synea & TreND (K993526), Dabi Atlante (K926155) and MK-dent Straight Handpiece (K051872).
- For Model INT-D: Promident Low Speed (K781545).
The submission states that the INTEGRITY handpieces share "virtually all specifications and design characteristics" with the predicate devices. Key performance aspects like air connection, interface with other dental attachments, air pressure, and speed results were found to be "identical" or "similar." The handpieces are constructed of materials of "identical specification" to the predicate devices and conform to applicable ISO standards (7785-2, 1797, 9168, 3964). The ability to sterilize the device was undergoing validation at the time of the submission.
The conclusion is that, based on this comparison, the INTEGRITY Air Powered Low Speed Handpieces are substantially equivalent to the claimed predicate devices, meaning they are considered as safe and effective as the predicates already on the market.
§ 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.