(30 days)
The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used. - . Grinding and trimming on dentures and bridge work. - Polishing and finishing of natural dentition . - Endodontio abcess procedures . - Cavity preparation. t - Crown and cap preparation . - Post and pin setting . - Implant setting .
The Master line of air driven handpieces are intended for use in a variety of non-surgical dental laboratory and operatory applications. They are typically coupled with a selection of attachments and angle heads to provide the licensed practitioner with the correct range of torque and speed to perform the desired procedure.
This 510(k) submission document pertains to a Class I medical device, the "Master line of air driven handpieces" for dental applications. Class I devices are subject to general controls and typically do not require extensive clinical studies or robust acceptance criteria demonstrations like those needed for higher-risk devices. Therefore, the information you've requested regarding detailed acceptance criteria and a study proving performance against them is not present in this type of submission for a Class I device.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate.
Here's an analysis based on the provided document, addressing your questions where applicable and explaining why certain information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. For Class I devices like dental handpieces, the "acceptance criteria" are generally tied to demonstrating equivalence in functionality, materials, and sterilization to existing predicate devices, rather than specific quantitative performance metrics tested against pre-defined thresholds. The submission asserts that the device utilizes "materials commonly known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization," which implies meeting common industry standards for device durability and reusability, but no specific performance data or acceptance targets are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As explained above, for Class I devices seeking 510(k) clearance through substantial equivalence, a formal "test set" in the context of a robust performance study (like for AI/diagnostic devices) is generally not required or performed for a device like a dental handpiece. The evaluation is often based on engineering specifications, material properties, and comparison to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. There is no "ground truth" establishment as would be required for a diagnostic device or an AI algorithm. The device's function is mechanical, and its intended uses are well-established dental procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no "test set" and no "adjudication" in the context of expert review for this type of 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
This information is not applicable/not provided. This device is a mechanical dental handpiece, not an AI or diagnostic tool. Therefore, an MRMC study is entirely irrelevant to its submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. As a mechanical device for dental procedures, the concept of "ground truth" as used in diagnostic or AI device evaluations does not apply. The device's effectiveness relies on its ability to perform its mechanical functions (e.g., rotation, torque, speed) reliably and safely, analogous to the predicate device.
8. The sample size for the training set
This information is not applicable/not provided. There is no AI component or "training set" for a mechanical dental handpiece.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no AI component or "training set," there's no ground truth to establish for it.
Summary of what the document does provide:
- Predicate Devices: The document clearly identifies the predicate device as "Lynx Classic 5K / Classic Air Motor," "Lynx TM5 - 5K," and "Lynx TM20 - 20K" (K940261).
- Intended Use & Indications for Use: The document clearly states the intended use for "dental laboratory and operatory non-surgical procedures by licensed practitioners" and provides examples like grinding, polishing, cavity preparation, etc.
- Device Description: It describes the device as "air driven handpieces" coupled with attachments for various dental procedures, emphasizing the use of materials "commonly known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization."
- Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate substantial equivalence to the predicate devices, thereby ensuring the new device is as safe and effective as devices already on the market. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
In conclusion, for a Class I mechanical device like a dental handpiece, the regulatory pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies with detailed acceptance criteria and ground truth establishment typically found for novel, higher-risk, or AI-driven devices.
§ 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.