(124 days)
The SD500 High Speed Handpiece Series is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
The SD500 High-Speed Handpiece Series includes a fiber optic high speed handpiece, to be marketed as a SD500 Elite Handpiece and a non-fiber optic handpiece, to be marketed as a SD500 Pro Handpiece. Both the Elite and the Pro versions are available as lubefree or lubricated turbine handpieces. Each is a pneumatically driven handheld device with multiport water spray that is capable of reaching rotational speeds of 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. The series delivers a range of 39 - 50 watts of power providing .28 oz.-in. of stall torque at 43 psi. The handpieces are constructed of stainless steel, including the internal air and water tubes, which provide drive air to the turbine assembly and cooling water to the work site. The handpiece also uses PEEK in its construction. The handpieces incorporate either a lubefree ceramic bearing turbine assembly or a lubricated ceramic bearing turbine assembly. Both versions of the turbine assembly use a push button autochuck. The stainless steel and aluminum air driven turbine assembly provides rotation to the bur. The SD500 High-Speed Handpiece Series uses a quick disconnect coupler that allows easy connection to the dental line delivery tubing. This coupler allows for easy rotation of the handpieces when attached to the tubing. These couplers include both fiber optic and nonfiber optic versions with Type 3 or 2 connections. The fiber optic version uses LED technology to deliver the light to the handpiece. All couplers are autoclavable. The burs used with the SD500 High Speed Handpiece Series are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. A reader will enable the practitioner to track such things as usage and maintenance.
This document describes a 510(k) premarket notification for the SD500 High Speed Handpiece Series. It is a submission for a dental handpiece, which is a Class I reserved device. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and material characteristic comparisons and adherence to relevant industry standards, rather than clinical study results establishing diagnostic accuracy or comparative effectiveness with human readers.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, organized according to your request:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly state numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., "sensitivity > 90%"). Instead, the performance evaluation is based on meeting the requirements of recognized industry standards and demonstrating comparable performance to predicate devices. The "reported device performance" is largely described qualitatively or by reference to meeting these standards.
| Acceptance Criteria (Implied by Standards/Predicate Comparison) | Reported Device Performance (SD500 High Speed Handpiece Series) |
|---|---|
| Mechanical/Operational Performance Standards: | Complies with ISO 14457:2017 Dentistry Handpieces and Motors. |
| Electrical Safety Standards: | Complies with IEC 60601-1:2005 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance. |
| Sterilization Efficacy: | Sterilization validation performed in accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010). |
| Cleaning & Disinfection Efficacy: | Cleaning and disinfection validation conducted per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). |
| Biocompatibility: | Materials (Stainless steel, PEEK, Ceramic bearings) are "widely known and used within the dental and medical device industry." (No specific biocompatibility testing reported for the device, relying on established use of materials). |
| Risk Management: | Risk analysis developed using ISO14971:2012 Medical devices – Application of risk management to medical devices. |
| Rotational Speed: | Capable of reaching 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. (Comparable to predicate device 430 Torque which is 360,000 to 450,000 rpms at 38-43 PSI). |
| Power/Stall Torque: | Delivers a range of 39 - 50 watts of power providing 0.28 oz.-in. of stall torque at 43 psi. (Comparable to predicate device 430 Torque which delivers on average 20 watts of power providing 0.269 oz.-in. of stall torque). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench testing" and "test results" to demonstrate conformity with standards like ISO 14457 and IEC 60601-1.
- Sample Size: No specific numerical sample size is provided for these bench tests. This is typical for engineering performance testing of mechanical devices where testing is often done on a representative number of units to ensure consistency and compliance with specifications.
- Data Provenance: The tests were "conducted to evaluate the functional performance and safety." Given this is a 510(k) submission by DentalEZ Inc., located in Lancaster, Pennsylvania, USA, the testing was likely conducted in-house or by a contracted laboratory within the US or a region adhering to these international standards. The data is prospective as it was generated specifically for this submission.
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 product is a dental handpiece, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" and "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" does not apply in the context of this submission. The performance of the device is assessed against engineering specifications and industry standards, not against expert interpretations of diagnostic outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., expert review of medical images). Since this submission pertains to a mechanical device and its performance against engineering standards, no adjudication method as described would be applicable or necessary. Performance is measured objectively through physical tests.
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
No MRMC comparative effectiveness study was done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved in interpreting results, with or without AI assistance. The SD500 High Speed Handpiece Series is a direct therapy/procedural device, not a diagnostic or AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device does not involve any algorithms or AI for diagnostic or interpretive purposes. Its performance is entirely mechanical and physical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a mechanical device, the "ground truth" for its performance is established by:
- Compliance with Industry Standards: E.g., ISO 14457 (Dentistry Handpieces and Motors), IEC 60601-1 (Medical Electrical Equipment), ANSI/AAMI ST79, ISO 14937, ANSI/AAMI ST81 (for sterilization), FDA Guidance for "Reprocessing Medical Devices."
- Engineering Specifications: Meeting predefined rotational speed, power, and torque outputs.
- Material Compatibility: Use of materials with established safety profiles (Stainless steel, PEEK, Ceramic bearings) from existing industry knowledge.
These standards and specifications serve as the "ground truth" against which the device's physical and functional performance is measured.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it to be established.
§ 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.