(97 days)
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.
The PACEMAKER High-Speed Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece. This impels the turbine in the head of the handpiece to revolve. Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a pushbutton.
There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device.
Similar to the predicate device, the PACEMAKER High-Speed Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the PACEMAKER High-Speed Handpiece:
The provided 510(k) summary does not include detailed acceptance criteria or a study proving the device meets them in the quantifiable terms typically associated with AI/medical device performance evaluation. This submission is for a dental handpiece, a mechanical device, and the regulatory approach for such devices differs significantly from that for AI-driven software or diagnostic tools.
Instead of clinical performance metrics like sensitivity, specificity, or reader improvement, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards.
Here's a breakdown based on your requested information, acknowledging the limitations given the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Conformance to ISO 7785-1:1997 | Performed testing against this standard. (Implies conformance was achieved for substantial equivalence claim) |
| Conformance to ISO 9168:1991 | Performed testing against this standard. (Implies conformance was achieved for substantial equivalence claim) |
| Materials are biocompatible | Materials used are "well-known biocompatible." |
| Safe and effective for intended use | Concluded to be "both safe and effective for its intended use" based on non-clinical tests and comparison to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. For mechanical device testing against ISO standards, the "sample size" would typically refer to the number of units tested. This information is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical, likely performed in a controlled laboratory environment to assess mechanical properties and safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there is no "ground truth" in the clinical sense for this type of mechanical device submission described. The evaluation relies on standardized non-clinical tests.
4. Adjudication Method for the Test Set
- Not applicable as there is no human interpretation or subjective assessment of a diagnostic output that would require adjudication. The testing involved objective measurements against established ISO standards.
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
- No, an MRMC study was not done. This device is a mechanical dental handpiece, not an AI-driven diagnostic or assistive tool. Therefore, the concept of "human readers" or "AI assistance" does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance evaluation (in the context of an algorithm) was not done. This is a mechanical device, not an algorithm. Its "standalone" performance refers to its ability to meet engineering specifications and safety standards as tested in the lab.
7. The Type of Ground Truth Used
- The "ground truth" for this device is conformance to established international engineering and safety standards (ISO 7785-1:1997 and ISO 9168:1991), alongside comparison to the known performance and safety profiles of legally marketed predicate devices. There is no pathology, expert consensus (in the diagnostic sense), or outcomes data used for "ground truth" here.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As noted above, there is no training set for this type of device.
Summary of the Study:
The "study" conducted for the PACEMAKER High-Speed Handpiece was a non-clinical performance evaluation against two internationally recognized ISO standards:
- ISO 7785-1:1997: Specifies requirements for dental handpieces.
- ISO 9168:1991: Specifies methods for the determination of noise emitted by dental handpieces.
The purpose of these tests was to demonstrate that the device's design and performance are comparable to the predicate devices and meet established safety and performance benchmarks for dental handpieces. The submission concludes that, based on these non-clinical tests and the comparison to predicate devices, the PACEMAKER High-Speed Handpiece is "both safe and effective for its intended use" and "substantially equivalent" to its predicates. No clinical trials were performed.
§ 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.