(185 days)
The Dental Handpiece is used by authorized persons in the practice of dentistry.
This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.
High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's sharik (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.
This document is a 510(k) summary for the Henry Schein/HHC/SCORE Canister Handpiece, indicating a premarket notification for a dental device. The primary finding is that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating equivalence rather than conducting new clinical studies with established acceptance criteria and detailed performance reporting.
Therefore, the information typically found in a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) is not present in this document.
Here's an analysis based on the provided text, highlighting the absence of the requested clinical study data:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided.
The document states: "The canister handpiece is as safe and effective as the predicate device as cited above." This is a statement of substantial equivalence, not a report of specific performance metrics against pre-defined acceptance criteria from a clinical study. No specific quantitative or qualitative acceptance criteria are listed, and no detailed performance data (e.g., accuracy, precision, durability, success rates) are reported.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided.
Since no new clinical study demonstrating performance against acceptance criteria was conducted or reported, there is no test set sample size or data provenance information. The basis for equivalence is a comparison of design and functional principles with existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided.
No test set requiring expert ground truth establishment is mentioned.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
No test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not provided.
No MRMC study was conducted or reported. The document focuses on device design and intended use equivalence, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable/Not provided.
This device is a mechanical dental handpiece, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is irrelevant.
7. Type of Ground Truth Used
Not applicable/Not provided.
There is no "ground truth" mentioned in the context of a clinical performance study. The ground truth for this submission is the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set
Not applicable/Not provided.
No training set is mentioned as this is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
As there is no training set for an algorithm, this question is not relevant.
Summary of Device Rationale from the Document:
The basis for market clearance for the Henry Schein Canister Handpiece is substantial equivalence to an already legally marketed predicate device (SUPER-AIR S & SUPER-AIR U Handpiece Models manufactured by PENG LIM ENTERPRISE CO., Ltd.).
The document describes the device and its intended use, then states: "The canister handpiece is as safe and effective as the predicate device as cited above." This implies that by being similar in design, function, and intended use to a device already deemed safe and effective, no new, extensive clinical studies demonstrating specific performance against novel acceptance criteria were required for this 510(k) submission.
The "study" in this context is the comparison against the predicate device, not a clinical trial.
§ 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.