(79 days)
The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist.
Our disposable prophylaxis angle is intended as a single use device used by a Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and should be discarded after each patient.
Plastic disposable item comprising a housing (body) that holds two plastic shafts aligned at 90 degrees (right angle) to each other that rotate a cup or brush.
Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth.
This document describes the St. George Technology, Inc. Perfection Plus Disposable Prophy Angles and their substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (St. George Technology Perfection Plus DPA) |
|---|---|---|
| Indications for Use | For single use by Dental Professional in cleaning patient's teeth. | Same (Intended as a single-use device during professional prophylaxis treatment of patient's teeth by a dentist or hygienist.) |
| Target Population | Dentists and Hygienists | Same |
| Design | Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth. | Same |
| Materials | Two types of plastic with either a rubber cup or brush fitted at the cleaning tip. | Same (Non-latex material used on all cups - Improvement over predicate) |
| Performance | To be able to perform a full cleaning procedure. | Satisfactorily performed when compared to the predicate device in all criteria (fit, wear, duration of performance, strength, and durability). |
| Sterility | Non Sterile | Same |
| Biocompatibility | Have caused concern with latex allergies due to cup material. | Non latex material used on all cups - Improvement |
| Mechanical Safety | Robust construction to withstand forces involved in a cleaning. | Same |
| Energy Used/Delivered | Rotation of the cleaning device cup/brush tip provided by a slow speed hand piece | Same |
| Compatibility with other devices | Designed to fit securely onto most available ISO fitting standard slow speed hand pieces | Same |
| Where Used | Dental Office/Operatory | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the way it would for AI/ML performance. Instead, the testing described appears to be for mechanical and functional evaluation of the device.
- Sample Size: Not explicitly stated. The document mentions "extensively tested in in-vitro environments."
- Data Provenance: The tests were conducted in "in-vitro environments," meaning in a laboratory setting, rather than on human subjects or with clinical data. The country of origin for the data is not specified beyond St. George Technology, Inc. being a US-based company. The data is retrospective in the sense that it evaluates the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study is a non-clinical performance evaluation of a medical device, not an AI/ML study requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable for this type of non-clinical device performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a non-clinical performance study of a physical medical device (disposable prophy angles), not an AI/ML system. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document pertains to a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this study is the observed performance characteristics of the predicate device and the St. George Technology device under defined in-vitro testing conditions. This includes measurements of fit, wear, duration of performance, strength, and durability. It is based on objective, quantifiable physical properties rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. This is a medical device performance study, not an AI/ML study that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no "training set" in the context of this device performance study.
§ 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.