(48 days)
ProAngle™ disposable prophy angle is a device intended to polish and clean the surface of teeth. It should be attached to a low speed handpiece for operation.
ProAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.
The provided text is a 510(k) summary for a dental device, the "ProAngle™ disposable prophy angle." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a diagnostic AI device would.
Therefore, many of the requested categories for a clinical study with acceptance criteria simply do not apply to this type of submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: The device must be demonstrated to be "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is the primary "acceptance criterion" for a 510(k) submission. | The document explicitly states: "ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc." The FDA's letter (K030603) confirms this finding: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (...) to legally marketed predicate devices..." |
Regarding specific performance, the document describes the device's function: "It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth." The intended use is "for polishing and cleaning teeth." No specific quantitative performance metrics (e.g., polishing efficiency, wear resistance, noise levels) are provided or required for this type of submission focused on substantial equivalence to a well-established device type. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the 510(k) summary. A 510(k) for a Class I device like this typically relies on a comparison to a predicate device and adherence to general controls, not on a new clinical study with a test set of patients or data. The "test set" in this context is the comparison between the new device's design/function and the predicate device's design/function.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. No "ground truth" establishment by experts in a clinical study context is described or required for this 510(k) submission focused on substantial equivalence of a general dental tool. The "ground truth" for the predicate device's safety and effectiveness would have been established historically through its prior marketing and use.
4. Adjudication Method for the Test Set
This information is not applicable. No adjudication method is described as there isn't a "test set" in the context of a clinical performance study.
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. This device is a manual dental tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effect sizes are entirely irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical dental tool, not an algorithm, so a standalone algorithm performance evaluation is not relevant.
7. The Type of Ground Truth Used
This information is not applicable in the context of a clinical "ground truth" from pathology or outcomes data. The "ground truth" for this 510(k) is the established safety, effectiveness, and intended use of the predicate device (Allpro, Inc., Disposable prophy angle) as determined by its prior marketing clearance. The new device is simply confirming it matches this established "ground truth."
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" for an algorithm or a clinical study mentioned in this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is also not mentioned.
§ 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.