(415 days)
The intended use of DPA is for polishing and cleaning teeth.
Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.
This FDA 510(k) clearance letter pertains to a Disposable Prophy Angle, a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, training set details) is not applicable to this document.
However, I can extract the relevant information regarding performance criteria and testing for this device.
Acceptance Criteria and Study for Disposable Prophy Angle (K240950)
This document describes the 510(k) clearance for a Disposable Prophy Angle, a dental handpiece accessory used for polishing and cleaning teeth. The device is not an AI/ML medical device, and thus, many of the typical AI/ML study parameters are not applicable.
The submission demonstrates substantial equivalence to predicate devices by meeting recognized performance requirements through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The documentation references compliance with a specific industry standard for performance.
| Acceptance Criterion (Standard Ref.) | Device Performance |
|---|---|
| Conformance to ANSI ADA Spec. No. 85, Part I: Disposable Prophy Angles, section 5.5 | The device "conforms to the performance requirements (nonclinical tests) as specified in ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5." This implies that all criteria within this section of the standard were met. |
| Temperature Rise (relative to predicate) | "Temperature rise...testing were performed on all models of the device (soft cup and firm cup) to demonstrate equivalent performance to the predicate device." (It passed, indicating equivalent or better performance against the predicate concerning temperature rise). |
| Vibration (relative to predicate) | "Vibration testing were performed on all models of the device (soft cup and firm cup) to demonstrate equivalent performance to the predicate device." (It passed, indicating equivalent or better performance against the predicate concerning vibration). |
Note: The specific numerical values or thresholds for "temperature rise" and "vibration" are not provided in this summary but would be detailed in the full test reports submitted to the FDA.
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This is a hardware dental device. The testing described is non-clinical performance testing (temperature rise, vibration) based on engineering specification compliance, not an AI/ML model evaluated on a test set of data. The "test set" would refer to the physical samples of the device and its components. The document doesn't specify the number of units tested, only that "all models of the device (soft cup and firm cup)" were tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). Ground truth based on expert review is specific to AI/ML or diagnostic image analysis. For this device, "ground truth" refers to established engineering standards (ANSI ADA Specification No. 85) and comparative performance against a predicate device.
4. Adjudication method for the test set
Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in AI/ML or diagnostic studies. This is a non-clinical, hardware performance test.
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
Not Applicable (N/A). This is not an AI/ML device; therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). This is not an algorithm or software device.
7. The type of ground truth used
The "ground truth" (or basis for acceptance) for this device's performance testing is:
- Established engineering standards: Specifically, "ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5."
- Comparative equivalence: Demonstration of "equivalent performance to the predicate device" for temperature rise and vibration.
8. The sample size for the training set
Not Applicable (N/A). This is a hardware device; there is no training set for an AI/ML model.
9. How the ground truth for the training set was established
Not Applicable (N/A). There is no training set for an AI/ML model.
§ 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.