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510(k) Data Aggregation
(71 days)
DR DISPOSABLE PROPHY ANGLE MODEL H310
The DR Disposable Prophy Angle is a device intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.
The DR Disposable Prophy Angle is a dental device that consists of a pair of gears, a turning spindle and a drive spindle enclosed in a plastic housing, that connects to a low speed dental handpiece. The turning spindle has a prophylaxis cup attached to the end which holds dental tooth polishing paste.
Here's an analysis of the provided text regarding the DR Disposable Prophy Angle, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for the DR Disposable Prophy Angle. Instead, it relies heavily on demonstrating substantial equivalence to a predicate device (Oral-B Disposable Prophy Angle W/Prophy Cup, K932990) by comparing various characteristics.
The "acceptance criteria" can be inferred as matching or being equivalent to the predicate device in the following categories:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (DR Disposable Prophy Angle) | Predicate Device Performance (Oral-B Disposable Prophy Angle) | Notes |
|---|---|---|---|
| Usage | Single use by dental professionals to clean patient's teeth; disposed of after use on one patient. | Same | |
| Target Users | Professional Dentists and Hygienists. | Same | |
| Location of Use | Dental Offices. | Same | |
| Product Design | Plastic one-piece housing with 1 internal drive shaft and a spindle aligned at a right angle; tip fitted with rubber prophy cup. | Same | |
| Dimensions: Length | 49mm at insert | 49mm at insert | |
| Dimensions: Diameter | 12mm; 9mm at end | 12mm; 9mm at end | |
| Sterility | Non-Sterile | Non-Sterile | |
| Bio-compatibility | Prophy cups made of Non-Latex natural rubber. | Prophy cups made of natural rubber. | Minor difference: DR device uses "Non-Latex" natural rubber, which is usually considered an improvement for allergy concerns, not a deviation from equivalence. |
| Drive Mechanism | Rotation shafts driven by low speed dental hand piece. | Same | |
| Compatibility with Dental Handpiece | Designed to fit securely onto most ISO fitting standard slow speed dental hand pieces. | Same | |
| Performance | Sufficient for one cleaning cycle for one patient. | Same | |
| Mechanical Safety | Robust construction to withstand forces generated during cleaning cycle. | Same |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe an explicit test set or sample size for testing the DR Disposable Prophy Angle. The submission is a 510(k) Premarket Notification, which often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive new clinical trials or performance studies for low-risk devices like this.
There is no mention of "country of origin of the data" or whether data was "retrospective or prospective" because an independent study with a test set, in the traditional sense, was not the primary basis of this submission. The comparison is based on the characteristics of the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there was no explicit "test set" and "ground truth" derived from expert consensus described in the submission for performance evaluation. The "ground truth" for the predicate device's characteristics would have been established during its own regulatory review, or by industry standards and common knowledge for such a device.
4. Adjudication Method for the Test Set
This information is not applicable as no test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. This type of study is more common for diagnostic imaging AI devices, not for a mechanical dental instrument like a prophy angle.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a mechanical dental instrument and does not involve any algorithms or artificial intelligence.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for this 510(k) submission is the established performance and safety characteristics of the predicate device, based on its prior market clearance (K932990) and general industry understanding of dental prophy angles. The argument is that the new device shares the "same intended use, performance and safety characteristics" as the predicate.
8. The Sample Size for the Training Set
This question is not applicable as the device does not involve algorithms or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #8.
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