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510(k) Data Aggregation
(75 days)
PRO-FLEX DISPOSABLE PROPHY ANGLE
For one time use as part of a professionally administered prophylaxis treatment, to clean and polish teeth.
The device is a disposable dental prophylaxis angle which consists of a plastic body integrally formed with a drive mechanism, and a rubber cup that attaches to a retention knob or stud on the angle. The prophy angle has a slot for connecting the angle to a dental handpiece, which powers the prophy angle. The drive shaft of the prophy angle allows the rubber prophy cup to rotate.
The provided text describes a 510(k) premarket notification for a dental prophylaxis angle. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with explicit acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the given document.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device does not cause serious injury or death. | No serious injury or death events reported in MDRs from 1992-1996 for prophy angles. |
| Safety: Device malfunctions (stalling, locking, drive gears coming apart, heating, rubber cup coming off) do not result in injury. | Malfunctions (stalling, locking, drive gears coming apart, heating, rubber cup coming off) were reported, but no injuries were attributed to these malfunctions. |
| Effectiveness: Cleans and polishes teeth. | The submission asserts that the differences in design between the Pro-Flex™ and the predicate device "do not impact the safety and effectiveness of the device in any significant way since the function and intended use are the same." This implies an acceptance criteria that the device performs its intended function of cleaning and polishing teeth, similar to the predicate. No specific quantitative performance metrics (e.g., polishing efficiency, cleaning efficacy) are provided. |
| Substantial Equivalence: Technological characteristics are nearly identical or very minor differences that do not affect safety/effectiveness compared to the predicate device. | "The differences in design between the Pro-Flex™ and the predicate device are very minor and do not impact the safety and effectiveness of the device in any significant way since the function and intended use are the same." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of typical algorithm evaluation. The safety assessment relied on a retrospective review of existing Medical Device Records (MDRs).
- Sample Size: Over 200 MDRs filed with CDRH between 1992 and 1996 for prophy angles. This is not a direct test set for the Pro-Flex™ device itself, but rather a review of adverse events for similar devices.
- Data Provenance: The MDRs were "filed with CDRH" (Center for Devices and Radiological Health), implying a national/international scope as reported to the FDA in the USA. The data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The safety assessment involved a review of adverse event reports, not an expert panel establishing ground truth for a test set in a typical clinical study.
4. Adjudication Method for the Test Set
Not applicable. There was no explicit "adjudication method" for a test set. The review involved an analysis of reported incidents in MDRs.
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. This is a medical device (dental prophylaxis angle), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the safety assessment, the "ground truth" was based on reported adverse events and malfunctions documented in Medical Device Records (MDRs). For the effectiveness, the claim of "substantial equivalence" implies that the new device is functionally identical to the predicate device, which is presumably safe and effective based on its prior market clearance.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a physical medical device following a 510(k) pathway, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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