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510(k) Data Aggregation
(162 days)
The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.
Both the predicate and the new proposed devices are operated by connecting to a standard turbine connection of a dental unit, which supplies air and water. The device is activated when the dental unit is activated and compressed air and water are supplied to the device. Air enters into the powder chamber where it is mixed with the prophylaxis powder. The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.
Acceptance Criteria and Device Performance for QUICK JET M (K133170)
This document describes the acceptance criteria and supporting study for the QUICK JET M dental handpiece, as detailed in the 510(k) summary K133170.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for QUICK JET M (K133170) does not explicitly define quantitative acceptance criteria or specific performance metrics for the device. Instead, the submission relies on a comparison to a predicate device, the AIR-FLOW handy 2 (K022119), through the demonstration of substantial equivalence.
The "Comparison result" table in the submission highlights similarities between the proposed device and the predicate device across various technological characteristics. This indicates that the "acceptance criteria" were implicitly met by demonstrating that the QUICK JET M performs equivalently to the legally marketed predicate device, especially for its intended use.
Here's an interpretation of the implied acceptance criteria and the device's reported performance based on the provided document:
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Intended Use: Device effectively removes dental plaque, stain, and discoloration from tooth surfaces. | "Similar" to predicate device. The device's description states it "removes dental plaque, stain and discoloration from tooth surface." |
| Indication for Use: Treatment by dental professionals. | "Identical" to predicate device. |
| Target Population: Patients requiring dental plaque, stain, and discoloration removal. | "Identical" to predicate device. |
| Anatomical Safety: Safe for use in the oral cavity. | "Identical" to predicate device. |
| Energy Used/Delivered: Employs compressed air and water for powder delivery. | "Identical" to predicate device. Device operates by connecting to a standard turbine connection of a dental unit, supplying air and water. |
| Human Factors: Ergonomically suitable for dental professional use. | "Identical" to predicate device. |
| Design: Overall functional design. | "Similar" to predicate device. Both are operated by connecting to a standard turbine connection and mix air, water, and prophylaxis powder. |
| Performance: Effectively cleans tooth surfaces. | "Similar" to predicate device. Implied by similar intended use and design. |
| Material Biocompatibility: Materials used are biocompatible for oral contact. | "Unknown" due to lack of specific testing, but similarity to predicate suggests no new biocompatibility issues. |
| Compatibility with Environment & Other Devices: Compatible with standard dental unit connections. | "Identical" to predicate device. Connects to standard turbine connection. |
| Sterility: Able to be sterilized or single-use. | "Similar" to predicate device; implies capable of meeting sterility requirements. |
| Mechanical Safety: Safe mechanical operation. | "Identical" to predicate device. |
| Chemical Safety: Safe use of prophylaxis powder and mixture. | "Similar" to predicate device; implies safe handling of relevant chemicals. |
| Compliance with Applicable Standards: Meets relevant international standards. | "The proposed device was designed and tested according to the applicable international standards and specifications developed by the manufacturer." (Specific standards not listed). |
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary explicitly states: "No clinical tests were performed for the proposed device." Therefore, there was no "test set" in the context of clinical data used to prove device performance. The assessment of substantial equivalence was based on non-clinical testing and comparison of technological characteristics to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
As no clinical testing was performed and no test set was used, there were no experts involved in establishing ground truth for a clinical test set.
4. Adjudication Method for the Test Set
Since no clinical test set was used, there was no adjudication method employed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The 510(k) summary clearly states that no clinical tests were performed, which would include MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a dental handpiece, a mechanical tool, not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable to this device.
7. The Type of Ground Truth Used
As no clinical tests were performed, no clinical ground truth (e.g., expert consensus, pathology, outcomes data) was established or used for the QUICK JET M in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety profile of the predicate device, AIR-FLOW handy 2 (K022119), as assessed through non-clinical comparisons of technological characteristics.
8. The Sample Size for the Training Set
The device is a mechanical dental handpiece, not a machine learning or AI algorithm. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable to this device, there was no ground truth established for a training set.
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