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510(k) Data Aggregation
(89 days)
STARCARE HANDPIECE MAINTENANCE UNIT
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.
Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.
The StarCare Handpiece Maintenance Unit is a device used for the cleaning and lubrication of dental handpieces. The provided text is a 510(k) summary, which outlines the device's characteristics and its equivalence to predicate devices, rather than a study report detailing performance against acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the StarCare Handpiece Maintenance Unit is not directly available within this document.
However, based on the information provided, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (as stated or implied) |
|---|---|
| Cleaning (Purging Old Lubricant) | "used for the cleaning, i.e. purging of old lubricant" |
| Lubrication | "and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines" |
| Compatibility with handpiece types | Compatible with "high speed handpieces, electric micromotor attachments and handpiece turbines" |
| Independent operation of turbine cleaning | "handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function." |
| Detection of connected handpiece/attachment | "The unit detects if a high speed handpiece or electric micromotor attachment is connected and delivers cleaner and lubricant only to the occupied stations." |
| Purging excess cleaner/lubricant | "After cleaning and lubrication cycle a burst of compressed air is forced into the high speed handpiece or electric micromotor attachment to purge the instrument of excess cleaner, lubricant and debris." |
| Electrical Safety | Similar to predicate devices (IMPLIES meeting safety standards, but no specific performance stated) |
| Mechanical Safety | Identical to predicate devices (IMPLIES meeting safety standards, but no specific performance stated) |
| Biocompatibility | Identical to predicate devices (IMPLIES meeting relevant standards, but no specific performance stated) |
| Chemical Safety | Identical to predicate devices (IMPLIES meeting relevant standards, but no specific performance stated) |
Missing Information: The document does not provide quantifiable acceptance criteria (e.g., "removes X% of old lubricant," "lubricates sufficiently to extend handpiece life by Y%," or specific technical performance metrics for cleaning/lubrication efficacy). Performance is generally described in terms of its intended function and similarity to predicate devices, not through specific test results against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. This 510(k) summary does not describe a clinical or performance study with a defined test set of units or handpieces.
- Data Provenance: Not applicable, as no specific performance data from a "test set" is presented. The document focuses on technological comparison to predicate devices, not primary performance data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
- Not applicable. This is not a study involving expert-established ground truth. The demonstration of safety and effectiveness relies on substantial equivalence to existing predicate devices, rather than a new clinical or performance study requiring expert adjudication of outcomes.
4. Adjudication Method for the Test Set
- Not applicable. There is no described test set or adjudication process in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is typical for diagnostic imaging devices involving human readers, which is not the nature of the StarCare Handpiece Maintenance Unit.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a mechanical unit, not an algorithm. Therefore, no standalone algorithm performance study would be relevant or discussed. The device's performance is intrinsically linked to its physical operation and interaction with the dental handpieces.
7. Type of Ground Truth Used
- Not applicable. For this type of device and submission, "ground truth" in the sense of expert consensus, pathology, or outcomes data is not utilized to demonstrate equivalence. The "ground truth" for a 510(k) submission generally refers to the established safety and effectiveness of the predicate devices to which the new device is compared. The claim is that the new device is "substantially equivalent" in its performance, intended use, and technological characteristics to devices already cleared for market.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" for this device, as it is a mechanical unit, not an AI/ML algorithm or a diagnostic tool that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, for the same reasons as point 8.
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