(113 days)
The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
Dental Handpiece Cleaner and Lubricant (Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, and EZcare Handpiece Cleaner & Lubricant), This is an aerosol product that is used during routine maintenance. It contains two major components, which are Mineral oil and Isopropyl Alcohol. The product lubricates and cleans dental handpieces and air motors when sprayed directly into the air drive tube. It lubricates and cleans out contamination from all internal parts, such as the bearings, gears and auto chucks.
Dental Handpiece Lubricant: Maxima Handpiece Lubricant contains mineral oil that drops directly into the air drive tube of the dental handpiece. When the user operates the handpiece, the pressure of air in the air drive tube will deliver the oil into the handpiece to lubricate the bearings, gears, and auto chucks.
The provided document is a 510(k) premarket notification for dental handpiece cleaners and lubricants. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria and proving performance against them in the same way a de novo device might.
Here's an analysis based on the document, addressing the requested points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define specific quantitative "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, it relies on demonstrating that the subject devices perform comparably to a legally marketed predicate device. The "acceptance criteria" are implicitly that the subject device's performance in the specified tests is equivalent to or better than the predicate device's performance, allowing it to meet its design performance requirements.
| Comparison | Test | Method | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Spray & Clean Handpiece Cleaner & Lubricant vs. NSK Pana Spray | Handpiece Performance Testing | Cycle ( unspecified number of cycles) | ||
| Bur extraction force, | ||||
| concentricity, | ||||
| noise level, and torque | Performance characteristics (bur extraction force, concentricity, noise level, torque) are comparable to the predicate. | "Met handpiece performance specification" (implies equivalence to predicate) | ||
| Maxima Handpiece Lubricant vs. NSK Pana Spray | Handpiece Performance Testing | Cycle (unspecified number of cycles) | ||
| Bur extraction force, | ||||
| concentricity, | ||||
| noise level, and torque | Performance characteristics (bur extraction force, concentricity, noise level, torque) are comparable to the predicate. | "Met handpiece performance specification" (implies equivalence to predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set (i.e., the number of handpieces or test iterations). It simply states that "performance testing... was conducted on the subject devices and the predicate device."
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a device like this, it is likely that the testing was conducted prospectively by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not relevant for 510(k) submissions of accessories like handpiece lubricants. The "ground truth" here is objective physical and mechanical measurements of handpiece performance, not subjective expert assessment of clinical outcomes or images. Therefore, no experts were used in this capacity.
4. Adjudication Method for the Test Set:
Not applicable, as the "ground truth" is based on objective measurements, not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human reader performance is a key metric. This device is a maintenance product for dental equipment.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is not an algorithm or an AI system. It is a physical product (lubricant). Performance is evaluated based on its effect on the mechanical function of dental handpieces.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical testing was based on objective physical and mechanical measurements. Specifically, the test evaluated:
- Bur extraction force
- Concentricity
- Noise level
- Torque
These are measurable performance specifications for dental handpieces, which are expected to be maintained or improved by the lubricants.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.