(77 days)
The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used.
The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access.
The device is intended for use with all friction-grip burs, including surgical length burs, that conform to I.S.O. and A.D.A. shank diameter standards (0.0626 to 0.0630 inches). The recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"), which results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). The device includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. The use of sterile water is recommended. One model of the device also includes a fiberoptic bundle that directs light onto the working area.
The device may be connected to a standard compressed air source found in virtually all dental units. The use of filtered air is recommended. The air supply enters the device through a tube in the handle and turns the turbine, which is in the head of the device, thus spinning the bur. The air exits the device principally through an air exhaust tube in the handle. A smaller portion of the air exits through the top of the head of the device. Virtually no air exits from the front of the head into the area of the bur.
The Impact Air 45 can be sterilized by autoclave when processed for 35 minutes at 250 degrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.
The provided text is a 510(k) summary for the Impact Air 45 Handpiece for Endodontic Use. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.
Therefore, many of the requested categories (such as sample size, expert qualifications, and detailed performance metrics) are not explicitly stated in this type of regulatory submission. The primary "study" described is a testing of sterilization cycles.
Here's the information that can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization Durability: Continue to function appropriately after sterilization cycles. | After 250 sterilization cycles, the handpiece continues to function appropriately. |
| Material/Design Conformance: Use with ISO/ADA standard friction-grip burs (0.0626 to 0.0630 inches). | Intended for use with all friction-grip burs, including surgical length burs, that conform to I.S.O. and A.D.A. shank diameter standards. This indicates compliance with the criteria. |
| Operating Conditions: Recommended operating air pressure (32-40 psi). | The recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"). This indicates compliance with the criteria. |
| Rotational Speed: High-speed bur rotation (400,000 to 500,000 rpm). | Results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). This indicates compliance with the criteria. |
| Air Direction: Air not directed onto the area of the bur. | Designed so that air is not directed onto the area of the bur. Virtually no air exits from the front of the head into the area of the bur. This indicates compliance with the criteria. |
| Access: 45-degree back-angled head shank to facilitate access. | Designed with a 45-degree back-angled head shank to facilitate access. This indicates compliance with the criteria. |
| Cooling/Irrigation: Water line directs water onto the spinning bur. | Includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. This indicates compliance with the criteria. |
| Sterilization Method: Able to be sterilized by autoclave. | The Impact Air 45 can be sterilized by autoclave when processed for 35 minutes at 250 degrees. This indicates compliance with the criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size for Sterilization Testing: Not explicitly stated, however, the statement "Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately" implies at least one device was tested and subjected to 250 cycles. The exact number of units tested is not provided.
- Data Provenance: Not specified, but likely internal testing by the manufacturer (Palisades Dental A Division of Glenwood, L.L.C.) given the nature of the submission. The country of origin for the data is not mentioned, but the manufacturer is based in Tenafly, NJ, USA. The testing would be considered "prospective" for the specific test conducted (sterilization cycles).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for this type of device and submission. The "ground truth" here is objective physical performance (e.g., functioning after sterilization, bur rotation speed, air pressure). Expert consensus is not relevant for these technical specifications.
4. Adjudication method for the test set
- Not applicable. Performance metrics for mechanical devices generally do not require adjudication.
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 device is a dental handpiece, not an AI-powered diagnostic or assistive tool for human readers/clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (See point 5). This is a mechanical device, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical function.
7. The type of ground truth used
- Objective Device Performance Data: For the sterilization test, the ground truth is simply whether the device "continues to function appropriately" after the specified number of cycles. For other specifications (e.g., bur size compatibility, operating pressure, RPM), the ground truth is defined by engineering specifications and standards (I.S.O. and A.D.A. shank diameter standards).
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.