(124 days)
The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease.
The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment.
The Dental Air Polishing Handpiece, AP-H Plus is an air driven dental handpiece for the use by a trained professional in the field of supragingival and the subgingival treatment. The devices are air-powered handpieces that are reusable.
The proposed Dental Air Polishing Handpiece, AP-H Plus device is similar in design to the predicates AIR-FLOW handy 3.0 PLUS (K151912) . The proposed Dental Air Polishing Handpiece, AP-H Plus device and the predicates connect to a standard air turbine connection on a dental operative unit and deliver a mixture of water, air, and prophylaxis powder to a treatment site. The subject Dental Air Polishing Handpiece is comprised of a supragingival handpiece (model: AP - 1 Plus) a subgingival handpiece (model: AP - 2 Plus), spray head, nozzle, powder storage chamber, and tail cord connector.
This document is a 510(k) Pre-Market Notification from the FDA regarding a dental device, which generally does not contain the detailed performance data or clinical study results required for medical imaging AI/ML devices. Therefore, a complete description of the acceptance criteria and study that proves the device meets the criteria, as requested, cannot be fully provided from the given information.
However, I can extract the information related to performance testing that was deemed sufficient for substantial equivalence for this device, which might be interpreted as meeting "acceptance criteria" for the specific context of this device's regulatory pathway.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) or direct reported device performance in the manner typically seen for diagnostic AI/ML models. Instead, it indicates compliance with recognized standards.
| Acceptance Criteria Category | Standard / Requirement | Reported Device Performance |
|---|---|---|
| Performance | ISO 20608:2018 Dentistry - Powder jet handpieces and powders | "The results of these tests demonstrate compliance with the requirements of the consensus standards noted below." (implies compliance with ISO 20608) |
| Hose Connectors | ISO 9168 Dentistry - Hose connectors for air driven dental handpieces i | "The results of these tests demonstrate compliance with the requirements of the consensus standards noted below." (implies compliance with ISO 9168) |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices | "Performed to ensure compliance" (implies compliance) |
| ISO 10993-5 Cytotoxicity Tests | "Performed to ensure compliance" (implies compliance) | |
| ISO 10993-10 Skin Irritation test | "Performed to ensure compliance" (implies compliance) | |
| ISO 10993-10 Oral Mucosa Irritation test | "Performed to ensure compliance" (implies compliance) | |
| ISO 10993-10 Sensitization Test | "Performed to ensure compliance" (implies compliance) | |
| Sterilization Validation | ANSI AAMI ST79:2017 (Steam sterilization) | "Validated as below" (implies successful validation) |
| ISO 17665-1:2006 (Moist heat sterilization) | "Validated as below" (implies successful validation) | |
| Cleaning Method | AAMI TIR30 | "Has been validated" (implies successful validation) |
| Disinfection Method | AAMI TIR12 | "Has been validation" (implies successful validation) |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document describes performance testing against engineering and biocompatibility standards, not a "test set" of clinical cases or data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on clinical findings) is not relevant for the type of testing described here.
4. Adjudication Method for the Test Set:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML device for diagnostic interpretation. The device is a "Dental Air Polishing Handpiece."
6. Standalone (Algorithm Only) Performance:
No, as this is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
For the performance testing, the "ground truth" would be the established requirements and specifications of the referenced international standards (e.g., ISO 20608, ISO 10993, ANSI AAMI ST79). For example, for biocompatibility, the ground truth is whether the device materials elicit a cytotoxic, irritant, or sensitizing response according to the defined protocols in the ISO 10993 series.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that undergoes a "training set" process.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.