(215 days)
The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.
The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.
The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM.
The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.
The DentalEZ Inc., StarDental Division 430 SWL 45 and 430 SW 45 High-Speed Handpieces are dental devices, not an AI or imaging device. Therefore, much of the requested information, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.
Here's the available information based on the provided text, focusing on the acceptance criteria and the studies performed to demonstrate equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not list specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the devices were developed considering applicable technical standards and internal specifications, and their conformance was verified through bench testing. The comparison to predicate devices focuses on similarity in characteristics rather than meeting defined performance thresholds.
| Technological Characteristics | Predicate Device Comparison Conclusion | Study/Verification Method |
|---|---|---|
| Indication for use | Similar | (Implied through intended use statement and overall submission) |
| Target population | Identical | (Implied through intended use statement and overall submission) |
| Design | Similar | Bench testing in TR 468, TR 470 |
| Materials | Identical | (Implied) |
| Performance | Similar | Bench testing in TR 468, TR 470 |
| Sterility | Identical | Sterilization validation (HIGHPOWER Validation Testing & Lab Services) |
| Biocompatibility | Identical | (Implied by regulatory standards/predicate comparison) |
| Mechanical safety | Identical | Bench testing (ISO 14971:2009 for Risk Analysis) |
| Chemical safety | Identical | (Implied by regulatory standards/predicate comparison) |
| Energy used and/or delivered | Identical | (Implied) |
| Compatibility with environment and other devices | Identical | (Implied) |
| Where used | Identical | (Implied) |
| Standards met | Similar | Bench testing, conformance to ISO 7785-1, ANSI/AAMI ST79, AAMI/ANSI/ISO 14937 |
| Electrical Safety | Not applicable | (Device is air-powered) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this device and study type. Clinical data or test sets as typically understood for AI algorithms are not mentioned. The "tests" referenced are bench tests of the device itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" for this device's performance is established by industrial standards, internal specifications, and physical measurements during bench testing, not expert consensus on medical images or patient outcomes.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is relevant for AI-assisted diagnostic tools. The provided document describes a dental handpiece, not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This describes a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by:
- International Standards: e.g., ISO 7785-1, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, AAMI/ANSI/ISO 14937:2009, ISO14971:2009.
- StarDental Internal Specifications: Used in the development and testing documentation (TR 468, TR 470).
- Physical Measurements and Bench Testing Results: Directly observed performance characteristics during testing.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
Studies that Prove the Device Meets Acceptance Criteria:
The acceptance criteria are implicitly met through the following non-clinical studies and comparisons:
- Bench Testing (TR 468): This internal test was developed to determine the performance characteristics of the handpieces, considering StarDental internal specifications and ISO 7785-1, 1997-08-01. This demonstrates the device's mechanical and operational performance against established standards.
- Bench Testing (TR 470): This internal test focused on the effectiveness of housing pressure relief slots and the vortex washer, and quantified the air bleed of the handpiece head. It also compared these characteristics with predicate devices. This shows functional design and safety aspects.
- Sterilization Validation Studies: Performed by HIGHPOWER Validation Testing & Lab Services, these studies confirmed the effectiveness of sterilization and dry times. They followed ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 and AAMI/ANSI/ISO 14937:2009, ensuring the device meets critical infection control requirements.
- Risk Analysis (ISO14971:2009): A risk analysis was conducted according to this standard, indicating that potential risks were identified and mitigated, contributing to the device's safety.
- Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the proposed devices are "substantially equivalent" to predicate devices based on similarities in intended use, principles of operation, and functional design. This implies that the performance and safety are comparable to already approved devices. The FDA concurred with this assessment in their letter.
§ 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.