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510(k) Data Aggregation
(218 days)
Synea Fusion Handpieces (Intensiv & Profin)
The reciprocating/oscillating contra-angle handpieces are for the following applications: Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics.
W&H's reciprocating/oscillating handpieces were developed as dental contra-angle handpieces that are powered by either an air motor or an electric micromotor. The internally mounted gearing elements transmit the supplied rotational movement up to the head-side assembly holding the clamped tool and generating its reciprocal movement. Because of being designed for two different manufacturers´ files/tips (tools), the following types have been developed: the Synea Profin handpieces WG-67 LT and WG-67 A, intended to be provided with tips/files offered by the Swedish company Dentatus AB (Establishment Reg. No. 8030870) and the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A (incl. Swiss Edition for WG-69 A and WG-69 LT), intended to be provided with tips/files offered by the Swiss manufacturer Intensiv SA (Establishment Reg. No. 8030958). All these devices´ application is intended in dentistry.
The provided text is a 510(k) Premarket Notification summary for dental handpieces. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence of the new Synea Fusion Handpieces to a legally marketed predicate device (K082827) based on non-clinical testing for mechanical, material, and reprocessing characteristics, as well as biocompatibility.
Here's what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with reported performance values in the way one would for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, it states that "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K082827)."
The acceptance criteria are implied by the standards applied and the successful completion of the tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 14457:2017 "Dentistry - Handpieces and motors" | Functional testing of the new handpieces to test the application, settings, and features per the device specifications requirements was performed, demonstrating performance as intended. This implies the device met the mechanical and functional requirements of this standard. |
| Biocompatibility according to ISO 10993-1 and ISO 7405 | "An evaluation of biocompatibility according to ISO 10993-1 was performed." This implies the device met the biocompatibility requirements, indicating no unacceptable biological response. |
| Reprocessing Validation according to FDA Guidance and specific ISO standards (ISO 17664, ANSI/AAMI ST79, ISO 17665-1) | "Reprocessing validation was provided per the FDA Guidance Document for 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. Cleaning and sterilization validation was performed for the new handpieces." This indicates the device can be safely reprocessed, meeting the methods and acceptance criteria defined within those standards and guidance. |
| Risk Assessment according to ISO 14971 | "Risk Assessment according to ISO 14971:2007." This implies that risks were identified, evaluated, and controlled to an acceptable level as per the standard. |
| Durability/Lifetime, Torque, Functionality, Chemical Resistance, and Packaging Stability | "Additionally, different further tests, such as material tests (reg. chemical resistance), lifetime tests, torque and functionality test and tests for ensuring the stability of packaging were performed house-internally and confirmed the product's suitability for the use in practice." This implies the device met internal performance specifications for these characteristics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided in the document, as the testing was non-clinical (laboratory/bench testing) of physical devices, not data from patients for an AI/ML diagnostic system. There were no "test sets" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth as typically understood for AI/ML diagnostic devices (e.g., radiologist reads, pathology) was not established for this type of device (dental handpieces). The "truth" for the performance criteria established was based on engineering specifications and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a human-reader based study for diagnostic accuracy.
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. No MRMC study was conducted, as this is not an AI-assisted diagnostic device. The document explicitly states "Clinical performance testing was not conducted."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, "ground truth" refers to the established engineering specifications and validated test methods defined by the applied ISO standards and internal procedures. For example:
- Mechanical/Functional: Compliance with force, speed, and dimensional tolerances as defined by ISO 14457.
- Biocompatibility: Absence of toxic or adverse biological reactions based on validated assays defined by ISO 10993-1 and ISO 7405.
- Reprocessing: Successful elimination of microbial load and retention of functional integrity after reprocessing cycles, validated according to ISO 17664, ANSI/AAMI ST79, and ISO 17665-1.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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