(13 days)
The STRONG Dental Handpieces is indicated for wide range of dental procedures.
- AT II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
- ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower ● jaw, germectomia, sequestrotomia.
The STRONG Dental Handpieces; AT-II, ACL-01C, ACL(B)-01C and ACL-02C is The STRONG Dental handpieces with transmission ratio of 1:1. It can be driven by torque adjustable electrical motors for surgery treatment. It is attached to drive via ISO 3964 coupline. The head clamp accepts instrument complying with ISO 1797-1. It has contra-angle(AT-II has straight-angle) attachment for difficult to reach 1797-1. It has contra digities for restorations, such as fillings, and for cleaning teeth.
The provided text is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific acceptance criteria for an AI/machine learning device. Therefore, a direct answer to the request to describe acceptance criteria and a study proving device performance in the context of AI/machine learning is not possible from this document.
The document discusses the device's indications for use and compares its characteristics to predicate devices. It states:
- "The STRONG Dental Handpieces has the same device characteristics as the predicate The Surgical Contra-Angle handpieces Types WS-56E, Surgical Straight Handpieces Types S-11; intended use, material, design and use concept are similar. And they also comply to ISO 3964 coupling and ISO 1797-1 shank."
- "Based on the comparison of intended use and technical features, the STRONG Dental Handpieces are substantially equivalent to the predicate devices."
This indicates that the "study" conducted for this medical device was a substantial equivalence comparison to predicate devices, not a clinical or performance study with acceptance criteria as one would expect for an AI/ML diagnostic or measurement tool.
Therefore, the requested information cannot be extracted from the provided text for the following reasons:
- Acceptance Criteria and Reported Device Performance: This document does not outline specific, quantifiable acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) nor does it report performance against such criteria. The device is a mechanical tool (dental handpiece), and its acceptance is based on design, materials, and intended use being equivalent to already approved devices.
- Sample Size and Data Provenance: Not applicable, as this is not a study involving data analysis or patient data.
- Experts for Ground Truth and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable, as there is no AI assistance involved with this device.
- Standalone Performance: Not applicable, as there is no AI algorithm.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size: Not applicable, as there is no AI model to train.
- Ground Truth for Training Set Establishment: 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.