(12 days)
The X-CUBE is intended for use in dental surgery, implentology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
The X-CUBE, Implant Engine, is an AC-powered device that includes a hand-held motor, controller and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance, such as metrics like sensitivity, specificity, or accuracy.
The document is a 510(k) premarket notification for a medical device called "X-CUBE." The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics through a clinical study.
Here's a breakdown of why the requested information is absent and what the document does provide:
- No Acceptance Criteria or Reported Device Performance Table: The document explicitly states: "The X-CUBE has the same device characteristics as the predicate device... intended use, material, design and use concept are similar." It does not define specific performance metrics for the X-CUBE itself.
- No Clinical Study Details: There is no mention of a clinical study, test set, training set, or any of the related details (sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone performance). The device is a surgical motor unit, which for 510(k) clearance, often relies on engineering standards compliance and substantial equivalence to existing devices rather than a performance study involving human subjects or image interpretation.
- Ground Truth: Since no performance study is described, there's no mention of ground truth being established.
- Substantial Equivalence: The entire submission focuses on establishing substantial equivalence to the predicate device "ImplantMED SI-915/923 (K052741)." The conclusion clearly states: "Based on the comparison of intended use and technical features, the X-CUBE is substantially equivalent to the predicate device."
In summary, the provided text describes a device cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, rather than through a study focused on specific device performance metrics with acceptance criteria.
§ 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.