(234 days)
The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
The Tri Auto mini is an battery-driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator (which is not included in this application), the Tri Auto mini indicates the position of the file tip inside the root canal.
The provided document is a 510(k) summary for the J. Morita USA Inc.'s Tri Auto mini, an endodontic treatment motorized handpiece. It aims to establish substantial equivalence to predicate devices, rather than establishing acceptance criteria for novel device performance and proving those criteria through a study with specific performance metrics.
Therefore, the information requested in your prompt (acceptance criteria, specific study details like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this type of regulatory submission.
Here's why and what information related to performance testing is available:
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Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often done by showing similar indications for use, technological characteristics, and performance. It does not typically involve setting novel performance acceptance criteria and then conducting a new clinical study to meet those criteria as would be expected for a device with a new intended use or technology.
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Performance Testing Mentioned: The document states:
"PERFORMANCE TESTING
The Tri Auto mini was tested in accordance with IEC 60601-1, IEC 60601-1-4, UL 60601-1, CAN/CSA C 22.2 No.601.1-M90, and IEC 60601-1-2. Also, Biocompatibility, sterilization, and software validation were conducted.
Test results shows that Tri Auto mini is substantially equivalent to predicate devices."This indicates that various safety and functional standards were met, and tests related to biocompatibility, sterilization, and software validation were performed. These are standard tests for medical devices to ensure they are safe and perform as intended, but they are not specific performance metrics in the way you've outlined for AI/diagnostic devices (e.g., sensitivity, specificity, accuracy).
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Comparison to Predicate Devices: The "Comparison summary table" clarifies that the "Performance Canal Enlargement Function" of the Tri Auto mini is "Identical" to both predicate devices (Tri Auto ZX and ROOT ZX II). This implies that the performance in its stated function is considered equivalent, rather than needing to meet distinct, quantitative acceptance criteria.
In summary, the provided document does not contain the specific information you requested because it's a 510(k) submission focused on demonstrating substantial equivalence, not a study report establishing novel acceptance criteria and proving them with detailed performance metrics.
§ 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.