(429 days)
Indications are widespread in the field of Surgery, Implantology and Endodontic treatment.
- Surgery: 1059, 5050, 5051, 5055, 5056, 5060, 5062, 5063, 5068, 5070, 5075
- . Endodontic treatment: 5057, 5059, 5061, 5066, 5067, 5069, 5071, 5076
- . Speed Increaser Contra-Angle: 5081 The device is intended for use where high speed such as 200'000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates
All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling.
All mentioned NOUVAG Contra-Angle Attachments Dental are attachments for surgical drive units. They are designed to transmit rotational movement of the motor axle of such drive units to the shank of a bur which will be inserted into the output end of the handpiece.
For this application, all these Contra-Angle Attachments contain a coupling part fittable to all surgical motors with a coupling according to ISO 3964.
The output end of the Contra-Angle Attachments contains chuck systems for accommondation of standardized bur shanks. All mentioned NOUVAG Contra-Angle Attachments Dental are designed for burs according to ISO 1797 shank-type 1.
The provided text is a 510(k) submission for NOUVAG Contra-Angle Attachments Dental. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way envisioned for a typical AI/software device.
The submission focuses on demonstrating substantial equivalence to existing legally marketed dental handpiece attachments. The "performance" aspect mentioned refers to compliance with established international standards for mechanical characteristics and usability, rather than performance in terms of diagnostic accuracy or clinical outcomes as would be relevant for an AI study.
Therefore, I cannot fulfill the request in the format provided because the information is not present in the input document.
Here's a breakdown of why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance. Instead, the submission implies acceptance criteria are met by conforming to existing international standards for dental instruments (ISO 7785-2, ISO 3964, ISO 10993-1/-5/-12).
- Reported Device Performance: The "Performance" row in the TABLE 1 TECHNOLOGICAL COMPARISON refers to compliance with ISO 7785-2 and ISO 3964. This indicates the device meets the mechanical and functional specifications outlined by these standards, making it comparable to the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a traditional medical device (mechanical dental handpiece attachments), not an AI/software device. There is no "test set" of data in the AI sense for clinical validation. Testing would primarily involve mechanical and material property verification against the aforementioned ISO standards.
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):
- Not applicable. No ground truth establishment for a diagnostic or clinical AI application. The "ground truth" for this device would be its adherence to engineering specifications and international standards, likely verified by engineers or quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a clinical test set.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the AI sense. The "ground truth" for this device's safety and effectiveness is its compliance with established engineering standards (ISO) and its substantial equivalence to predicate devices already on the market.
8. The sample size for the training set:
- Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
In summary: The provided 510(k) notification is for a mechanical medical device and therefore does not contain the types of information requested concerning AI acceptance criteria, studies, and data sets. The equivalence is demonstrated through comparison of material, design, intended use, and compliance with recognized performance standards to predicate devices.
§ 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.