(88 days)
The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.
The Bien-Air ORL-E-92 Surgical Drill System is a series of components used in implantology and microsurgery. The system consists of a foot pedal control unit, BASCH electric micromotor and cable and transformer. Several models of straight and contra-angled microsurgery handpieces are available for use with the ORL-E-92 system. A separate irrigation system consisting of peristaltic pump, irrigation tubing and solution supports complements the ORL-E-92 system.
The Bien-Air ORL-E-92 Surgical Drill System is a Class I device and, as such, no formal performance data was submitted to prove the device meets acceptance criteria. The submission indicates that "sterilization certification of the product by steam sterilization was provided." This suggests that the primary acceptance criterion related to performance was likely the successful sterilization of the device by steam.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization | Sterilization certification by steam sterilization was provided. |
| Functionality | Not explicitly detailed, but implied to be equivalent to predicate devices (speed, rotation, irrigation, autoclavability). |
2. Sample size used for the test set and the data provenance
No formal performance data was submitted, so there is no information regarding a specific test set, its sample size, or data provenance. The submission focuses on substantial equivalence to predicate devices and sterilization certification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no formal performance study with a test set requiring expert ground truth was conducted or submitted.
4. Adjudication method for the test set
Not applicable, as no formal performance study with a test set was conducted or submitted.
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 device is a surgical drill system, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical drill system, not an algorithm.
7. The type of ground truth used
For sterilization, the "ground truth" would be the successful validation of the sterilization process as per industry standards and regulatory guidelines, and its certification. For the functional aspects, the ground truth for substantial equivalence was the comparison to the existing predicate devices.
8. The sample size for the training set
Not applicable, as no algorithm or machine learning model was developed for this device.
9. How the ground truth for the training set was established
Not applicable, as no algorithm or machine learning model was developed for this device.
§ 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.