(218 days)
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The Posi-Stop/Posi-Trac System is designed for use with or without a surgical guide. The system allows the dental practitioner to increase size gradations in 0.5mm steps for final sizing for implant type customization. The system is truly generic in that its 0.5mm size gradations allows the doctor to switch to a final sizing drill for implant type customization.
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The system is designed for use with or without a surgical guide and allows for size gradations in 0.5mm steps for final sizing for implant type customization. The system includes a 1.6mm starter drill, Posi-Trac drills, and Posi-Stop instruments. The 1.6mm drill is the only depth cutting instrument, while the remaining drills cut only on the outer 0.5mm to prevent excessive depth penetration. The Posi-Trac drill has a pilot end of 1.6mm and is used to widen the osteotomy. The Posi-Stop instrument is utilized until the correct width is achieved. The Posi-Stop can be adjusted along a track guide. The 2.0 - 4.5mm sizes are safety ended.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental medical device. It does not contain any information about acceptance criteria or a study that proves the device meets specific criteria (such as performance metrics, sample sizes, expert qualifications, or ground truth establishment).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document focuses on regulatory approval and classification, not on the technical performance study details.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.