(90 days)
Not Found
The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures. All components are manufactured from surgical grade stainless steel.
This appears to be a 510(k) summary for a dental prosthetic instrument (AS 123 Prosthetic Instrument System) from 1996, not a medical device involving AI or complex performance metrics requiring such studies.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this submission.
Here's why:
- Device Type: The AS 123 is a hand-operated tool for installing and removing dental implant components. It's a mechanical device, not an image analysis system, AI-driven diagnostic tool, or a device that produces quantitative outputs that would typically require the kind of performance studies you're asking about.
- Submission Date: The submission date is 1996. The types of rigorous statistical studies, AI performance metrics, and complex ground truth establishment methodologies you describe were not commonplace or even relevant for this type of device at that time (or even now, for such a simple mechanical instrument).
- Substantial Equivalence: The submission focuses on demonstrating substantial equivalence to existing predicate devices (Steri-Oss® "Prosthetic Instrumentation" and Implant Innovations, Inc. "Drivers and Placement Instruments"). This typically involves comparing features, materials, and intended use, rather than conducting new performance trials against a defined set of acceptance criteria in the manner you've outlined for AI-driven devices.
In summary, for K963951, the information requested is entirely out of scope for this type of device and regulatory submission.
§ 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.