(90 days)
For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.
This document is a 510(k) summary for a dental implant system (ThreadLoc Dental Implant System). It serves to demonstrate substantial equivalence to a predicate device. The information provided is not relevant for characterizing device performance based on acceptance criteria from a clinical or diagnostic study for an AI-powered device.
Here's why and what information is missing based on your request:
- Device Type: This is a physical medical device (dental implant), not an AI-powered diagnostic or assistive technology. The acceptance criteria and performance metrics you're asking about (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are specific to AI/software as a medical device (SaMD) used for analysis, diagnosis, or prediction.
- Study Type: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, often through technological characteristics and intended use, rather than presenting clinical trial data that establishes performance against specific acceptance criteria in the way an AI/SaMD device would.
- Data Provided: The document details changes to the physical implant (self-tapping capabilities, surface textures) and states the intended use is identical to the predicate. It does not contain any performance metrics for diagnostic accuracy, classification, or human reader improvement.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, performance metrics, sample sizes, ground truth, or MRMC studies because the provided document does not contain this type of information for an AI/SaMD.
To answer your request for an AI-powered device, the input document would need to describe a study evaluating the diagnostic or assistive performance of an AI algorithm, including details like:
- Clinical study design and outcomes.
- Performance metrics (e.g., sensitivity, specificity, accuracy, F1-score, AUC).
- Pre-defined acceptance criteria for these metrics.
- Details about the test dataset (size, provenance, ground truth establishment, adjudication).
- Information on training data and methods.
- Results from standalone performance (if applicable) or human-in-the-loop studies (e.g., MRMC studies).
§ 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.