(157 days)
Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or intermediate abutment support for fixed or removable bridgework and to retain overdentures.
The Biodenta Dental Implant System - Bone Level is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and prosthetic parts and related surgical instruments.
The provided text describes a 510(k) premarket notification for the Biodenta Dental Implant System - Bone Level. This document primarily focuses on demonstrating substantial equivalence to predicate devices and includes non-clinical testing data (fatigue testing). It does NOT describe an AI/ML powered medical device, nor does it contain information regarding acceptance criteria or a study that typically involves these concepts for AI/ML devices.
Therefore, the requested information cannot be extracted from the provided text as it pertains to a traditional medical device (dental implant) that does not utilize AI/ML.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "sufficient mechanical strength" based on fatigue testing, but there are no specific numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/ML device evaluations (e.g., sensitivity, specificity thresholds).
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical dental implants used in fatigue testing, not a dataset for an AI model. The document mentions "worst case scenario" for the implants but no sample size for a test set in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This is irrelevant for a physical dental implant.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among experts on ground truth for AI datasets. This is not mentioned as the device is not AI-powered.
- 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. MRMC studies are specific to evaluating AI's impact on human performance in diagnostic tasks. This device is an implant, not a diagnostic tool assisted by AI.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for AI is not relevant here. The "proof" for this device lies in its physical properties and mechanical strength demonstrated through non-clinical testing.
- The sample size for the training set: Not applicable. This device does not involve a training set for an AI model.
- How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI model.
§ 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.