(161 days)
BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
BIOMET 31 NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
BIOMET 3i NanoTite Dental Implants cleared by K051461, K063341 & K063286 have both the proprietary OSSEOTITE acid-etched surface and NanoTite CaP Discrete Crystalline Deposition (DCD) surface treatment.
The devices themselves have not been modified since their original clearance. Specific performance claims for NanoTite Dental Implants are being modified. Two independent prospective randomized controlled studies provide clinical data to support the requested claims.
The provided text describes a 510(k) premarket notification for BIOMET 3i NanoTite™ Dental Implants. This is a medical device submission, and the content focuses on establishing substantial equivalence to a predicate device and supporting claims for use. It is not a study about an AI-powered device, and therefore, most of the requested information (acceptance criteria, device performance, sample sizes, ground truth, MRMC studies, standalone performance, training set details) is not applicable.
However, I can extract the relevant information regarding the device itself and the type of evidence provided:
Device: BIOMET 3i NanoTite™ Dental Implants
Classification Name: Endosseous dental implant
Product Code: DZE
Predicate Device: K051461 - 3i Osseotite (Nano CaP) Dental Implant
Study Information (as pertains to this 510(k) submission):
The submission refers to changes in "specific performance claims for NanoTite Dental Implants," which are supported by clinical data.
Description of Study:
"Two independent prospective randomized controlled studies provide clinical data to support the requested claims."
Type of Ground Truth Used: Clinical data (implied patient outcomes and immediate function assessment).
Conclusion of the Submission:
"The clinical data submitted for the NanoTite dental implant compared to the control implant supports the modifications to specific performance claims requested within this premarket notification."
Regarding your specific questions, this document does not contain the following information as it pertains to an AI/Software as a Medical Device (SaMD):
- A table of acceptance criteria and the reported device performance: This document reports modifications to performance claims, not specific quantitative acceptance criteria or performance metrics for an AI device.
- Sample sizes used for the test set and the data provenance: The document states "Two independent prospective randomized controlled studies" were conducted but does not provide sample sizes, country of origin, or specific details of the test sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable for a dental implant study. The ground truth refers to clinical outcomes.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
- The type of ground truth used: As mentioned, it's "clinical data" from patient studies, which would involve assessing implant success, immediate function, etc. This is not an expert consensus on interpreting images for an AI device.
- The sample size for the training set: Not applicable, as this is not an AI device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device.
In summary, this 510(k) document pertains to a physical dental implant device and its clinical performance, not an AI software device. Therefore, the requested information about AI model acceptance criteria, ground truth establishment by experts, and MRMC studies is not present.
§ 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.