(190 days)
The Olympus Dental Implant System is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability.
The Olympus Dental Implant System includes various sizes of parallel sided, threaded, root-form dental implants and straight abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stobility is reached according to the Instructions for Use, Olympus Dental Implants with an insertion depth of 8 mm or more may be immediately loaded. The system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components (Class 1 exempt, not a subject of this submission) intended to facilitate the prevaration of prosthetic restorations.
This document describes the Olympus Dental Implant System, which is a Class II medical device. The information provided outlines its intended use and describes its equivalence to already marketed devices, but it does not include a study describing acceptance criteria or performance metrics in the way one might find for a diagnostic or AI-driven device.
Therefore, I cannot populate the table or answer most of the questions as the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and detailed test results.
Here's an explanation based on the provided text:
- Type of Device: The Olympus Dental Implant System is a physical dental implant system, not a diagnostic or AI-powered software device.
- Regulatory Pathway: The submission is a 510(k) premarket notification. This pathway primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for novel performance metrics.
- Lack of Performance Study Data: The provided text does not contain any sections detailing a study with acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies. The "DEVICE DESCRIPTION" and "EQUIVALENCE TO MARKETED PRODUCT" sections confirm this focus on equivalence in design and indications for use.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of submission.
- Sample size used for the test set and the data provenance: No performance study described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study described.
- Adjudication method for the test set: No performance study described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical implant, not an AI or diagnostic tool.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: No training set for an algorithm described.
- How the ground truth for the training set was established: No training set for an algorithm described.
Summary of available information:
- Device Name: Olympus Dental Implant System
- Intended Use: "To be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability."
- Regulatory Classification: Class II (Endosseous dental implant - 21 CFR 872.3640; Endosseous dental implant abutment - 21 CFR 872.3630).
- Equivalence: The manufacturer "demonstrated that... the Olympus Dental Implant System is substantially equivalent in indications and design principles to predicate devices."
The 510(k) process for devices like dental implants primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, materials testing, and comparison of design features, rather than extensive clinical performance studies with specific numerical acceptance criteria for diagnostic accuracy or algorithmic performance as would be seen for AI/ML devices.
§ 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.