(212 days)
The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.
The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.
The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished.
The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.
Subject to this submission are the following implant variations:
BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm
TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm
TL RP Conical Ø4.1 mm, L 10 mm
The provided text is a 510(k) summary for a medical device (Dental Implants OKTAGON® Tissue Level and Bone Level). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of algorithm performance for an AI/ML powered device. The "performance tests" mentioned refer to fatigue tests against ISO 14801 for mechanical properties of dental implants, not AI/ML algorithm evaluation.
Therefore, I cannot extract the requested information as it does not exist within the provided document.
To be explicit, the following information is not present in the document:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (for an AI/ML algorithm).
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to the regulatory submission for a physical medical device (dental implants), not a software-as-a-medical-device (SaMD) or an AI/ML-powered medical device.
§ 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.