(80 days)
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
The ANKYLOS® Dental Implant System consists of threaded dental implants in 3.5 - 7.0 mm diameters with 8 - 17 mm lengths. The implants are coated with the FRIADENT Surface. The ANKYLOS® Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. In the edentulous mandible, the ANKYLOS® dental implants are indicated for immediate loading procedures using the standard protocol.
The provided text is a 510(k) summary for the FRIADENT GmbH ANKYLOS® Dental Implant System. It outlines the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, F1-score, etc.).
Medical devices, especially hardware like dental implants, are regulated differently from AI/ML software. For devices like dental implants, "performance evaluation" typically refers to:
- Mechanical Strength and Durability Testing: Ensuring the implant can withstand masticatory forces over time.
- Biocompatibility Testing: Confirming the materials are safe for implantation in the human body.
- Sterilization Validation: Ensuring the device can be properly sterilized.
- Clinical Studies (if required): For novel designs or indications, clinical trials might be conducted to demonstrate safety and effectiveness in human subjects, often focusing on outcomes like integration success rates, survival rates, and complication rates.
- Comparison to Predicate Devices: Demonstrating that the new device performs "as well as" or "substantially equivalent" to a legally marketed predicate device, often through a combination of the above testing and analysis of existing literature on the predicate.
The document states: "Performance evaluations of the ANKYLOS® dental implant system show that the device performs as intended. Comparison of the ANKYLOS® dental implant system to the predicate devices shows that the device is substantially equivalent." This suggests that the "study" referred to is likely a compilation of engineering tests and comparative analysis rather than a human-in-the-loop AI performance study.
Therefore, I cannot provide the requested information for an AI/ML device performance study using this document. The questions you've asked are specific to AI/ML device validation, which is not covered in this 510(k) submission for a dental implant system.
To answer your request based solely on the provided text, I must state that the information is not present in the document.
§ 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.