(199 days)
The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.
A cylinder shaped commercially pure titanium dental implant with external threads.
The provided text describes a 510(k) summary for a dental implant, "O" Butment ET Implant, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/software or a diagnostic device.
Therefore, I cannot fulfill the request as the provided input does not contain any of the required information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study.
- Standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses:
- Device Type: Dental Implant
- Purpose of 510(k): Substantial Equivalence
- Comparison Basis: Design, function, labeling, material composition, and intended use compared to predicate devices.
- Non-clinical tests: Lateral and vertical stress analysis, concluding physical integrity has not been compromised by modifications.
This is a traditional medical device approval document, not one related to software or AI performance assessment.
§ 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.