(21 days)
ALTATEC BIOTECHNOLOGIES implants are indicated single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
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The provided text is a 510(k) clearance letter from the FDA for the "ALTATEC Camlog Screwline Implant System." This document primarily focuses on regulatory approval and substantial equivalence to a predicate device. It defines the indications for use but does not contain any information about acceptance criteria, device performance metrics, study designs (like sample sizes, data provenance, expert qualifications, or adjudication methods), or training set details typically found in a clinical or performance study report for AI/ML devices.
Therefore, I cannot extract the requested information from the provided text.
Here's why and what kind of information would be needed:
- Acceptance Criteria & Performance: This would typically involve quantitative metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical/biological thresholds) with defined pass/fail points. The provided text only lists indications for use.
- Study Design Details: Information on sample sizes, data sources (retrospective/prospective, origin), expert qualifications, and adjudication methods are standard components of a study protocol or report. This document is a regulatory approval letter, not a study report.
- MRMC Study: This is specific to AI-assisted reading and would compare human performance with and without AI. It's not applicable to a dental implant, which is a physical device.
- Standalone Performance: Again, relevant for AI algorithms, not for an implant.
- Ground Truth: For an implant, ground truth would relate to its physical properties, biocompatibility, and clinical outcomes, established through various testing methods and clinical trials. The letter does not detail these.
- Training Set: This is for machine learning models. A dental implant is a manufactured product, not an AI algorithm, so there is no "training set."
§ 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.