(238 days)
OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.
The OsseoSpeed™ Profile is a self-tapping, threaded, root-formed dental implant, intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a microroughened and fluoride-modified surface, designated OsseoSpeed. It includes a contoured coronal margin that mimics the contour of alveolar bone and is designed to create a more desirable esthetic effect.
The provided text is a 510(k) summary for the OsseoSpeed™ Profile dental implant and a subsequent FDA clearance letter. It describes the device's intended use and classification, and states that it is substantially equivalent to predicate devices. However, this document does not contain information about specific acceptance criteria or an analytical study with performance metrics.
Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training/test set ground truth establishment.
The document primarily focuses on:
- Device Description: Self-tapping, threaded, root-formed dental implant made from titanium with a microroughened and fluoride-modified surface, designed for supporting prosthetic devices. It also notes a contoured coronal margin for esthetic effects.
- Intended Use: To replace missing teeth in single or multiple unit applications, usable in single-stage or two-stage surgical procedures, indicated for immediate implantation in extraction sites or healed alveolar ridges. It can be immediately loaded when primary stability is achieved. It is also indicated for use in soft bone applications.
- Substantial Equivalence: The manufacturer demonstrated the device is substantially equivalent to predicate devices for its indications and design principles.
Missing Information:
The document lacks critical experimental data typically found in a clinical study report or a more detailed 510(k) submission that would include performance testing. To answer your questions, I would need a document that presents:
- Specific performance metrics and their acceptance thresholds. (e.g., success rate, survival rate, bone loss measurements, ISQ values, etc.)
- Details of a study conducted to demonstrate these metrics. This would include information on the study design, patient population, data collection, and statistical analysis.
§ 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.