(93 days)
The MS system (Provisional) is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
The MS system (Provisional) is a dental implant system made of titanium metal intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to seve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. It has a screw-formed one piece of fixture and abutment made of Titanium Alloy Ti-6AL-4V (ASTM F 136) ELI with diameter 1.8, 2.5mm and length 10, 13, 15mm It has machined surface, and is supplied sterile.
I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) summary for a dental implant system (MS system Provisional) and primarily focuses on establishing substantial equivalence to predicate devices. It describes the device, its intended use, contra-indications, and confirms that safety and performance validations were conducted.
However, it does not include:
- Specific acceptance criteria: There is no table or explicit listing of performance metrics and their target values.
- Reported device performance: While it states "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations," it does not provide the results of these tests or any quantitative performance data.
- Details about the study that proves the device meets acceptance criteria: There is no description of a clinical or technical study, its methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance: These are not applicable as the device is a physical dental implant, not an AI or imaging diagnostic tool.
- Sample sizes for test or training sets, or how ground truth was established for these datasets.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details about the study, sample sizes, experts, adjudication, or ground truth. The document confirms that "extensive safety, performance, and product validations" were done and "appropriate safeguards have been incorporated," but it does not elaborate on the specifics of these validations or present data.
§ 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.