(274 days)
AR N Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR N Type Implant System is for two stage surgical procedures. It is intended for delayed load.
The AR_N Type Implant System is a dental implant system made of CP TiGr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with RBM (Resorbable Blast Media). Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.
The document provided is a 510(k) summary for a medical device called "AR N Type Implant System." It details the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, or the details of a study setup as requested in the prompt (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results).
The document rather states that non-clinical tests were performed to evaluate the device's performance and establish substantial equivalence to the predicate device, but it does not provide the specific numerical acceptance criteria or the precise results obtained from those tests in a table format. It broadly states that "The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the ground truth, sample sizes, expert qualifications, or adjudication methods for a study proving the device meets acceptance criteria, as this information is not present in the provided text.
Based on the available text, here is what can be extracted regarding the types of tests performed to demonstrate performance for substantial equivalence:
Types of Non-Clinical Tests Performed (Not acceptance criteria or performance numbers):
- Sterilization Validation:
- For sterile devices (fixtures): In accordance with ISO 11137, ISO 11737-1 & ISO 11737-2 for gamma sterilization.
- For non-sterile devices (abutments): In accordance with ANSI/AAMI ST79 for steam sterilization.
- Surface Characteristics Test:
- Chemical and SEM image analyses to verify no residual after RBM treatment on fixtures.
- Comparative Fatigue Testing:
- Performed in accordance with ISO 14801:2007.
- Biocompatibility Testing:
- Cytotoxicity Test: Performed according to ISO 10993-5:2009.
- Sensitization Test: Performed according to ISO 10993-10:2010.
The document concludes that "Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." However, no specific numerical acceptance criteria or quantitative performance data are presented in the document itself.
§ 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.