(221 days)
IR 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. IR Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR Implant System is intended only for straight placement with no correction of angulation.
IR Type Implant System is a dental implant system made of of CP Ti Gr. 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).
I am sorry, but the provided text does not contain information about acceptance criteria and the study that proves a device meets those criteria. The document discusses regulatory approval for a dental implant system (IR Type Implant System) based on its substantial equivalence to a predicate device.
Specifically, it mentions:
- Acceptance Criteria/Performance Data: The document states that "The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device." However, it does not specify what those criteria were (e.g., specific thresholds for a given metric) nor does it provide the reported device performance against those criteria in a table format as requested. The tests mentioned are non-clinical (sterilization, surface characteristics, cytotoxicity, sensitization, LAL Endotoxin, shelf life), which are standard for medical devices but not directly related to a diagnostic performance study with a test set of data.
- Sample size and data provenance: Not applicable as no diagnostic performance study on a test set is described.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Training set sample size and ground truth establishment: Not applicable.
The document's focus is on demonstrating substantial equivalence for regulatory clearance (510(k)), primarily through comparison with a predicate device and non-clinical engineering/materials testing, rather than a clinical performance study involving a test set of data and human readers in the context of AI or diagnostic performance.
§ 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.