(156 days)
Aria Bio's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.
The provided document describes a 510(k) premarket notification for Aria Bio's Dental Implant System, asserting its substantial equivalence to predicate devices. The document does not describe acceptance criteria for particular performance metrics nor does it present detailed study results proving a device meets specific acceptance criteria in the format requested.
Instead, the document focuses on demonstrating substantial equivalence through:
- Comparison of indications for use and technological characteristics with predicate devices.
- Reporting that a series of performance tests (fatigue, surface analysis, biocompatibility, sterilization, shelf life) were performed and that "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency." However, it does not provide the specific acceptance criteria for these tests, nor the detailed results.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details regarding sample sizes for training/test sets, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided text.
The document states:
- "A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life."
- "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency."
This indicates that these tests were conducted, and their outcomes were deemed acceptable based on established industry standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). However, the specific quantitative acceptance criteria or the actual performance results (e.g., specific fatigue limits, exact sterilization validation parameters, detailed surface analysis findings) are not provided in the document beyond stating that they were performed and supported substantial equivalence.
Without these specific details, I cannot construct the requested table or answer most of the specific questions about the study design and results.
§ 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.