(253 days)
MBA Biotech 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, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.
The MBA Biotech Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of teeth. It is two stage endosseous screw type implant with internal hexagonal connection.
This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures.
The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.
The provided FDA 510(k) Clearance Letter for the MBA Biotech Implant System does not contain information related to a study proving the device meets acceptance criteria for an AI/ML medical device.
The document discusses the substantial equivalence of the MBA Biotech Implant System (a dental implant, a hardware device) to a predicate device, focusing on material, dimensions, surface treatment, sterilization, and non-clinical testing (fatigue, shelf-life, biocompatibility). It explicitly details how tests for the predicate device were leveraged for the subject device due to similar characteristics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone performance data for an algorithm.
- Type of ground truth used.
- Sample size for a training set.
- Ground truth establishment for a training set.
These points are relevant for the development and regulatory clearance of AI/ML-based medical devices, which are typically software devices. The MBA Biotech Implant System is a physical dental implant, and its clearance process relies on demonstrating substantial equivalence to existing physical devices through bench testing and material comparisons, not AI/ML performance studies.
§ 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.