(339 days)
BR SLA 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. BR SLA Type Implant System is for single and two-stage surgical procedures. It is intended for delayed loading.
The BR SLA Type Implant System is a dental implant system made 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 implants 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 implants has been treated with S.L.A.
This document is a 510(k) premarket notification for a medical device called the "BR SLA Type Implant System." It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe a study evaluating the performance of an AI/ML device in meeting acceptance criteria. Instead, it focuses on the equivalence of a dental implant system.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI device. The document is about a conventional medical device (dental implant).
Here's what the document does provide regarding the non-clinical testing performed for the BR SLA Type Implant System, which serves as evidence for its substantial equivalence:
The non-clinical testing included:
- Sterilization validation testing: For sterile devices (fixtures) in accordance with ISO 11137, ISO 11737-1 & ISO 11737-2 for gamma sterilization.
- Steam sterilization validation: For non-sterile devices (abutments) in accordance with ISO 17665-1 and 17665-2.
- Surface characteristics test report: Chemical and SEM image analysis performed to verify no residual after SLA treatment on the fixtures.
- Cytotoxicity test: Performed according to ISO 10993-5:2009.
- Sensitization test: Performed according to ISO 10993-10:2010.
- LAL Endotoxin lot release testing: According to USP .
- Shelf life testing: Performed according to ISO 11607.
- Fatigue testing: Leveraged from the predicate device.
The document states that "The result of the above tests has met the criteria of the standard and proved the substantial equivalence with the predicate device." This indicates that the various tests performed (as listed above) served as the acceptance criteria for demonstrating that the device is substantially equivalent to existing predicate devices. The study proving the device meets these criteria is the culmination of these non-clinical tests.
No information is provided about:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample sizes used for a test set or data provenance (as this is not an AI/ML study).
- Number of experts or their qualifications for ground truth (as this is not an AI/ML clinical study).
- Adjudication method (not applicable for this type of device submission).
- Multi-reader multi-case (MRMC) comparative effectiveness study (not applicable).
- Standalone (algorithm only) performance (not applicable).
- Type of ground truth used (not applicable to the non-clinical tests described).
- Sample size for the training set (not applicable).
- How ground truth for the training set was established (not applicable).
§ 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.