(210 days)
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The NSI Implant System is intended for implantation in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multipleunit implant restorations anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The provided 510(k) summary for the NSI Hexed and Non-Hexed Implant System (K033171) explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."
Therefore, based on the provided document, the following information cannot be determined:
- Acceptance criteria
- Reported device performance
- Sample size used for the test set
- Data provenance
- Number of experts used to establish ground truth
- Qualifications of experts
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study (effect size)
- Standalone performance study
- Type of ground truth used (for test set)
- Sample size for the training set
- How ground truth for the training set was established
The submission focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and expanding the intended use for immediate loading, rather than through clinical performance data.
§ 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.