(204 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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The NSI MAX Implant System is intended for implantation in the maxilla or mandibular molar region where bone exists and the surgeon has determined a wider implant would increase the probability of placement of a narrow implant, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It also adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The provided document is a 510(k) premarket notification for an Endosseous Dental Implant System. It does not describe acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria.
Instead, this document focuses on demonstrating substantial equivalence of a dental implant system to previously marketed predicate devices. Key aspects covered are:
- Device Description and Intended Use: The NSI Implant System for supporting dental prostheses in the upper or lower jaw, with an option for immediate loading.
- Performance Standards: There is no FDA performance standard for endosseous implants. The materials used meet applicable voluntary standards (ASTM F67-95 Grade III or IV Titanium).
- Sterilization Methods: Achieved using Co60 irradiation, validated against ISO 11137, ISO 11737-2, and ISO 13409.
- Packaging Method and Validation: Packaging involves plastic tubing, blister packs, and clear plastic boxes, validated against various ASTM, EN, and ISO standards related to performance testing, seal strength, leak detection, accelerated aging, and general requirements for sterile medical device packaging.
- Technological Characteristics: Compared with predicate devices and found to be comparable.
- Surface Modifications: Blasted with 100 micron alumina particles, with visual inspection and SEM testing.
- Clinical Studies: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This explicitly states that no clinical performance study was performed or considered necessary to establish substantial equivalence for this particular submission.
Therefore, since the request is about an AI-powered device and the provided document describes a physical medical device (dental implant) and explicitly states no clinical studies were conducted, I cannot provide the requested information about acceptance criteria and a study proving an AI device's performance based on this document.
The document does not contain any information about:
- Acceptance criteria for an AI device.
- Reported device performance for an AI device.
- Sample size for a test set or data provenance for an AI device.
- Number of experts or their qualifications for establishing ground truth for an AI device.
- Adjudication methods for an AI device's test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone AI algorithm performance.
- Type of ground truth used for AI.
- Sample size or ground truth establishment for a training set for AI.
§ 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.