(54 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 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 text describes a 510(k) premarket notification for the KOG1169 Endosseous Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on establishing performance criteria through clinical studies.
Therefore, many of the requested details about acceptance criteria, specific device performance, clinical study design, and ground truth establishment are not applicable or available in this document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (N/A): This submission is for an Endosseous Dental Implant System, and the document explicitly states, "FDA has not established a performance standard applicable to endosseous implants and their accessories." The submission relies on demonstrating substantial equivalence to predicate devices and meeting applicable voluntary standards for materials (ASTM F67-95 Grade III or Grade IV Titanium), sterilization, and packaging. The document does not provide specific quantitative performance metrics beyond these material and process standards.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable (N/A): No test set, in the context of an AI/algorithm performance study, was used or described. The submission is for a physical medical device (dental implant).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable (N/A): As no test set for an AI/algorithm was used, no ground truth experts were involved in this context.
4. Adjudication Method for the Test Set
Not Applicable (N/A): No adjudication method was involved as this is not an AI/algorithm performance study.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not Applicable (N/A): No MRMC study was conducted. The device is a physical dental implant, not an AI-assisted diagnostic tool. The document explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."
6. Standalone (Algorithm Only) Performance Study
Not Applicable (N/A): No standalone algorithm performance study was done as the device is a physical dental implant.
7. Type of Ground Truth Used
Not Applicable (N/A): As this is a submission for a physical device, not an AI/algorithm, the concept of "ground truth" in the context of diagnostic accuracy is not directly relevant. The assessment of the device's characteristics relies on compliance with material specifications (ASTM F67-95 Grade III or Grade IV Titanium) and validated sterilization and packaging methods (ISO, ASTM, EN standards).
8. Sample Size for the Training Set
Not Applicable (N/A): No training set was used as this is not an AI/algorithm submission.
9. How the Ground Truth for the Training Set Was Established
Not Applicable (N/A): No training set was used or ground truth established in this context.
Summary of Acceptance Criteria and Study:
Instead of typical AI/algorithm acceptance criteria and studies, this 510(k) submission demonstrates compliance by meeting material, sterilization, and packaging standards and demonstrating substantial equivalence to existing predicate devices.
Acceptance Criteria (based on compliance requirements):
| Criterion | Reported Device Performance/Compliance Summary |
|---|---|
| Material Composition | Meets ASTM F67-95 Grade III or Grade IV Titanium. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. |
| Sterility Assurance Level (SAL) | Achieves SAL of 10-6. Sterilization using Co60 irradiation with a minimum dose of 25.0 kGy (2.5 m rads) is validated as specified by AAMI and ISO 11137, ISO 11737-2, and ISO 13409. |
| Packaging Integrity & Performance | Validated to ASTM and EN standards. Packaging is validated following ASTM D 4169-04, ASTM F 88-00, ASTM F 1929-98, EN 552, EN556-1:1997, EN 868-1:1997, EN 868-5:1999, EN 868-9:2000, EN 868-10:2000, and ISO 11607. |
| Technological Characteristics | Comparable to legally marketed predicate devices. "The physical properties and designs of the additional implants and accessories in the NSI Endosseous Dental Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable." |
| Safety and Effectiveness (overall) | No new issues of safety or effectiveness raised compared to predicates. "Any differences in the technological characteristics did not raise new issues of safety or effectiveness." The FDA's substantial equivalence determination implies it meets general controls of the Act. |
Study Proving Acceptance Criteria:
The "study" or justification for meeting acceptance criteria in this 510(k) involves:
- Conformance to Voluntary Standards: Explicitly stating that materials meet ASTM standards and sterilization/packaging processes are validated according to a comprehensive set of ISO, AAMI, ASTM, and EN standards.
- Predicate Device Comparison: A direct comparison of the technological characteristics and intended use of the new implants and accessories with a list of previously cleared predicate devices (K003620, K020617, K033171, K052490, K053478 NSI systems, and several Straumann Implant Systems K894595, K955281, K012757, K013798, K990342, K962023). The conclusion drawn is that the new components are substantially equivalent.
- Declaration of No Clinical Studies Needed: The submission explicitly states, "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission," indicating that the justification for safety and effectiveness is based on the substantial equivalence argument and adherence to recognized standards, rather than new clinical 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.