(86 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 4.0 co-axis implant is not intended, nor should it be used, in conjunction with an angled abutment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Endosseous Dental Implant System (K070841).
It's important to note that this document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly proving performance against pre-defined acceptance criteria through a clinical trial. Therefore, the "acceptance criteria" here are generally related to compliance with standards and demonstration of comparable performance to predicate devices, rather than specific sensitivity/specificity metrics.
Acceptance Criteria and Reported Device Performance
The submission relies on demonstrating substantial equivalence to previously cleared predicate devices and adherence to relevant standards for manufacturing, sterilization, and packaging. There are no explicit performance metrics in the format of sensitivity, specificity, accuracy, etc., as would be found for a diagnostic device.
| Acceptance Criterion Type | Standard/Guidance | Reported Device Performance |
|---|---|---|
| Material Composition | ASTM F67-95 Grade III or Grade IV Titanium | Compliant: Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. |
| Sterilization Efficacy | ISO 11737, ISO 11737-2, ISO 13409 | Compliant: Sterilization will be achieved using Co60 irradiation with a minimum dose of 25.0 kGy (2.5 mrads), creating a Sterility Assurance Level of 10⁻⁶. Validation done as per AAMI. |
| Packaging Integrity | ASTM D 4169-04, ASTM F 88-00, ASTM F 1929-98, EN 552, EN 556-1:1997, EN 868-1:1997, EN 868-5:1999, EN 868-9: 2000, EN 868-10:2000, ISO 11607 | Compliant: All Southern Implants packaging is validated following these standards. |
| Mechanical Stability (Fatigue) | FDA Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments (May 12, 2004) | Compliant: Fatigue testing conducted per the guidance document. Testing revealed a stable screw joint at the highest forces tested. |
| Surface Modification (Biocompatibility/Adhesion) | Not a specific standard, but addresses potential concern | Compliant: Surface blasted with 100 micron alumina (Al₂O₃) particles (biocompatible). Relatively low pressure blasting to reduce embedment. Surface roughness (Sᵣ) of 1.43 microns (fraction of particle size). Each implant visually inspected; sample SEM testing quarterly. |
| Technological Characteristics | Comparison to predicate devices | Compliant: Physical properties and designs of additional implants and accessories were comparable to legally marketed predicate devices. "Any differences in the technological characteristics did not raise new issues of safety or effectiveness." |
| Intended Use | Same as predicate devices | Compliant: Same intended use as predicate devices, with added option for immediate loading under specific conditions. |
Study Details
This 510(k) submission states explicitly that clinical studies were not conducted or deemed necessary. The "study" here refers primarily to engineering bench tests and comparisons to predicate devices and standards.
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Sample size used for the test set and the data provenance:
- Test Set (Engineering Studies): The document mentions "sample implant is sent for SEM testing four times a year" for surface evaluation. For fatigue testing, it states "Modification to the testing protocol was discussed with the FDA prior to conducting the test (Enclosure 8 Appendix B). Testing revealed a stable screw joint at the highest forces tested (Enclosure 8)." The exact number of implants tested for fatigue is not specified in the provided text, but it implies a representative sample.
- Data Provenance: The engineering studies (fatigue, surface analysis) were conducted internally or by a contracted lab as part of the manufacturing and submission process. The submission does not specify a country of origin beyond the submitter's address (Fairfax, VA, USA). The studies are by nature prospective as they are conducted for the specific purpose of this submission or as part of ongoing quality control.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense. For engineering tests like fatigue, the "ground truth" is the established pass/fail criteria of the test method itself, which is based on an FDA guidance document. For material composition and sterilization, the ground truth is adherence to the specified ASTM/ISO/EN standards.
- Visual Inspection/SEM: Manufacturing protocol includes visual inspection by trained personnel, and SEM testing is conducted by qualified lab personnel.
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Adjudication method for the test set:
- Not applicable as this is not a study requiring human reader consensus for "ground truth". The "adjudication" is compliance with engineering and quality standards.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study is not relevant for an endosseous dental implant system, as it is not an imaging or diagnostic AI device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's evaluation is primarily compliance with established engineering standards (ASTM, ISO, EN), FDA guidance documents for mechanical testing, and material specifications. For surface characteristics, it involves direct physical measurement and visual/SEM verification against internal specifications and biocompatibility principles.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.
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How the ground truth for the training set was established:
- Not applicable. See above.
§ 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.