(87 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 on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
This implant is not intended, nor should it be used, in conjunction with an angled abutment.
The NSI Implant System is intended 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 on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
This implant is not intended, nor should it be used, in conjunction with an angled abutment.
The provided text is a 510(k) Premarket Notification Summary for an Endosseous Dental Implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC studies) are not applicable in this context. The document explicitly states that "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."
However, I can extract information related to what was conducted and what the overall conclusion implies regarding its "acceptance."
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implicit): Substantial equivalence to predicate devices, ensuring no new issues of safety or effectiveness are raised by technological characteristics. | "The NSI Hexed and Non-Hexed Implant System has the same intended use as, and comparable technological characteristics to, legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness." |
| Material Standards (Explicit): Materials in the NSI Hexed Implant System meet applicable voluntary standards. | "Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium." |
| Fatigue Testing (Explicit): Testing conducted per FDA Class II Special Controls Guidance Document for Root-Form Endosseous Dental Implants. | "Fatigue Testing was conducted per FDA Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments that was issued on May 12, 2004. Modifications to the testing protocol were discussed with the FDA prior to conducting the test." |
| Torsion Testing (Explicit): Torsion testing was conducted. | "Torsion was also conducted (Enclosure 10)." (No specific performance values mentioned in this summary excerpt, but the fact it was done implies it met internal or regulatory expectations). |
| Technological Characteristics Comparability (Explicit): Physical properties and designs of new implants/accessories comparable to legally marketed predicate devices. | "The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A: Clinical studies were not conducted. The "test set" for this submission primarily consisted of the engineering tests (fatigue and torsion) performed on the new device iterations. The sample size for these engineering tests is not specified in this summary. Data provenance is not applicable as there are no human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A: Clinical studies were not conducted, so there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission. For the engineering tests, the "ground truth" is established by the accepted standards and protocols for mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No clinical studies were performed requiring adjudication of results from human subjects.
5. 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
- N/A: This is for an endosseous dental implant, not an AI-powered diagnostic device. No comparative effectiveness studies involving human readers or AI assistance were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the substantive equivalence claim: The "ground truth" is the established safety and effectiveness of the predicate devices and the accepted engineering standards (ASTM F67-95, FDA Class II Special Controls Guidance Document) for material and mechanical performance.
- For engineering studies: The "ground truth" is defined by the passing criteria of the specific fatigue and torsion tests, derived from the FDA guidance and discussions with the FDA.
8. The sample size for the training set
- N/A: No clinical studies were conducted, and this is not a machine learning device that requires a "training set."
9. How the ground truth for the training set was established
- N/A: No clinical studies were conducted, and this is not a machine learning device.
§ 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.