(90 days)
The NT/IT System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The NT/IT System is for one and two stage surgical procedures. It is not for immediate load.
The NT/T System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The NT/IT System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The NT/IT System is substantially equivalent in design, function and intended use to the SS System(K062051), GS System(K063861) and US/SS/GS System(K073247) of Osstem Implant Co., Ltd., NobelEsthetics (K072570) of NobelBiocare USA LLC and SynOcta Prosthetic System(K073628) and Solid Abutment Prosthetic System(K080286) of STRAUMANN USA LLC
The provided text describes an FDA 510(k) premarket notification for a dental implant system called the "NT/IT System." This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from the provided text. The document's purpose is to demonstrate that the new device is "substantially equivalent" to existing, legally marketed devices, implying that its safety and effectiveness are understood to be similar based on its shared characteristics with those predicates.
Here's an analysis of what can be gleaned, and where the information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "review" section mentions safety tests including biocompatibility to ensure compliance with "applicable International and US regulations," but no specific numerical criteria are given.
- Reported Device Performance: Not provided numerically. The document states, "The NT/IT System has been subjected to safety, performance, and product validations prior to release." However, the results of these validations are not detailed. Instead, the conclusion is: "Osstem concludes that the NT/IT System is safe and effective and substantially equivalent to the predicate device as described herein."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
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)
- Ground Truth Experts: Not applicable/not mentioned. This type of detailed study is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not mentioned.
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
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This document pertains to a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable/not mentioned. Again, this is for a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The document implies that the "ground truth" for the device's safety and effectiveness is established by its similarity to predicate devices that have already demonstrated safety and effectiveness through their regulatory history and clinical use. There is no mention of a specific ground truth dataset like pathology or outcomes data for this specific premarket notification.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not mentioned. This document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable/not mentioned.
Summary of what the document does provide regarding the device's validation:
- Device Name: NT/IT System
- Intended Use: For use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. For one and two-stage surgical procedures (not for immediate load).
- Safety & Performance Statement: "The NT/IT System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (However, no specific data or acceptance criteria for these validations are provided in the summary.)
- Conclusion: The device is "safe and effective and substantially equivalent to the predicate device."
- Predicate Devices:
In essence, this 510(k) summary asserts equivalence to established devices based on material, indication for use, design, and technological characteristics, rather than presenting a detailed study with explicit acceptance criteria and performance data for the NT/IT System itself.
§ 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.