(121 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
- Intended for single use;
- Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium (Ti) grade 4 per ASTM F67;
- Morse Taper prosthetic interface with internal hexagonal indexer, exclusively from the Grand Morse (GM) line;
- Body center and apex with conical format;
- Trapezoidal-profile double threads;
- Rounded apex end;
- Available in Neoporos and Acqua surfaces;
- Ø7.0 mm and 8, 10, 11.5, and 13 mm lengths;
- The subject devices are compatible with all the abutments of the Neodent Implant System that present the GM implant to abutment interface, previously cleared per K163194, K173902, K180536, K191191, and K1922229.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Neodent Implant System - GM Helix Implants 7.0. It aims to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided text, the device is a dental implant. The concept of acceptance criteria and performance related to the AI/ML device is not applicable here. The document describes different types of testing for device safety and effectiveness.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
Please note that this document is for a medical device (dental implant), not an AI/ML device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical, biological, and sterilization aspects, not AI performance metrics like accuracy, sensitivity, or specificity.
| Test Category | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993 standards (e.g., ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-18). | Biological Safety Assessment guided by ISO 10993-1 performed. Cytotoxicity testing performed per ISO 10993-5. Chemical characterization performed per ISO 10993-18. Made of commercially pure titanium grade 4 (ASTM F67), same as predicate devices. The subject devices do not present a new worst case for biocompatibility; predicate device testing is relied upon. |
| Mechanical Testing | Equivalence to predicate devices in dynamic fatigue strength, as per ISO 14801 and FDA Guidance. | Dynamic fatigue test per ISO 14801 was performed. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices. Insertion torque testing was also performed. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6, validated by ISO 11137-1 and ISO 11137-2. Endotoxin limit of 20 EU/device. | Sterilized by gamma irradiation at a nominal dose of 25 kGy. Validation by VDma22 method, according to ISO 11137-1 and ISO 11137-2, achieved a SAL of 10^-6. Routine endotoxin testing performed monthly on representative samples with a test limit of 20 EU/device. |
| Shelf Life | Maintenance of sterile barrier after storage for the validated shelf life. | Validated for a shelf life of 5 years by accelerated aging according to ASTM F1980. Packaging validated according to ISO 11607-1 and ISTA 2A. Sealing strength (ASTM F88), Dye Penetration (ASTM F1929), and Bubble Test (ASTM F2096) were conducted to verify sterile barrier maintenance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each test mentioned (biocompatibility, mechanical testing, sterilization validation, shelf life validation). It refers to "representative samples" for endotoxin testing and indicates that tests were "performed" (e.g., dynamic fatigue test per ISO 14801). The "data provenance" is not explicitly stated in terms of country of origin or retrospective/prospective studies for these specific tests. However, the sponsor is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) located in Curitiba, Parana, Brazil. The regulatory contact is in Andover, Massachusetts, USA.
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)
This question is not applicable as the document describes a medical device, not an AI/ML diagnostic system requiring expert interpretation for ground truth establishment. The document relies on established international standards (ISO, ASTM, USP) and FDA guidance for evaluating the physical, chemical, and biological properties of the dental implant. Expert roles would be in the design, testing, and regulatory review processes, but not in establishing "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for AI/ML diagnostic studies where multiple readers interpret cases and their discrepancies are resolved. The document focuses on laboratory and material testing of a physical device.
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
Not applicable. This is a 510(k) submission for a physical medical device (dental implant), not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness analysis with human readers would have been performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This relates to AI/ML device performance. The described device is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of physical device, "ground truth" is established by adherence to recognized standards and validated test methods (e.g., ISO 10993 for biocompatibility, ISO 14801 for mechanical fatigue, ISO 11137 for sterilization) rather than expert consensus on diagnostic images or pathology. The "truth" is whether the device meets the physical and biological specifications under test conditions.
8. The sample size for the training set
Not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This document describes the validation of a physical medical device.
9. How the ground truth for the training set was established
Not applicable (as 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.