(86 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.
The subject Neodent Implant System implants are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. The proposed CM Drive implants come in three diameters (3.5, 4.3 and 5.0 mm) and a length of 18.0 mm. They are made of commercially pure and acid etched surface finish or the Acqua grit blasted, acid etched and hydrophilic, chemically active surface finish.
The CM Drive implants (K123022) have been shown to be compatible with the previously cleared angled abutments (K101945) having the CM implant-to-abutment interface.
The addition of the 18mm lengths to the previously cleared CM Drive Implants has no detrimental impact on device indications or performance. All other attributes are identical. No modifications were made to the coronal features of the implant that would impact dynamic fatigue performance.
A groove has been added to the conic portion of six (6) CM Mini Conical Abutments to ensure that the abutments do not release from the transfer tool during transfer from the package until secured in the implant. This feature also assures secure retention of the abutment in the package during storage and shipment.
The pilot hole depth of the CM Abutments was reduced in order to increase the minimum wall thickness of the abutment. The length of the internally threaded portion of the abutment was not changed, so engagement between the occlusal screw and the abutment is also unchanged.
This document is a 510(k) Pre-market Notification for the Neodent Implant System. It primarily addresses the substantial equivalence of the new device to previously cleared predicate devices, rather than detailing a study with specific acceptance criteria for a novel AI/software device. As such, most of your requested information (related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.
However, I can extract information related to the performance data presented and the comparison to predicate devices, which serves a similar function to acceptance criteria in the context of a 510(k) submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k) for a dental implant system, "acceptance criteria" are implicitly defined by the demonstration of substantial equivalence to predicate devices. The primary performance criterion mentioned is dynamic fatigue testing, consistent with FDA guidance and ISO 14801. The "reported device performance" is that the device demonstrated substantial equivalence through these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K123022 & K133592) in terms of safety and effectiveness. | The subject devices (Neodent Implant System - CM Drive Implants with 18mm length) were shown to be substantially equivalent to predicate devices. |
| Compliance with dynamic fatigue test data requirements per FDA guidance and ISO 14801. | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices. |
| Load-bearing features of the implant-abutment connection demonstrate acceptable performance with angled prosthetic abutments (worst-case scenario). | Load-bearing features were tested, and results demonstrated substantial equivalence. |
| Risk analysis (FMEA) demonstrates that changes have no adverse impact on sterility, packaging, and biocompatibility. | FMEA was conducted and demonstrated applicability of predicate/reference device assessments to the subject devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of implants or tests performed for the dynamic fatigue testing. It generally states that "Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced." ISO 14801 typically involves mechanical testing of multiple samples, but the exact count is not given here.
- Data Provenance: The data is presented as "bench studies" performed by the manufacturer (JJGC Industria e Comercio de Materiais Dentarios SA or Instradent USA, Inc.). The country of origin of the data is not explicitly stated in terms of where the tests were physically conducted. The submission is from New Hampshire, USA on behalf of a Brazilian company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this medical device submission is based on engineering and material science standards (e.g., ISO 14801) and the performance of predicate devices, not on expert consensus or clinical outcomes from a test "set" in the way an AI algorithm test set would be adjudicated.
4. Adjudication method for the test set
This information is not applicable for a physical device's substantial equivalence review. Testing is based on pre-defined engineering standards.
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
This information is not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI/software device.
7. The type of ground truth used
The "ground truth" in this context is the mechanical performance standards (specifically dynamic fatigue strength as per ISO 14801) and the established safety and effectiveness profile of the legally marketed predicate devices. The new device's performance is compared against these engineering standards and the characteristics of the predicate devices.
8. The sample size for the training set
This information is not applicable. This is not an AI/software device. No training set is mentioned or implied.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/software device. No training set or ground truth establishment method for a training set is mentioned.
§ 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.