(281 days)
ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.
Dental implant systems are devices made of a material such as titanium 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, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.
This 510(k) summary (K081748) for the ONEPLANT Dental Implant System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.
Instead, this submission is for a traditional medical device (dental implants) and focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means the manufacturer is showing that their new device is as safe and effective as devices already on the market, by comparing its materials, design, intended use, and functional characteristics.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. I will fill in what can be gleaned from the provided text, and explicitly state when information is not available or not relevant for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of an AI/ML device performance study. This submission is for a physical medical device (dental implants). The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices in terms of materials, design, and intended use. The "reported device performance" refers to the characteristics that allow it to be considered equivalent, rather than quantitative performance metrics from a clinical trial.
| Characteristic | Acceptance Criteria (Predicate Devices) | Reported Device Performance (ONEPLANT) |
|---|---|---|
| Intended Use | To provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function; for use in partially or fully edentulous mandibles and maxillae, to support single or multiple-unit restorations (cemented/screw-retained, overdenture, fixed bridgework). | Designed for use in dental implant surgery; intended for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations (cemented/screw-retained, overdenture, fixed bridgework). (Substantially equivalent) |
| Design | Internal Connection: Morse Taper, Internal Octagon | Internal Connection: Morse Taper, Internal Octagon (Substantially equivalent) |
| Fixture Material | Titanium G4 | Titanium G4 (Substantially equivalent) |
| Fixture Platform Dia. | 3.5-5.5mm (ranges from predicates) | 3.3, 3.6, 4.3, 5.3mm (Similar dimensions) |
| Fixture Length | 7-15mm (ranges from predicates) | 8.5, 10, 11.5, 13, 15mm (Similar dimensions) |
| Abutment Material | Titanium G5 | Titanium G5 (Substantially equivalent) |
| Abutment Type | Various | Various (Substantially equivalent) |
| Certification | KGMP, CE, FDA 510(k) (for predicates) | KGMP (for ONEPLANT) - This indicates they have some initial certification, and the 510(k) process is to obtain FDA clearance, hence the lack of "FDA 510k" listed before clearance. (Not an equivalence point for the 510(k) itself, but a regulatory status) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission does not involve a "test set" in the context of an AI/ML device or a clinical performance study with patient data. It is a comparison of product specifications and materials.
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)
Not applicable. No ground truth was established by experts from a test set. The comparison is based on the technical specifications of the devices themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set was used.
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 not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable as there is no "ground truth" derived from patient data or clinical outcomes in this substantial equivalence submission. The "ground truth" for the comparison is the established characteristics and performance of the predicate devices based on their prior clearances and regulatory compliance.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device; there is no training set or associated ground truth establishment.
Summary regarding K081748:
This 510(k) submission for the ONEPLANT Dental Implant System is a substantial equivalence submission for a traditional medical device (dental implants). It is not for an AI/ML device and therefore does not include or require the types of performance studies and data analyses that would be found in a submission for an AI/ML product. The "study" proving the device meets acceptance criteria is the comparison table demonstrating that the ONEPLANT system has similar design, materials, and intended use as the legally marketed predicate devices (DENTIUM and Osstem Implant systems). The conclusion explicitly states: "In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table 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.