(232 days)
The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
The AnyOne™ Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form endosseous dental implant. The AnyOne™ Internal Implant System contains three types of fixtures, normal thread type, and special length type. This system is made from CP4 Titanium and Ti-6A1-4V-ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration. This system has 3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm diameters for normal thread, 4.8, 5.8, 6.8, 7.8, 8.3mm diameters for deep thread, and 4.8, 5.3, 6.3, 7.3mm for special length fixtures. In addition, this system has 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for normal thread, 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for deep thread, and 7.0mm for special length fixtures.
Contained various abutments in the AnyOne™ Internal Implant System are straight and angled dental implant abutments intended to be connected to the fixture with screw, and to restore a patient's chewing function. The abutments contain Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling, Abutment, Zirconia Abutment, Gold Abutment, CCM Abutment, Temporary Abutment, Solid Abutment, Burn-out Cylinder, Octa Abutment, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Plastic Cylinder, Flat Abutment, Ball Abutment, Meg-Rhein, ZrGEN Abutment, Multi-unit Abutment, Fuse Abutment, Flat CCM Cylinder, Flat Cover Screw, Flat Healing Abutment, Flat EZ Post Cylinder, Flat Temporary Cylinder, Flat Plastic Cylinder, and Flat Gold Cylinder. The fixtures, prosthetics, and surgical instruments are produced, and packaged separately. All included devices in the system are covered by this submission.
The provided text describes the "AnyOne™ Internal Implant System" and its substantial equivalence to a predicate device, the "XPEED AnyRidge Internal Implant System (K122231)". However, it 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 document is a 510(k) summary for a traditional medical device (dental implants) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence, rather than quantitative performance metrics for an AI algorithm.
Here's an analysis based on the information provided, highlighting why it doesn't fit the requested AI/ML study format:
1. Table of Acceptance Criteria and Reported Device Performance
For this traditional medical device, the "acceptance criteria" are not reported as quantitative performance metrics (like accuracy, sensitivity, specificity for an AI model). Instead, the acceptance criteria for receiving 510(k) clearance are related to demonstrating substantial equivalence to a predicate device in terms of:
| Acceptance Criterion (for 510(k) Clearance) | Reported Subject Device Performance / Characteristics |
|---|---|
| Intended Use Equivalence | "The AnyOne™ Internal Implant System has a substantially equivalent intended use as the identified predicate." |
| Technological Characteristics Equivalence | "The AnyOne™ Internal Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium." |
| Specific similarities are listed: Materials (CP4 Titanium and Ti-6Al-4V-ELI), Sterilization (Gamma), Angulations of Angled abutments (15, 25°), Product Code (DZE, NHA), Surface treatment (SLA). Differences in specific fixture diameters and heights are present but deemed acceptable under the substantial equivalence pathway. | |
| Safety and Effectiveness | Implied through substantial equivalence to a legally marketed device and compliance with FDA's Class II special controls. "concludes that the AnyOne™ Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein." |
| Performance Standard Compliance (if applicable) | Non-Clinical Test Data: "The fatigue testing was performed in accordance with ISO 14801 standard." (This implies the device met the requirements of this standard for fatigue.) |
Regarding the specific questions related to AI/ML device studies:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a physical medical device (dental implant), not an AI/ML software. There is no "test set" in the context of an AI algorithm's performance evaluation. The "non-clinical test data" refers to mechanical fatigue testing, not a dataset of patient information.
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 expert ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication for algorithmic output is described.
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-assisted reading device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth in the context of AI/ML is not relevant here. The ground for device "performance" is compliance with mechanical standards (ISO 14801 for fatigue testing).
8. The sample size for the training set
- Not applicable. No training set for an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model.
Conclusion:
The provided document is a conventional 510(k) premarket notification summary for a dental implant system. It demonstrates substantial equivalence to a predicate device, focusing on intended use, technological characteristics, and material safety. It does not involve any artificial intelligence or machine learning components, and therefore, the requested information pertaining to AI/ML device acceptance criteria and studies (like test sets, ground truth, experts, and comparative effectiveness) is not present and not applicable to this submission. The only "test" mentioned is non-clinical fatigue testing to an ISO standard.
§ 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.