(84 days)
AEDIS ™ provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture installations in partially or fully edentulous mandibles and maxillae.
Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.
The device is a Titanium alloy, root form implant system consisting of: a self-tapping 1.8 mm diameter implant screw with an integrated hexagonal fitment for attachment of an abutment, and a cap screw designed to lock the abutment to the implant screw. AEDIS™ abutments are not angled.
AEDIS ™ follows natural tooth morphology and is recommended for use in mandibular and maxillary anterior locations for restoration applications. The screw diameter is 1.8mm and is offered in lengths of 13.5 and 15mm. A minimally invasive procedure allows for immediate placement, and temporization in single and multiple tooth restorations. The implant screws are self tapping.
A titanium abutment is provided and is intended to be mechanically affixed to the screw to hold a crown, bridge, or other prosthetic appliance. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw. The abutment is cone shaped; 8 mm in height; has a hexagonal fitment to provide for the cap screw) to lock the abutment the implant screw. The 5 mm diameter of the base of the abutment is identical to the diameter of the top of the implant screw. When all elements of the system are attached to each other the tolerances between the parts are 3 microns or less.
Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.
AEDIS™ is offered in a kit including: implant components; surgical instruments; a tissue punch, leveling bit, and implant insertion instruments. The package also includes recommended surgical protocols, and illustration of recommended insertion techniques. The kit is packaged in a plastic container with appropriate labeling. The AEDIS ™ is delivered in sterile condition, however many practitioners also autoclave the device in their own Operatories.
The provided text describes a 510(k) summary for the AEDIS™ (Adams Embed Dental Implant System), a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone clinical study of the new device.
Therefore, the document does not contain information typically found in a study proving a device meets specific performance acceptance criteria, especially for AI/software-as-a-medical-device (SaMD) where metrics like sensitivity, specificity, or reader improvement are common.
Here's an analysis based on the provided text, highlighting what is present and what is not:
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A table of acceptance criteria and the reported device performance
- Not present. This document discusses substantial equivalence to a predicate device, not performance against specific, predefined acceptance criteria with numerical results. It states, "EMBED has provided test results and related scientific data demonstrating the substantial equivalence of the IMTEC predicate device and AEDIS™." However, the results themselves or specific performance metrics are not detailed. The table provided in the document focuses on technological characteristics for comparison, not performance.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No test set size, data provenance, or study design (retrospective/prospective) is described. The document indicates that "tests were performed at an independent, highly qualified laboratory," but does not provide details about these tests.
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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 present. Since no specific test set or ground truth establishment is described, this information is not available.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No adjudication method is mentioned as there's no description of a study involving expert review for a test set.
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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 present. This document describes a dental implant, which is a physical device, not an AI or software product. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. As mentioned, this is a physical dental implant, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not present. There is no mention of a ground truth in the context of a performance study for the AEDIS™. The "ground truth" for a 510(k) is typically the predicate device's established safety and effectiveness.
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The sample size for the training set
- Not present. Training sets are relevant for machine learning or AI models, which this device is not.
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How the ground truth for the training set was established
- Not present. See point 8.
Summary of what is available from the text regarding the "study":
The "study" referenced in this document is not a clinical performance study with predefined acceptance criteria for the AEDIS™ itself. Instead, it is a substantial equivalence comparison to a predicate device (Imtec 1.8 mm diameter implant K031106 and others).
- Acceptance Criteria for 510(k): The overarching "acceptance criterion" for a 510(k) submission is demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the differences do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate.
- Device Performance (as reported for the 510(k)): The document states: "EMBED has provided test results and related scientific data demonstrating the substantial equivalence of the IMTEC predicate device and AEDIS™." It further notes: "The tests were performed at an independent, highly qualified laboratory who certified the accuracy of the test results."
- Technological Characteristics Comparison (instead of performance table): The document provides a comparison table of technological characteristics:
| Device Name | AEDIS™ | IMTEC 1.8 MDI implant |
|---|---|---|
| Product Code | DZE | DZE |
| 510(k) | K 100902 | K031106 |
| Material | Titanium Alloy | Titanium Alloy |
| Biocompatibility | Biocompatible | Biocompatible |
| Sterility | Sterile | Sterile |
| Intended use | Self tapping titanium threaded screws indicated for long term intra-intrabony applications. Additionally MDI may also be used for intra-radicular transitional application | Same as AEDIS™ |
In conclusion, the provided text details a 510(k) submission focused on demonstrating substantial equivalence of a physical medical device (dental implant) to a predicate device, rather than a performance study meeting specific, quantified acceptance criteria typically seen for new, innovative technologies or AI/SaMD products. Therefore, most of the requested information (sample sizes, expert qualifications, ground truth methods, MRMC studies) is not applicable or not present in this type of regulatory document.
§ 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.