(118 days)
The intended purpose of the AbsoAnchor microimplant is to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
The Dentos AbsoAnchor Orthodontic Microimplant is composed of Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136) material. It has been designed specifically for orthodontic use and has a button-like head and a bracket-like head with a small hole that accepts ligatures, coil springs, and elastomers. Gingival impingement by these attachments is reduced due to the slanted neck of the implant head. The smaller diameter of AbsoAnchor (1.2mm - 1.8mm) allows its insertion into many areas of the maxilla and mandible and between roots of adjacent teeth. It is classified into 2 implant groups: Taper and Cylinder. It also consists of 8 different head styles: small head, no head, long head, circle head, fixation head, bracket head, bracket head-left handed screw, OMAS mushroom.
The provided text is a 510(k) summary for the Dentos AbsoAnchor Orthodontic Microimplant. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel AI device might.
Therefore, for aspects related to AI/algorithm performance, ground truth establishment, expert adjudication, and comparative effectiveness with human readers (which are typical for AI-powered medical devices), the information is not applicable or not provided in this type of submission.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are implicitly derived from demonstrating substantial equivalence to its predicate devices, rather than through quantitatively defined performance metrics (e.g., sensitivity, specificity) against a gold standard for a specific diagnostic task. The "performance" is primarily shown through direct comparison of material, intended use, and physical characteristics.
| Acceptance Criterion (Implicitly Derived from Predicate Comparison) | Reported Device Performance (AbsoAnchor) |
|---|---|
| Material Composition | Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136) |
| Intended Use | Provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth |
| Product Code | DZE |
| Sterility | Non-sterile: steam sterilize before use |
| Diameter Range | 1.2mm-1.8mm |
| Length Range | 4.0mm-10mm & 12mm |
The study that "proves" the device meets these acceptance criteria is the 510(k) premarket notification process itself, where the manufacturer demonstrates substantial equivalence to predicate devices. This is achieved by comparing various specifications and intended uses, as summarized in the table above. The conclusion of substantial equivalence by the FDA (as stated in the letter) indicates that these implicit criteria have been met.
Additional Information:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This type of 510(k) submission for a physical implantable device does not typically involve a "test set" or "data provenance" in the context of an AI/algorithm study. The evaluation relies on material science, mechanical testing, and comparison of design features to legally marketed devices.
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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 applicable / Not provided. Ground truth establishment for a diagnostic AI algorithm is not relevant for this device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods for ground truth are not relevant for this device.
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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:
- No. This is a physical orthodontic microimplant, not an AI-assisted diagnostic tool. Therefore, an MRMC study and
effect size related to AI assistance are not applicable.
- No. This is a physical orthodontic microimplant, not an AI-assisted diagnostic tool. Therefore, an MRMC study and
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" would relate to the material properties, manufacturing quality, and biocompatibility of the implant, as well as its functional similarity to predicate devices. These are evaluated through bench testing (e.g., mechanical strength, biocompatibility tests), adherence to ASTM standards (e.g., ASTM F136 for the material), and clinical experience with similar devices, rather than expert consensus on diagnostic images or pathology. The submission relies on such technical data and comparisons to establish safety and effectiveness.
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The sample size for the training set:
- Not applicable / Not provided. A "training set" is relevant for machine learning algorithms, not for physical medical implants in a 510(k) submission.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not applicable.
§ 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.