(204 days)
Anker Dental Implant System 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, and to restore the patient's chewing function. It is intended for delayed loading.
Anker Dental Implant System consists of fixture, abutment (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment) and cover screw. Fixture is made of pure titanium (grade IV) and its surface was treated by SLA (Sand-blasted, Large grit, Acid-etched) process. Diameters of fixtures are including 3.4 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Most abutments are made of titanium alloy and their diameters are including 4.0 to 7.0 mm. Temporary abutment is made of SUS316 stainless steel instead of titanium alloy. All products are sterilized as finished products.
The Anker Dental Implant System is a medical device and its acceptance criteria are based on non-clinical testing to demonstrate substantial equivalence to predicate devices. No clinical study or human-in-the-loop performance study has been conducted for this device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Testing Item | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| Compressive forces and Fatigue tests | ISO14801 | Met ISO14801 standards (implied by "support the decision of safety and effectiveness" and "results...demonstrate...substantially equivalent") |
| Compatibility test of dental implant/abutment | ||
| interface | N/A (No specific reference provided, but likely industry standards) | Met compatibility requirements (implied by "support the decision of safety and effectiveness") |
| Corrosion test | ASTM G3-89 | Met ASTM G3-89 standards (implied by "support the decision of safety and effectiveness") |
| Residual of Acidic Substances Test | ISO10993-12 | Met ISO10993-12 standards (implied by "support the decision of safety and effectiveness") |
| Biocompatibility test | ISO10993-3, ISO10993-5, ISO10993-6, ISO10993-10, ISO10993-11, Pharmacopeia US, OECD guideline #473, OECD guideline #474 | Met all listed biocompatibility standards (implied by "support the decision of safety and effectiveness") |
| Sterilization Validation of Gamma Irradiation | ISO11137-1 | Met ISO11137-1 standards (implied by "support the decision of safety and effectiveness") |
| Shelf life Validation | ASTM F88/F88M-09, ASTM F1140-07, ASTM F1929-98, ISO11737-2 | Met all listed shelf life validation standards (implied by "support the decision of safety and effectiveness") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The text states that "Non-clinical test was used to support the decision of safety and effectiveness," but does not specify sample sizes for these tests or the data provenance. These are laboratory/benchtop tests, not human subject studies.
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)
This information is not applicable as the acceptance criteria were established through non-clinical laboratory testing, not human expert evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the acceptance criteria were established through non-clinical laboratory testing.
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
No, an MRMC comparative effectiveness study was not conducted. The document explicitly states "Non-clinical test was used to support the decision of safety and effectiveness" and "Clinical Testing: Non-clinical test was used to support the decision of safety and effectiveness," indicating that no clinical studies with human participants were performed. This device is not an AI-assisted diagnostic tool, so comparison with human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done as this device is a physical dental implant system, not a software algorithm. The "standalone" concept applies to AI/software performance in isolation, which is not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests was based on internationally recognized testing standards (e.g., ISO, ASTM, OECD guidelines). The device's performance was compared against the requirements and specifications outlined in these standards.
8. The sample size for the training set
This information is not applicable as there was no training set for an algorithm. The evidence presented is for a physical medical device and its material and mechanical properties.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for an algorithm.
§ 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.