(602 days)
The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth. It is intended for delayed loading.
The Syntec Dental Implant provides Titanium Alloy (commercially followed by ASTM F136) 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 consists of implant, cover screw, healing abutment screw and abutments. The Syntec Dental Implant is for one and two stage surgical procedures. Its materials, dimensions, and intended use are similar to devices currently marked worldwide. The range of implant in diameter is from 3.4mm to 4.8mm and in length from 8.0mm to 14.0mm. The range of abutment in diameter is from 4.5mm to 6.5mm, and in length from 5.5mm to 12.0mm.
The Syntec Dental Implant K111189 510(k) summary does not contain information on an AI/ML device.
Here's a breakdown of the provided information, specifically addressing the criteria you've outlined, even though it's for a traditional medical device (dental implant):
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a traditional dental implant and not an AI/ML device, the acceptance criteria are based on mechanical properties, biocompatibility, and sterilization, rather than performance metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various bench tests conforming to international standards.
| Testing Item | Standard and Regulations Applied | Reported Device Performance (Implied Acceptance) |
|---|---|---|
| Static Strength | ISO 14801 | "Substantially equivalent to predicate devices" (result of biomechanical testing) |
| Fatigue Testing | ISO 14801 | "Substantially equivalent to predicate devices" (result of biomechanical testing) |
| Biocompatibility (Raw Material) | ISO-10993 | "Certificate of Raw material" submitted, implying compliance. |
| Sterilization (Gamma Irradiation) | ISO 11137 | "Sterilization Validation of Gamma Irradiation" submitted, implying compliance. |
| Sterilization (Moist Heat) | ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2 | "Sterilization Validation of Moist Heat" and "Sterilization Process Validation" submitted, implying compliance. |
| Surface Analysis (Morphology) | SEM | Data submitted, implying acceptable morphology. |
| Surface Analysis (Coating Thickness) | EN ISO 4288 | Data submitted, implying acceptable coating thickness. |
| Surface Analysis (Ca/P ratio) | EN ISO 11885-E22 | Data submitted, implying acceptable Ca/P ratio. |
| Surface Analysis (Residue) | ASTM F1854/ DIN EN ISO 4288 | Data submitted, implying acceptable residue levels. |
| Cytotoxicity | DIN EN ISO 10993-5 | Data submitted, implying acceptable cytotoxicity. |
| Solubility | FDA guidance (2/21/97) | Data submitted, implying acceptable solubility. |
| Analysis of Raw Material | ASTM F1185 and ASTM F1609 | Data submitted, implying compliance with material specifications. |
| Adhesive Tensile Strength | ASTM F-1147 | Data submitted, implying acceptable adhesive tensile strength. |
| Shear Strength | ASTM F-1044 | Data submitted, implying acceptable shear strength. |
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 510(k) summary. For bench testing of physical devices, "sample size" typically refers to the number of units tested per experiment, which is not detailed here. The studies are bench tests, not clinical studies with human participants. Data provenance is implied to be from the internal testing of Syntec Scientific Corporation in Taiwan.
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 is not applicable to a traditional dental implant submission. "Ground truth" in this context would be defined by the physical characteristics and performance measured against the standards, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a traditional dental implant submission based on bench 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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
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 consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the international standards and regulations (e.g., ISO 14801, ISO-10993, ISO 11137, etc.) referenced in the bench testing section. The device's physical and mechanical properties are measured and compared directly to the requirements outlined in these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.