(264 days)
"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.
The Chang Gung "ComMed" Series Dental Implant System includes threaded root-form endosseous dental implants (fixtures) and dental implant abutments (healing abutment, standard abutment, angle abutment). The implants are cylindrical and tapered posts made of Grade 4 Pure Titanium. The abutments are made of Ti6Al4V. The system features an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. Various diameters (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm) and lengths (10, 11, 12, 13, 14, 15, 16 mm) are available for the implants. The surface treatment is blasted with Aluminum Oxide and Acid Etched, and it is also anodized. Implants are sterilized by Gamma irradiation, and abutments are sterilized by moist heat sterilization before use by clinicians.
The provided text describes the Chang Gung "ComMed" Series Dental Implant System and its clearance through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as existing ones, rather than providing extensive de novo clinical trials typical for novel medical devices. Therefore, the information provided focuses on non-clinical testing rather than studies involving human subjects, AI performance, or expert ground truth.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in numerical terms for the non-clinical tests. Instead, it refers to conformity with relevant ISO and ASTM standards. The reported device performance is that it met these standards, supporting substantial equivalence.
| Test Category | Test Performed | Relevant Standard(s) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In vitro cytotoxicity study, Intracutaneous reactivity study, Skin sensitization study, Acute systemic toxicity, Pyrogenicity study, 14-day repeated dose systemic toxicity study, In vitro haemolysis study, In vitro bacterial reverse mutation (AMES) study, In vitro chromosome aberration study, In vitro mammalian cell gene mutation study, Bone formation and histological study (for Implant/Abutment) | ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-3, ISO 10993-6 | Conformed to relevant ISO standards, supporting biocompatibility. (Implied: accepted by FDA) |
| Static and Dynamic Fatigue Loading | Static and dynamic fatigue test (for Implant and standard abutment) Static and dynamic fatigue test (for Implant and angle abutment) | ISO 14801 | Conformed to ISO 14801, indicating mechanical durability. (Implied: accepted by FDA) |
| Sterilization Validation | Sterilization validation of Gamma irradiation (for Implant) Moist heat validation - microbiological performance qualification (for Abutment) | ISO 11737-1, ISO 11737-2, ISO 17665-1 | Conformed to relevant ISO standards, ensuring sterility. (Implied: accepted by FDA) |
| Packaging Shelf Life Validation | Burst and creep tests, Dye penetration test, Seal peel test, Microbial ranking test (initially and after 2, 3, and 5 years of accelerated aging) | ASTM F1140, ASTM F1929, ASTM F88/F88M, ASTM F1608, ASTM F1980 | Conformed to relevant ASTM standards, ensuring packaging integrity and shelf life. (Implied: accepted by FDA) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The non-clinical testing described typically involves specific numbers of samples (e.g., implants, abutments, packaging units) tested in a lab setting, but these quantities are not detailed.
- Data Provenance: The tests are non-clinical, meaning they are lab-based or in-vitro/in-vivo animal studies (for biocompatibility in some cases, though specific animal models are not detailed). The testing was conducted to support the substantial equivalence submission for a device manufactured by Chang Gung Medical Technology Co., Ltd. in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials subjected to non-clinical tests, not a dataset requiring human expert annotation for ground truth. The evaluation of compliance with standards is done by testing laboratories and regulatory bodies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept typically refers to how disagreements among human reviewers (e.g., radiologists) are resolved in clinical studies or AI evaluations. For engineering and biocompatibility testing, the "adjudication" is based on whether the test results meet the specified criteria of the referenced standards.
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 device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI performance metrics are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's non-clinical testing is adherence to the specified performance characteristics as defined by international standards (ISO, ASTM) for mechanical strength, biocompatibility, sterility, and packaging integrity.
8. The sample size for the training set
Not applicable. Training sets are relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established
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.