(79 days)
The I2A Dental Implant System and I2C Dental Implant System are in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The 12A Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The J2A Dental Implant System and J2C Dental Implant System are internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media).
The provided document is a 510(k) summary for the J2A Dental Implant System and J2C Dental Implant System. It presents a comparison to predicate devices to establish substantial equivalence, rather than a study proving performance against acceptance criteria in the context of an AI/software as a medical device (SaMD).
Therefore, I cannot extract information related to:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth for test set.
- Sample size for training set.
- Ground truth establishment for training set.
The document discusses non-clinical testing which was conducted to demonstrate substantial equivalence, but not a study of the device's performance against specific clinical acceptance criteria in the way an AI/SaMD would be evaluated. It states:
Non-Clinical Testing:
- Risk analysis was conducted according to ISO14971 to demonstrate that modifications to the company's own predicate, Hero II Dental Implant System (K121047), are substantially equivalent.
- Modifications evaluated include:
- Fixture thread design change.
- Fixture size addition.
- Coating area expansion for one-piece type abutments.
- Abutment size addition.
- Additional predicate devices of similar design and dimensions were identified to determine substantial equivalence.
- Based on the risk analysis, the shelf-life, sterilization, biocompatibility, and performance testing of the predicate, Hero II Dental Implant System (K121047), is applicable to the subject device.
Conclusion on Substantial Equivalence:
The document concludes that the J2A Dental Implant system and the J2C Dental Implant system are substantially equivalent to the predicate devices because they:
- Have the same intended use.
- Use the same operating principle.
- Incorporate the same basic design.
- Incorporate the same material and surface treatment.
This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a clinical study against specific acceptance criteria.
§ 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.