(86 days)
The 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.
The 3i Patient-Specific Overdenture Bars are designed to match individual patients.
This 510(k) premarket notification for Implant Innovations, Inc.'s 3i Patient-Specific Overdenture Bars focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software-as-a-medical-device (SaMD).
Therefore, the provided document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, as these types of studies are typically associated with validating the performance of diagnostic or therapeutic devices that rely on novel algorithms or measurements.
The document primarily focuses on:
- Device Description: 3i Patient-Specific Overdenture Bars are designed to match individual patients and are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in partially or edentulous patients.
- Intended Use: To support multiple tooth prostheses in the mandible or maxilla, with the prostheses being screw-retained to the abutment.
- Predicate Devices: Various overdenture bars (Hader, Dolder, Primary) and specifically K974150 Nobel Biocare, Inc. Procera® Preparable Abutment System.
- Safety and Effectiveness Summary: Mentions historical problems with overdenture bars (fractures of screws, loose screws, improper mating leading to inflammation) but does not provide details on how the 3i device addresses these with specific performance data.
- Substantial Equivalence: The FDA's letter states the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as the predicate devices, or if there are differences, they do not raise different questions of safety and effectiveness.
In summary, the provided document is a 510(k) clearance letter for a medical device (patient-specific overdenture bars) that is demonstrating substantial equivalence to existing predicate devices. It does not contain the detailed performance study information, including acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies, that would be associated with the validation of an AI/SaMD diagnostic or therapeutic product.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)