(169 days)
NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constraints. After customization, be sure to use only dental nonprecious metal (Co-Cr-Mo alloy) for casting to make the prosthesis When cast a prosthesis with NP-Cast Abutment System, Post height above the transmucosal collar of NP-Cast Abutment System has to be taller than 4mm and Maxmimum angulation has to be less than 30°. The NP-Cast Abutment System consists of Abutment and Abutment Screws.
The provided document is a 510(k) premarket notification for a medical device (NP-Cast Abutment System), not a study report detailing performance against acceptance criteria for an AI/ML diagnostic or predictive device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or available in this document.
However, I can extract information related to the device's non-clinical testing which serves as the "study" for this type of device and the "acceptance criteria" through comparison with predicate devices.
1. Acceptance Criteria and Reported Device Performance
For this type of device (a dental abutment), "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices and meeting relevant performance standards, particularly mechanical safety. The document focuses on showing that the NP-Cast Abutment System is equivalent in material, indication for use, design, and technological characteristics to its predicates.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device should be similar to predicates in intended use, technology, claims, material composition, and performance characteristics. | The NP-Cast Abutment System is "substantially equivalent in design, function and intended use" to the SimpleLine II Abutment System (K112045) and two OSSTEM Prosthetic Systems (K110308, K081575). The materials (Co-Cr-Mo Alloy) and intended use are identical or highly similar to predicates. |
| Biocompatibility | The device's materials must be biocompatible for their intended use within the human body. | "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations." (Specific results not detailed, but conformance is stated). |
| Mechanical Fatigue Strength | The device must withstand expected physiological loading conditions without fracture or failure, as evaluated by relevant testing standards (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment"). Specific acceptance limits would be defined by the standard and comparison to predicate performance for "worst-case scenario." Post height above transmucosal collar > 4mm and maximum angulation 4mm and maximum angulation |
§ 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.)