(242 days)
CAMLOG implants are used to support dental prostheses in the upper and lower jaws. They may be used for functional and aesthetic oral restoration of partially edentulous and edentulous jaws using crowns, bridges, partial or complete prostheses, which are connected to CAMLOG implants using suitable components. CAMLOG Ball Abutments support implant retained mucosa supported overdentures. CAMLOG Bar Abutments (including bases) support custom milled or prefabricated bars for overdentures. CAMLOG Healing Caps (Cylindrical, Wide Body, Bottleneck, and for Bar Abutment) displace the gingiva from the space above the CAMLOG implant or bar abutment during the CAMLOG implant healing time and serve for proper gingiva shaping.
The following list of products are used solely in combination with the implantation of CAMLOG dental implants. Healing caps of specific diameters and shapes are fixated on the implants to disclace the gingiva from the space above the implant during the implant healing time and serve for proper gingiva shaping. They are offered in three different shapes; cylindrical, wide body and bottleneck and are available in diameters of 3.3, 3.8, 4.3, 5.0 and 6.0mm. The cylindrical and wide body healing caps are available in Gingival Heights (GH) of 2.0, 4.0 and 6.0mm. The bottleneck healing cap is available in two Gingival Heights of 4.0 and 6.0mm. This healing cap is connected to the bar abutment and is intended to form the gingival shape similar to the healing caps described above. There are two healing caps for use with the bar abutment, which are made of TiAl6V4. Both have an overall height of 3.65mm, but differ in the base diameter of 4.30 or 6.0mm maasured at the outer tube wall. Ball abutments are used for implant-retained mucosa-supported restorations, such as dentures. The ball abutment technique is used on Camlog implants in the maxilla or mandible. When using the ball abutment, the angle of the implant axes must not be more than 10°. Ball abutments with the following diameters are available: 3.3, 3.8, 4.3 and 5.0mm. The male part for each diameter is available in protrusion heights of 1.5, 3.0 and 4.5mm. There are a total of 12 different size ball abutment systems being offered by Altatec. Camlog bar abutments serve to support custom-milled or prefabricated bars to which an overdenture is attached. The bar abutment technique is used on Camlog implants in the maxilla or mandible. The bar abutments are available in various diameters, which include 3.3. 3.8, 4.3, 5,0 and 6.0mm. Each diameter is available in three different protrusion heights of 0.5, 2.0 and 4.0mm. There are a total of 15 different sizes that will be offered for sale. The purpose of each specific base is to have a base adapted in geometry and materials selection to each of the following processes: soldering, laser-welding, and cementing. The selection of a specific processing method is made by the dental laboratory. The purpose of the specific gold coping is to have a base adapted in geometry and materials selection to the casting process. The selection of a specific processing method is made by the dental laboratory. We are offering two gold copings for bar abutment cast-on of different sizes, which are compatible to the bar abutments of 3.3, 3.8 and 4.3mm diameter or of 5.0 and 6.0mm diameter. There are two prosthetic screws for bar abutment, both 5.5 mm long. They vary by diameter (2.10 and 2.50mm) of the cylindrical shank and by the size of the thread (M1.6 and M2). The screws serve to fix the bases or the gold coping to the bar abutment. There are two screws for bar abutment. Both screws are 20.5 mm long. They vary by diameter (2.1 and 2.5mm) of the cylindrical shank and by the size of their threads (M1.6 and M2). The thread serves to guide and stabilize the impression post through the hollow core of which the screw is directed.
The provided text is a 510(k) summary for the CAMLOG Endosseous Dental Implant Abutments, Healing Caps and Accessories. This document is a premarket notification to the FDA for a medical device and describes its intended use, design, materials, and comparison to predicate devices, ultimately asserting substantial equivalence to existing legally marketed devices.
However, a 510(k) summary (or the full 510(k) submission, typically) does not include acceptance criteria, performance studies with sample sizes, expert ground truth adjudication methods, or comparative effectiveness studies (MRMC or standalone) in the manner typically associated with AI/ML medical device evaluations.
The information requested in the prompt (acceptance criteria, study details, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC or standalone performance) is characteristic of a performance evaluation for software-as-a-medical-device (SaMD) or devices involving AI/ML components, particularly when clinical performance is being assessed for diagnostic or assistive functions.
In the context of this 510(k) for dental implant components, the "performance" discussed is primarily related to material properties, design specifications, and functional equivalence to predicate devices, rather than the kind of AI/ML performance metrics you've asked for. The "study" here refers to the bench testing and comparisons made to demonstrate that the device is substantially equivalent to predicate devices already on the market, not a clinical trial or AI model validation study.
Therefore, I cannot extract the requested information from the provided text as it is not present in a 510(k) submission for this type of medical device. The document aims to demonstrate substantial equivalence to predicate devices through comparisons of design, materials, intended use, and functional characteristics, not to present a detailed clinical performance study with the specific metrics requested for AI/ML.
Here's an explanation of why the requested information is absent:
- Acceptance Criteria & Device Performance: The document provides comparison tables (e.g., for Healing Caps, Bases, and Gold Coping) showing the specifications (diameters, material, intended use) of the subject device against predicate devices. The "acceptance criteria" here implicitly are that the subject device's characteristics are sufficiently similar or equivalent to the predicate devices to demonstrate safety and effectiveness. There are no quantitative performance metrics (like sensitivity, specificity, AUC) that would be relevant for a non-AI/ML implant component.
- Sample Sizes (Test/Training), Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These concepts are entirely inapplicable to the content of this 510(k). This is a filing for physical dental implant components, not a software algorithm or an AI-powered diagnostic tool. There are no "test sets" or "training sets" of data in the AI/ML sense, no "ground truth" established by experts for image interpretation or diagnosis, and therefore no need for adjudication methods or MRMC studies.
- Type of Ground Truth: The "ground truth" for these physical components is their physical and chemical properties, measured through standard engineering and material science tests, and their functional performance as demonstrated in mechanical testing or in vitro evaluations (which are typically summarized or referenced, not detailed studies in the 510(k) summary itself).
In summary, the provided document is for traditional medical device clearance and does not contain the information requested, which is specific to the evaluation of AI/ML-driven medical devices.
§ 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.)