(84 days)
Straumann® Ceramic Healing abutments are indicated to be placed in the patient's mouth at the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.
Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols. They are placed out of occlusion and do not support a prosthetic restoration. The Ceramic Healing Abutments are two-piece devices that feature a ceramic ring in various heights to accommodate individual gingival thickness, with a preassembled TAN basal screw. The pre-assembled TAN basal screw is fixed into the ceramic ring and cannot be removed.
The provided text is a 510(k) Summary for a medical device (Straumann® Ceramic Healing Abutments). It describes the device, its intended use, and how it was determined to be substantially equivalent to predicate devices. However, this document does not contain the specific information required to answer your questions about acceptance criteria or a study proving the device meets those criteria, especially in the context of an "AI/algorithm-only" medical device, or a multi-reader multi-case study with human readers assisted by AI.
This 510(k) deals with a physical medical device (dental abutments) and its substantial equivalence is primarily based on material composition, intended use, and physical/biocompatibility testing, not on algorithm performance data.
Therefore, I cannot extract the requested information from the provided text. The document focuses on:
- Device identification: Trade/Device Name, Regulation Number, Classification, Product Code.
- Submitter information: Company and contact details.
- Predicate devices: List of devices used for comparison.
- Device description: Physical characteristics and materials.
- Intended use and Indications for Use: What the device is for.
- Technological Characteristics Comparison: A table comparing features of the proposed device with predicate devices (materials, connections, dimensions).
- Performance Testing (for a physical device): Biocompatibility (ISO 10993-1, 5, 12, 17, 18), Sterilization Validation (ISO 11135), and Endotoxin testing (LAL Endotoxin Analysis).
There is no mention of:
- Acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, AUC).
- A test set of data (e.g., images for an AI algorithm).
- Ground truth establishment by experts.
- Multi-reader multi-case studies, or AI assistance for human readers.
- Standalone algorithm performance.
- Training set details for an AI model.
To answer your detailed questions, you would typically need a document that describes the clinical performance study of an AI-enabled medical device, which is not what this 510(k) summary is.
§ 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.)