(88 days)
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. The temporary coping fits over the Straumann solid abulments and has radial projections that facilitate the retention of added acrylic or composite materials to form a temporary restoration.
The provided text is a 510(k) summary for a medical device (Straumann Temporary Coping) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The FDA 510(k) process for this type of device (Straumann Temporary Coping, classified as an accessory to a dental implant abutment, NHA) primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a performance study against those criteria in the same way one might for a novel diagnostic AI algorithm.
Therefore, I cannot fulfill your request for the specific points, as the provided text does not contain the necessary information. The document focuses on:
- Device Description: What the Straumann Temporary Coping is and its intended use.
- Predicate Devices: Identifying similar devices already on the market.
- Basis for Substantial Equivalence: Arguing that the new device is similar in design and intended use to the predicate devices.
- Regulatory Clearance: The FDA's letter granting clearance based on substantial equivalence.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training was established.
This is because the Straumann Temporary Coping is a physical dental accessory, not a software-based diagnostic device where such performance metrics and studies would typically be required for a 510(k) submission. For physical devices, particularly those claiming substantial equivalence, the focus is often on material biocompatibility, mechanical properties (if relevant), and functional similarity to predicates, rather than statistical performance against expert-derived ground truth on image data.
§ 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.)