(14 days)
Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.
The provided text describes a 510(k) summary for a medical device modification, specifically the "Astra Tech Implant System, New Component." However, it does not contain information about acceptance criteria, the study that proves device meets acceptance criteria, detailed performance data, sample sizes, ground truth establishment, or expert involvement.
The document is a regulatory submission discussing the device's administrative information, intended use, description, and equivalence to a predicate device. It explicitly states that the modification "has the same intended use, uses the same operating principle, incorporates the same basic design, and is packaged using the same materials and processes" as the unmodified predicate device. This implies that the modification is considered substantially equivalent based on these similarities, rather than requiring a new, comprehensive performance study against specific acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance data.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not present in the provided 510(k) summary. The 510(k) process for device modifications often focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new, extensive performance studies with detailed acceptance criteria if the changes are minor and do not alter the fundamental safety or effectiveness of the device.
§ 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.)