Search Results

The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the proBthetic phase and installation of the progressions who works we 302 for the patient .

Endosseous implant system consists of implants. tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of specific metrics like sensitivity, specificity, or any numerical performance targets.

Here's a breakdown of why I cannot fulfill your request with the given input:

• No Acceptance Criteria: The document describes the device, its intended use, and its similarities to predicate devices, but it does not specify any quantitative acceptance criteria (e.g., "device must achieve X% accuracy").
• No Study Details for Performance: The text mentions "substantial equivalence" to predicate devices, but this refers to the regulatory pathway for market clearance, not a performance study with a test set, ground truth, or statistical analysis. It states that the "CDRH, as well as the Office of Compliance have received a substantial equivalence letter," indicating a regulatory review, not a clinical or technical performance study in the way typically required for AI/diagnostic devices.
• No "Reported Device Performance": Since no acceptance criteria or performance study is detailed, there's no reported numerical performance to include in a table.
• No Details on Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, or Training Set: All these elements are crucial for describing a performance study, and they are entirely absent from the provided text. The document focuses on regulatory equivalence and device description.

Therefore, I cannot generate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or study types because the necessary information is not present in the provided 510(k) summary. This document is focused on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than on providing detailed performance metrics from a dedicated study.

Ask a specific question about this device