Search Results

The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.

This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.

Here's an attempt to address the request based only on the available information, noting where information is absent:

Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified for any of the non-clinical tests (sterilization, biocompatibility, mechanical retention). The document mentions "mechanical denture retention testing" but does not give the number of samples tested.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/bench testing) rather than human clinical data. The document explicitly states: "No clinical data were included in this submission."
• Retrospective or Prospective: Not applicable as these are non-clinical, bench-top tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

• Not applicable. This document describes testing for a physical dental device, not an AI/ML system requiring expert-established ground truth for a test set of images or clinical data. The performance claims are based on engineering and material science testing.

4. Adjudication Method for the Test Set:

• Not applicable. This concept (e.g., 2+1, 3+1) is relevant for establishing ground truth from multiple human readers/experts, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is a type of clinical study used to assess the performance of diagnostic devices or AI systems, especially compared to human readers. This document explicitly states "No clinical data were included in this submission," and the device is a physical dental attachment, not a diagnostic imaging or AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI system. Its "performance" is inherent to its physical properties and mechanical function when used as intended.

7. The Type of Ground Truth Used:

• For the mechanical retention testing, the "ground truth" would be the direct measurement of tensile force required to dislodge the attachment, compared against a pre-defined threshold or established "worst case sticky food" force. This is a directly measured physical parameter, not an expert consensus or pathology result.
• For biocompatibility and sterilization, the "ground truth" is adherence to the specified ISO standards after testing.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the described device.

Ask a specific question about this device