Search Results

The Lifecore Stage-1 Angled Abutment is intended to attach to an endosseous implant and provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required.

The Lifecore Stage-1 Angled Abutment System is designed for use with endosseous implants to provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required. The Stage-1 Angled COC Abutment and Screws will facilitate ideal tooth positioning due to lack of available bone, access limitation, or to correct angulation of implant placement. The system consists of 15 and 20 degree angled abutments, angled abutment screw, and angled abutment try-ins. One angled abutment is packaged together with an angled abutment screw to allow the clinician to have the components required for clinical use. The angled abutments and angled abutment screw are manufactured from titanium alloy (Ti 6Al-4V E.L.) which conforms to ASTM Standard Specification F136.

The provided text describes the Lifecore Stage-1 Angled Abutment System, a Class III medical device intended for dental implant support and retention where angle correction is required.

However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics that would typically be reported for the device's clinical or algorithmic performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot fulfill most of your request directly from the provided text. I will, however, extract the information that is present.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., "accuracy > 90%") and their corresponding device performance values are not provided, this table cannot be fully populated. The document only states that the device has "met the design criteria" for various tests.

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

This information is not provided. The document refers to "testing to verify design specifications" but does not detail the sample sizes for these tests (e.g., number of abutments tested for static load) or the provenance of any data beyond indicating it's related to the device's design verification. It appears to refer to in-vitro non-clinical tests rather than human or real-world data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient outcomes to establish ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the non-clinical tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document describes non-clinical engineering and material tests, not studies comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (an abutment system), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been the pre-defined engineering specifications and ASTM standards for static loads, fatigue loads, corrosion resistance, and dimensional accuracy. The device's performance was compared against these established technical benchmarks.

8. Sample Size for the Training Set

Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and regulatory standards, not by iterative training on a data set.

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

Not applicable for the same reasons as point 8.

Ask a specific question about this device