Search Results

The Signature Osteosynthesis Plate System is intended for adult patients for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions. The 1/3 Tubular Plate and Compression Plate Small are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the Foot, hand, wrist, and forearm. Additionally, the Compression Plate Narrow and Compression Plate Broad are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the upper extremity and lower extremity, except for the femur and proximal tibia. The Clavicle Plates are intended for use in fixation of fractures, osteotomies, and non-unions of the clavicle in adult patients in whom the clavicular growth plates have fused or in whom the growth plates can be crossed by the plate system.

The Signature Osteosynthesis Plate System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The System utilizes medical grade Titanium alloy. System implants are provided both sterile and non-sterile with instructions for steam sterilization. The sterile implants are provided sterilized in Tyvek packaging. The implants are single use only.

This document describes the regulatory clearance for the Signature Osteosynthesis Plate System. It is a medical device for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions in adult patients.

Here's an analysis of the provided text with respect to acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum tensile strength of X MPa). Instead, it states that the device's strength is "sufficient for their intended use and substantially equivalent to legally marketed predicate devices." The performance data are presented as test modes, and the conclusion refers to the device being "at least as safe and effective" as predicate devices.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify the sample size used for each of the non-clinical tests (Static Four-point Bending, Dynamic Four-point Bending, Static Torsion, Static Axial Pullout).
• Data Provenance: The data are non-clinical (mechanical testing) and therefore do not have a country of origin in the context of patient data. The tests were performed according to ASTM standards, which are international standards. The study is non-clinical.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: This information is not applicable as the study is a non-clinical, mechanical testing study, not a clinical study involving human expert interpretation for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: This is not applicable as the study is a non-clinical, mechanical testing study. Adjudication methods are typically used in clinical trials involving human interpretations or outcomes.

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

• MRMC Study Done?: No. The document explicitly states: "Clinical data and conclusions were not needed for this device." The study was entirely non-clinical (mechanical testing).
• Effect Size with AI vs without AI: Not applicable, as no MRMC study or AI component is mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done?: No. This device is a physical orthopedic implant, not a software algorithm or AI-powered diagnostic tool. Therefore, a standalone performance study in the context of an algorithm is not relevant. The performance studies conducted were mechanical tests of the physical device.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is established by the compliance with specific ASTM (American Society for Testing and Materials) standards for mechanical properties. The test results are compared against the requirements of these standards and against the performance of legally marketed predicate devices. This falls under engineering standards and comparative performance data.

8. Sample Size for the Training Set

• Sample Size for Training Set: This is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device