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Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Mini and Micro Fragments Reconstruction System – GMReis is composed of plates and screws. The bone plates are made from commercially pure titanium alloy (Ti-4Al-6V) and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 2.0 mm, and the screws range in diameter from 1.5 to 2.7 mm. They are available on different sizes and shapes, according the implantation site and the extension of the fracture.

Mini and Micro Fragments Reconstruction System – GMReis are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according the recommendations provided in the Instructions for Use.

In order to promote a correct placement of the plates and screws, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drills, drill guides, cutting pliers, reamers, screwdrivers, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the implants and promote the success of the procedure.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in osteosyntheses procedures.

This document is a 510(k) premarket notification for the "Mini and Micro Fragments Reconstruction System - GMReis". It describes the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for biocompatibility and mechanical properties. It does not provide a table with specific acceptance criteria and detailed reported device performance values in a quantifiable manner (e.g., specific tensile strength values or fatigue cycles). Instead, it states that the devices meet the requirements of established standards.

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

The document does not specify the exact sample sizes used for the biocompatibility or mechanical testing. It mentions that "tests required" and "mechanical testing" were performed according to the listed standards, implying that sufficient samples were tested to meet the requirements of those standards.

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the manufacturer is GM dos Reis Indústria e Comércio Ltda, located in Campinas, São Paulo, Brazil. The testing would have been conducted by or for this manufacturer.

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

This information is not applicable to this type of device. The "Mini and Micro Fragments Reconstruction System - GMReis" is a metallic bone fixation appliance, not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The performance is assessed through standardized physical and mechanical tests.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple human readers, not for mechanical testing of orthopedic implants.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI-assisted diagnostic tool for which human reader performance would be evaluated with and without AI assistance.

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

No, a standalone study of an algorithm without human-in-the-loop performance was not done. This device is a physical hardware product, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established through adherence to recognized international standards for biocompatibility (ISO 10993-1) and mechanical properties (ASTM F382, ASTM F543) and sterilization (ISO 17665-1, ISO 17665-2). The "truth" is that the device performs as expected under these standardized test conditions. It's not a diagnostic "ground truth" derived from expert consensus or pathology.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a software or AI model that requires a "training set."

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

Not applicable. As this is not a software or AI model, there is no training set or associated ground truth establishment method.

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