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The EXPERT - Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting.

The Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:

Mini EXPERT

When used for fixation of bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:

• Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;

• Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and

• Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the ligament at the base of the thumb metacarpal by providing stabilization between the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

EXPERT Knotless and EXPERT Knotless Dual

Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The EXPERT – Joint Fixation System is available in three models. Each model is composed of different medical devices (i.e. plates, surgical suture) assembled together for the purpose of use as a set. Each set is composed of plates from different sizes and shapes made of Titanium Alloy (ASTM F136) associated with non-absorbable surgical sutures and/or surgical meshes made of an Ultra-High Molecular Weight Polyethylene (UHMWPE).

The metallic components are manufactured by GM dos Reis Indústria e Comércio Ltda and the nonabsorbable Surgical Sutures and Surgical Suture Meshes are purchased in bulk from River Point Medical (K100006).

Each EXPERT model comes with a transient use guidewire accessory in the same package. The guidewire is made of Stainless Steel (ASTM F138) to aid in the EXPERT - Joint Fixation System placement.

In order to promote a correct placement of EXPERT – Joint Fixation System, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drill bits, drill guides, plier, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the subject devices and promote the success of the procedure.

This document describes the EXPERT - Joint Fixation System and its substantial equivalence to predicate devices, focusing on the mechanical performance of the device rather than AI/software performance. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML medical device submissions (such as ground truth establishment involving expert consensus, MRMC studies, or standalone algorithm performance) are not applicable here.

The "study" in this context refers to mechanical testing that demonstrates the device's physical performance characteristics are comparable to legally marketed predicate devices.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to existing predicate devices through mechanical testing. The document states:

• "The performance of the subject devices compared with the predicate devices are demonstrated through mechanical testing."
• "The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices."

Since this is a 510(k) submission for a physical medical device (joint fixation system) and not an AI/ML diagnostic or prognostic tool, the "performance" is related to its physical and functional characteristics (e.g., strength, durability, fixation capability) as compared to the predicates. The document does not explicitly list quantitative acceptance criteria values or detailed reported device performance data in a table format. Instead, it relies on the conclusion that mechanical tests confirm comparability.

Table of Acceptance Criteria and Reported Device Performance (Inferred from 510(k) Context):

Study Information (Mechanical Testing for Substantial Equivalence)

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

   • Sample Size: Not specified in the provided summary. For mechanical testing of medical devices, sample sizes are typically determined by statistical rationale to ensure robustness and representativeness of the device's performance.
   • Data Provenance: The testing was conducted as part of the submission by GM dos Reis Indústria e Comércio Ltda, a Brazilian company. The data would be prospective, as it was generated specifically for this 510(k) submission.

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

   • Not Applicable. This is a submission for a physical joint fixation system, not an AI/ML device requiring human expert annotation of medical images or clinical outcomes for ground truth. Ground truth for mechanical performance is established through standardized engineering tests and material science evaluations.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2.

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

   • Not Applicable. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists) in diagnostic tasks. The EXPERT - Joint Fixation System is a physical implant.

5. Standalone (Algorithm Only) Performance:

   • Not Applicable. No algorithms or software are involved in the primary function or assessment of this physical device.

6. Type of Ground Truth Used:

   • Engineering Specifications and Standardized Test Methods: For mechanical performance, ground truth is established by universally accepted engineering principles, material standards (e.g., ASTM, ISO), and validated test methods (e.g., fatigue testing, tensile strength). For biocompatibility, it's established by adherence to ISO 10993 series standards and AAMI/ANSI ST72.

7. Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of mechanical testing for a physical medical device. Device design and manufacturing processes are refined through engineering iterations.

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

   • Not Applicable. See point 7.

Summary of Information NOT Applicable to this Submission:
Due to the nature of the device (a physical joint fixation system) and the regulatory submission (510(k) based on substantial equivalence through mechanical testing), the following elements, commonly associated with AI/ML device evaluations, are not found in the provided document:

• Detailed quantitative performance metrics in a readily available table.
• Specific sample sizes for a "test set" in the context of clinical/image data.
• Data provenance involving patient demographics or retrospective/prospective medical data collection.
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies.
• Standalone algorithm performance.
• Training set information.

The document unequivocally states: "No clinical data were included in this submission." This further confirms that the evaluation focused on physical and mechanical properties, not clinical outcomes or human performance with AI assistance.

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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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