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ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
  ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.

ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.

ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.

ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

ARMARTM / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically bone plates and screws. It does not contain information about an AI/ML device, AI acceptance criteria, or a study proving an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding AI device performance, acceptance criteria, sample sizes, expert ground truth, MRMC studies, or training/test set details from this document. The document describes the substantial equivalence of bone fixation appliances to existing predicate devices based on technological characteristics and mechanical performance data (e.g., static four-point bending, dynamic four-point bending, static torsion, static axial pullout).

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The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.

The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These new plates incorporated variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6- and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fragment capture and fracture reduction.

The provided document is a 510(k) summary for the Synthes 2.4mm Variable Angle LCP Volar Rim Distal Radius System. This type of submission is for medical devices that are substantially equivalent to a predicate device and, as such, does not contain acceptance criteria and studies demonstrating device performance in the same way a de novo or PMA submission would.

Instead, the documentation focuses on demonstrating substantial equivalence through:

1. Comparison of intended use and design features to predicate devices.
2. Mechanical testing to show comparable performance in terms of mechanical strength and fatigue to predicate devices.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not typically included or required for a 510(k) submission based on substantial equivalence to existing devices. Such detailed studies are usually reserved for novel devices or those with higher risk classifications where clinical efficacy and safety need to be established independently.

However, I can extract the information related to the device description and the type of testing performed to support substantial equivalence.

Here's a breakdown of what can be extracted from the provided text, addressing the closest relevant points:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The general implied acceptance criterion is "comparable mechanical strength and fatigue" to predicate devices.
• Reported Device Performance: The document states that "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in regards to mechanical strength" and "Testing conducted to support the substantial equivalence for the 2.4mm VA-LCP Volar Rim Distal Radius Plates was aimed to assess the fatigue strength of the subject device." It also mentions "Functional & mechanical testing demonstrates the comparable mechanical and functional properties of the 2.4mm Variable Angle LCP Volar Rim Radius System to the predicate devices."

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified. Mechanical testing typically involves a set number of specimens, but this detail is not provided in a 510(k) summary.
• Data Provenance: The testing was conducted by Synthes (USA), the sponsor of the device. The data would be internal to the company, performing the tests to demonstrate equivalence. It is not patient data, but rather mechanical test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Ground Truth/Experts: This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards and test methods, not by expert consensus on clinical data. No human experts are involved in establishing a "ground truth" for mechanical properties in this context.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined engineering parameters, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is a medical implant (bone plate) used for fixation of fractures, not an image-based diagnostic or AI-powered device. Therefore, MRMC studies are irrelevant.

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

• Standalone Performance: No. This is not an algorithmic device. The performance is physical and mechanical.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth: For this type of device and study, the "ground truth" refers to established engineering standards for mechanical properties (e.g., strength, fatigue limits) and the mechanical properties of the predicate devices. It is based on objective physical measurements and engineering analysis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no "training set" as this is not a machine learning/AI device. Finite element analysis (FEA) was used, which involves computational models, not a data training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable for the same reason as above. FEA relies on material properties and geometric models, not a "ground truth" for a training set. The FEA was used to "determine the worst case construct" for further dynamic loading testing.

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