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The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:

• Open and closed fractures
• Osteotomies
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (orthoplastic surgery)
• Joint arthrodesis
• Infected fractures
• Correction of segmental bony or soft tissue defects
• Management of comminuted intra-articular fractures
• Bone transport
• Revision procedures where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. HA coated half pins and tensioned wires are then used to fixate and stabilize bones and joints.

Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods, threaded pillars, rancho cube pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and HA coated half pins, manufactured from stainless steel, available in multiple diameters and lengths. HA coated half pins are provided sterile packed while all other system components are provided non-sterile.

All External Fixation components are for single use only.

The provided FDA 510(k) clearance letter and accompanying Special 510(k) Summary for the Extremity Medical External Fixation System do not contain information describing the acceptance criteria and a study proving the device meets those criteria in the context of an AI/Software as a Medical Device (SaMD).

The document is for a physical medical device (an external fixation system), not a software or AI-driven device. Therefore, the questions about sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth for training was established are not applicable to this submission.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Design comparison: Listing similarities and differences in components, materials, and technological elements.
• Non-clinical testing: Mechanical testing in accordance with ASTM F1541-17 standard.
• Engineering analysis: Comparing the subject device's components to the predicates.

The "acceptance criteria" for this device would typically be defined by the performance requirements outlined in the relevant ASTM standard (ASTM F1541-17, titled "Standard Specification and Test Methods for External Skeletal Fixators") and demonstrated through the mechanical testing.

Therefore, I cannot provide the requested information as it does not exist in the context of this specific FDA submission.

If you have a document relating to an AI/SaMD, I would be happy to analyze it for the specific criteria you've outlined.

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The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:
Open and closed fractures
Osteotomies
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis, infected union, non-union, or malunion of long bones
Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
Correction of bony or soft tissue deformity (orthoplastic surgery)
Joint arthrodesis
Infected fractures
Correction of segmental bony or soft tissue defects
Management of comminuted intra-articular fractures
Bone transport
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Charcot foot reconstruction
Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
Ankle distraction (arthrodiastasis)
Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. Pins and tensioned wires are then used to fixate and stabilize bones and joints.

Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods and threaded pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and half pins, manufactured from stainless steel, available in multiple diameters and lengths.

All External Fixation components are for single use only.

The original document is a 510(k) summary for the Extremity Medical External Fixation System. It describes a medical device, its indications for use, and a comparison to predicate devices, focusing on non-clinical testing for substantial equivalence.

It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria. The document focuses on the substantial equivalence of a physical external fixation system through engineering analysis and static/dynamic construct testing, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/SaMD from this document. The sections you asked about, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not relevant to the content of this 510(k) summary for a physical medical device.

Ask a specific question about this device