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AxSOS 3 Ti is intended for long bone fracture fixation

Indications include:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions and malunions
• Normal and osteopenic bone
• Osteotomies
• Periprosthetic fractures of the femur and proximal tibia.

The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:

• Periprosthetic fractures
• Diaphyseal and metaphyseal areas of long bones in pediatric patients

The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis

The AxSOS 3 Ti system (also referred to as the AxSOS 3 Ti Locking Plate system) is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws (limited to waisted compression plates) . The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components are available sterile and non-sterile and are manufactured from titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The AxSOS 3 Ti 5.0mm Cable Plug is categorized as permanent, direct bone/tissue patient contacting implant with contact duration >30 days. It is manufactured from titanium alloy (ASTM F136, Ti6Al4V-ELI) and is Type II anodized. It is designed to be used in combination with the 5.0mm AxSOS 3 Ti system. It is an aid for internal fixation component used in conjunction with the AxSOS 3 Ti 5.0mm distal lateral femur, broad compression and narrow compression plates. The Cable Plug is threaded or clicked into a 5.0mm universal locking hole of the AxSOS 3 Ti plates and provides a positioning point for a cerclage cable.

The provided text is related to a 510(k) premarket notification for a medical device (AxSOS 3 Ti) and focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through AI/ML performance.

The document discusses:

• Device Name: AxSOS 3 Ti
• Regulation Number and Name: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories) and 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Regulatory Class: Class II
• Product Code: HRS, HWC
• Indications for Use: Long bone fracture fixation, including various types of fractures, non-unions, malunions, normal and osteopenic bone, osteotomies, and periprosthetic fractures. Also specific indications for Waisted Compression Plates in pediatric patients and for the scapula and pelvis.
• Predicate Devices: AxSOS 3 Ti (K153379 & K162439) and Dall-Miles Homogenous Vitallium Cable (K961283).
• Reference Devices: Fixos Screw System (K133451) and Asnis III Cannulated Screw System (K000080).
• Non-Clinical Testing: Performed to ASTM standards for pull-out, dynamic compression, and MR compatibility (magnetically induced displacement force, torque, heating, and image artifacts).
• Clinical Testing: Not required for this submission.

Therefore, we cannot answer your request based on the provided text because it does not contain information about:

• Acceptance criteria and reported device performance related to AI/ML. The device is a bone fixation system, not an AI/ML-driven diagnostic or therapeutic device.
• Sample size for a test set (in the context of AI/ML).
• Data provenance (country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI/ML.
• Standalone (algorithm only) performance for AI/ML.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is a regulatory approval letter for a conventional medical device based on engineering and materials testing, not an AI/ML performance study.

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