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The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• · Fracture fixation, including single, segmental, and comminuted fractures
• · Revision, including nonunion and malunion
• · Intra- and extra-articular fractures
• · Compression fracture
• · Displaced fracture
• · Reconstruction
• · Replantation
• · Arthrodesis
• · Osteotomy

VariAx 2 is a system used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, as well as no mention of sample sizes, data provenance, expert panels, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) premarket notification summary for the VariAx 2 System, which is a medical device for internal fixation. It discusses the device's substantial equivalence to predicate devices based on non-clinical mechanical testing.

Therefore, I cannot provide the requested information.

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The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.

The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws and lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 5 mm to 20 mm. The lag screws and k-wires are used for fixation independent of the plates. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the k-wires are made of titanium alloy per ASTM F136. All plates and screws are provided sterile and non-sterile.

The provided text describes a 510(k) submission for the Acumed Hand Plating System, which is a medical device for orthopedic fixation. It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device.

The document explicitly states: "The non-clinical testing enclosed in this submission includes static and cyclic performance testing and engineering analysis." This refers to mechanical and engineering tests, not studies related to algorithm performance or human-in-the-loop improvements.

Therefore, for your request regarding AI/algorithm acceptance criteria and studies, the provided text does not contain the necessary information. It is a traditional medical device submission focused on substantial equivalence to existing predicate devices based on design, materials, and mechanical performance.

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The VariAx™ Elbow System is intended for fracture fixation of long bones. Indications include:

• Distal Humerus
• Proximal Ulna

This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Elbow System are intended to add different types of plates and screws to the Stryker® Plating System portfolio.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the VariAxTM Elbow System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and its substantial equivalence to other Stryker plating systems.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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