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The Universal Clamp® Spinal Fixation System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
   The Universal Clamp® Spinal Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp® Spinal Fixation System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical device implants made of either stainless steel or titanium whenever "wiring" may help secure the attachment of other implants. The Universal Clamp® is available in both stainless steel and titanium versions. The stainless steel clamp is available in 3 sizes: 5.5, 6.0 and 6.35mm. The titanium clamp is available in 2 sizes of 5.5 and 6.0 mm. The different sizes are designed for compatibility with rods of the same sizes. A woven polyester band and locking screw are also provided.

The provided text is a 510(k) summary for the Zimmer Spine Universal Clamp Spinal Fixation System. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The 510(k) process for medical devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological characteristics and performance data (often mechanical testing for implants) rather than clinical studies with specific performance metrics akin to those for AI/ML devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for an AI/ML device).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study or human-in-the-loop performance.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a physical medical implant (a spinal fixation system), not a software or AI/ML device, and thus the type of information you are asking for (acceptance criteria and studies for AI/ML performance) is not present.

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