Search Results

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 System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The Universal Clamp Spinal Fixation System consists of a woven band with a stiff guiding section at one end and metal buckles at the other end, implantable grade metal clamps that mate with 4.5mm - 6.35mm diameter rods, and an implantable grade metal locking screw that tightens the clamp over the band securing it to the connecting rod.

Implants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

This document is a 510(k) premarket notification for the Universal Clamp Spinal Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

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

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

The document does not specify the exact sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798."

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

This information is not applicable. The device is a spinal fixation system, and its performance is evaluated through mechanical testing, not through expert-reviewed diagnostic image interpretation or similar processes that would require establishing a ground truth based on expert consensus.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, not for mechanical performance testing of an implantable device.

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

An MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device directly involving human readers.

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

This information is not applicable. The device is a mechanical implant, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used

The ground truth for evaluating the device's performance was established through mechanical testing standards, specifically ASTM F1798. This standard likely defines specific parameters, test methods, and pass/fail criteria for spinal fixation systems.

8. The sample size for the training set

This information is not applicable. The Universal Clamp Spinal Fixation System is a mechanical implant, not a machine learning or AI-based device that would require a training set.

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

This information is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device