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The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The EUROPA™ Pedicle Screw System is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements.

The pedicle screws are manufactured from Ti-6Al-4V ELI alloy (ASTM F136). The rods are manufactured from Molybdenum-47.5Rhenium alloy (ASTM F3273) or cobalt chromium alloy (ASTM F1537).

The system also includes adjustable-length transverse rod cross connectors manufactured from Ti-6Al-4V ELI alloy (ASTM F136-13) that may be used in EUROPA™ systems with cobalt chromium rods where increased structural rigidity of the construct is needed.

The purpose of this 510(k) submission is to obtain market clearance for additional EUROPA™ Pedicle Screw System rod to rod connectors manufactured from Ti-6AI-4V ELI alloy (ASTM F136-13) which may be used to connect or extend constructs in an in-line or parallel fashion.

This document, a 510(k) summary for the Europa Pedicle Screw System, describes a medical device, specifically a pedicle screw system for spinal fixation, and its substantial equivalence to previously marketed devices. It does not contain any information about an AI/ML powered device, acceptance criteria, or a study that proves the device meets acceptance criteria.

Therefore, I cannot fulfill your request as the provided text does not contain the necessary information regarding:

• Acceptance criteria for an AI/ML device.
• Reported device performance against such criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Expert involvement in ground truth establishment or adjudication.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Ground truth methodology.

The supplied text is a standard FDA 510(k) clearance letter and summary for a physical medical implant (pedicle screw system), focusing on its mechanical performance and substantial equivalence to predicates, not on AI/ML diagnostic or assistive technology.

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The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The EUROPA™ Pedicle Screw System is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements. The pedicle screws are manufactured from Ti-6Al-4V ELI alloy (ASTM F136). The rods are manufactured from Molybdenum-47.5Rhenium alloy (ASTM F3273) or cobalt chromium alloy (ASTM F1537).

This document is a 510(k) summary for the EUROPA™ Pedicle Screw System, seeking market clearance for sterile-packaged rod components. It is a Class II medical device, and the submission is a "Special 510(k)" because it is nearly identical to previously cleared devices (K180337, K182970), with the only change being the terminal sterilization method for the rod components.

Therefore, the document does not provide information about acceptance criteria or a study proving the device meets those criteria for the following reasons:

• No new performance data is presented or required. The submission explicitly states under "IX. PERFORMANCE DATA": "Performance data is not provided in this submission." This is because the device is largely identical to its predicate devices, and the change (sterilization method) is addressed through an "Adequate description of the sterilization method" rather than a clinical or performance study.
• This is a 510(k) summary. A 510(k) submission generally demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new performance studies as would be required for a PMA (Premarket Approval Application). A "Special 510(k)" limits the required information even further when the modifications do not affect the device's fundamental function, safety, or effectiveness.

Based on the provided text, I cannot extract the requested information regarding acceptance criteria and performance study details because the document explicitly states that no performance data is provided for this submission.

The document's purpose is to get clearance for a minor change (sterilization of a component) to an already cleared device, not to present novel performance data.

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The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system as defined in 21 CFR 888.3070. The system is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements.

The pedicle screws are available in 5 different diameters from Ø4.5mm to Ø8.5mm, are solid or cannulated with lengths ranging from 25mm to 80mm, and are manufactured from Ti-6Al-4V ELI alloy (ASTM F136-13). The rods are Ø4.5mm in diameter with lengths ranging from 30mm to 300mm, are available in both straight or curved configurations to accommodate Open and MIS applications, and are manufactured from Molybdenum-47.5Rhenium alloy (MoRe®, ASTM F3273-17).

The pedicle screws and rods are intended to be implanted via a posterior approach. Implants are single use and the system is provided non-sterile.

This is a 510(k) summary for a medical device called the EUROPA™ Pedicle Screw System, which is a thoracolumbosacral pedicle screw system. The document states that performance data was provided in support of the substantial equivalence determination to a predicate device.

However, the provided text does not contain information about:

1. Acceptance criteria and reported device performance in a table. The document lists the types of tests performed (Biocompatibility, Mechanical, Corrosion) but does not provide specific acceptance criteria or the numerical results of these tests.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance. The device described is a physical implant, not an algorithm.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of the device, its indications for use, and a comparison to a predicate device. It briefly mentions performance data (biocompatibility, mechanical, corrosion testing) but does not detail the results or the methodology for proving acceptance criteria related to these tests.

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The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system as defined in 21 CFR 888.3070. The system is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements.

The provided text describes a 510(k) submission for a medical device, the EUROPA™ Pedicle Screw System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on studies involving human performance or AI. Therefore, the document does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to AI or human-in-the-loop performance.

The "Performance Data" section (Section X) explicitly states:
"The following performance data were provided in support of the substantial equivalence determination.

• static and dynamic compression bending - ASTM F1717
• static torsion ASTM F1717 ●"

This indicates that the performance data provided are for mechanical and material testing of the pedicle screw system, not for clinical performance, diagnostic accuracy, or human-AI interaction.

Therefore, I cannot extract the requested information from the provided document.

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