(147 days)
The VERSALOK™ Screw Assembly is supplied as an alternative component for use with the WRIGHTLOCK™ Postedor Spinal Fixation System to fix the spine for appropriate indications apply when used as a pedicle screw.
A WRIGHTLOCK™ construct with screws attached to the pedicies of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used for the treatment of severe spondylolisthesis (Grade 3) at the fith lumbar - first sacral (LS-S1) vertebral joint. The device is intended to be implanted using a posterior surgical approach and removed after development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the system are also indicated to provide temporary stability of the thoracic, thoracolumbar. or lumbar spino (T1 to S1) during bony fusion healing secondary to: (1) Unstable spinal fractures (such as fracture diskcations) or spinal tumors; (2) Degeneralive disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); (3) Spinal curvatures (such as idiopathic scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: progressive, despite other forms of treatment; detrimental to cardiopulmonary function; interfering with spinal mechanics or causing severe back pain; or cosmetically unacceptable, progressive, and painful.
The VERSALOK™ Screw Assembly is a polyaxial screw assembly consisting of screws, locking sleeves, and caps. The system is designed to accommodate the rods of the commercially available WRIGHTLOCK™ Posterior Spinal Fixation System (K950074-SE 08/11/95). The system features a low profile as well as a top loading design. It allows for up to 8mm offset from the rod and up to 30 degrees of angulation in all planes prior to final locking. The VERSALOK™ Screw Assembly is available in a range of sizes to fit varying anatomical requirements.
The provided text describes a medical device, the VERSALOK™ Screw Assembly, and its performance. However, the information you've requested regarding acceptance criteria, study details, and data provenance for typical AI/ML medical devices is not present in this document. This document is a 510(k) Summary for a traditional implantable medical device (spinal fixation system component), not an AI/ML diagnostic or prognostic device.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document reports mechanical test results, not clinical performance metrics like sensitivity, specificity, AUC, or Dice scores, which are typical for AI/ML devices.
- Sample size used for the test set and the data provenance: No test set of patient data is mentioned; the testing refers to mechanical integrity.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable to mechanical testing.
- Adjudication method for the test set: Not applicable to mechanical testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance (algorithm only without human-in-the-loop) was done: Not applicable as it's not an algorithm.
- The type of ground truth used: Not applicable as it's mechanical testing.
- The sample size for the training set: Not applicable as it's not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
What is present in the document is:
- Device Performance (Mechanical Testing Summary):
- Fatigue endurance limit: 353N
- Axial pull strength: 1086N
- Torsional grip strength: 1.95Nm
The document states, "Based on these results, the VERSALOK™ Screw Assembly should perform adequately when subjected to normal physiological loading." This implies that these mechanical performance metrics serve as the "acceptance criteria" for the device's physical integrity and functionality in a mechanical sense, rather than clinical efficacy as would be required for an AI/ML device.
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Image /page/0/Picture/2 description: The image shows a stylized letter "W" in black against a white background. The "W" is formed by two inverted triangles that are connected at their apexes. The right side of the "W" has a break in the triangle, creating a gap. There is a small circle with a dot in the center below the "W".
Contact Person: Judy English Date Prepared: September 8, 1996
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510(k) Summary
Trade Name:
Common Name:
Predicate Devices:
VERSALOK™ Screw Assembly. Product line addition to WRIGHTLOCK™ Posterior Spinal Fixation System Soondstolisthesis Spinal Fixation Device System WRIGHTLOCK™ Posterior Spinal Fixation System (Wright Medical Technology, Inc.) MOSS® Miami System (DePuy)
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
Description/intended Use The VERSALOK™ Screw Assembly is a polyaxial screw assembly consisting of screws, locking sleeves, and caps. The system is designed to accommodate the rods of the commercially available WRIGHTLOCK™ Posterior Spinal Fixation System (K950074-SE 08/11/95). The system features a low profile as well as a top loading design. It allows for up to 8mm offset from the rod and up to 30 degrees of angulation in all planes prior to final locking. The VERSALOK™ Screw Assembly is available in a range of sizes to fit varying anatomical requirements.
The VERSALOK™ Screw Assembly is supplied as an alternative component for use with the WRIGHTLOCK™ Postedor Spinal Fixation System to fix the spine for appropriate indications apply when used as a pedicle screw.
A WRIGHTLOCK™ construct with screws attached to the pedicies of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used for the treatment of severe spondylolisthesis (Grade 3) at the fith lumbar - first sacral (LS-S1) vertebral joint. The device is intended to be implanted using a posterior surgical approach and removed after development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the system are also indicated to provide temporary stability of the thoracic, thoracolumbar. or lumbar spino (T1 to S1) during bony fusion healing secondary to: (1) Unstable spinal fractures (such as fracture diskcations) or spinal tumors; (2) Degeneralive disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); (3) Spinal curvatures (such as idiopathic scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: progressive, despite other forms of treatment; detrimental to cardiopulmonary function; interfering with spinal mechanics or causing severe back pain; or cosmetically unacceptable, progressive, and painful.
Material. Components in the VERSALOK™ Screw Assembly are manufactured from stainless steel conforming to ASTM F 1314.
Summary of Technological Differences The VERSALOK™ Screw Assembly is a product line addition to the WRIGHTLOCK™ Posterior Spinal Fixation System and there are few differences between the devices. Both devices have the same intended use and are manufactured from the same material. They are different in that the VERSALOK™ Screw Assembly is a polyaxial screw option to the system that previously included only a monoaxial screw. In addition, the design of the VERSALOK™ Screw Assembly differs from the screw assembly of the MOSS® Miami System in minor design features and locking mechanism: however, the differences only address surgeon preferences and do not impact the function or negatively impact the safety of the device.
Testing Summary The VERSALOK™ Screw Assembly tested with the following mean results: faligue endurance limit of 353N, axial push strength of 1086N, and torsional grip strength of 1.95Nm. Based on these results, the VERSALOK™ Screw Assembly should perform adequately when subjected to normal physiological loading.
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