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The Rod-To-Rod Coupler is intended to form a transverse connection between spinal rods in a spinal construct in order to increase the torsional stiffness of the construct.

A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.

When not used as a pedicle screw fixation system, various combinations of the Versalok Posterior Spinal Fixation System components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:

• 1. Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
• 2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by history and radiographic studies);
  • 3. Spinal curvatures (such as idiopathic scoliosis, neuromuscular 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 system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.

The coupler is designed to form a transverse connection between spinal construct in order to increase the torsional stiffness of the construct.

The provided text describes a 510(k) premarket notification for a medical device, the Rod-To-Rod Coupler, which is part of the Versalok Posterior Spinal Fixation System. However, it does not contain explicit acceptance criteria or detailed study results in the format usually associated with a scientific study proving device performance against such criteria.

The "Testing Summary" section states: "Submitted testing demonstrates that the Rod-To-Rod Coupler fatigue performance is comparable to a predicate device and adequate for its intended use." This is a high-level summary, not a detailed report of acceptance criteria and performance data.

Therefore, many of the requested details cannot be extracted from the provided text. I will answer based on the information that is available.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document states "Submitted testing demonstrates...", suggesting a test was conducted, but details on sample size and data provenance are absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The testing described is mechanical fatigue performance, not a clinical study requiring expert ground truth for interpretation of cases.

4. Adjudication Method

Not applicable, as it's a mechanical test, not a subjective clinical assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The testing described is mechanical (fatigue performance).

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This is a physical medical device, not an AI algorithm. The performance testing would be of the device itself.

7. Type of Ground Truth Used

The "ground truth" for the mechanical fatigue testing would be the physical properties and performance of the device under specific test conditions, likely compared against a predicate device's known performance standards or established engineering benchmarks for spinal implants. The document implies a comparison to a "predicate device."

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study that would have a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable.

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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:

1. 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.
2. 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.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable to mechanical testing.
4. Adjudication method for the test set: Not applicable to mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (algorithm only without human-in-the-loop) was done: Not applicable as it's not an algorithm.
7. The type of ground truth used: Not applicable as it's mechanical testing.
8. The sample size for the training set: Not applicable as it's not an AI/ML model.
9. 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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