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The REVLOK™ Fenestrated Screw System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVLOK™ Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVLOK™ Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The REVLOK™ Fenestrated Screw System consists of monoaxial screws, uniplanar screws, polyaxial screws, dual-outer-diameter screws, reduction screws, rods and locking caps. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVLOK™ implants mate with 5.5mm diameter rods, and 6.35mm implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Locking caps are used to connect the screws to the rod.

The most common use of this screw and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws.

The most common use of this screw and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine.

The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67, F1537 and F138. All other REVLOK™ implants are manufactured from titanium alloy or stainless steel, as specified in ASTM F136, F1295, F138 and F67. The REVLOK™ Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

This is a 510(k) premarket notification for a medical device (Globus Medical, Inc.'s REVLOK™ Fenestrated Screw System), not an AI/ML device. Therefore, the provided information does not contain the specific acceptance criteria and study details outlined in your request.

The document discusses the substantial equivalence of the REVLOK™ Fenestrated Screw System to predicate devices based on mechanical testing, not clinical performance metrics related to AI or human reader improvement.

Here's why the requested information about AI/ML device acceptance criteria and studies cannot be extracted from this document:

• Device Type: The REVLOK™ Fenestrated Screw System is a spinal implant system (screws, rods, locking caps). It is a physical medical device, not a software algorithm or AI/ML diagnostic tool.
• Regulatory Pathway: A 510(k) submission generally demonstrates substantial equivalence to a legally marketed predicate device. This often involves comparing device design, materials, manufacturing processes, and performance (e.g., mechanical strength) to the predicate. It does not typically involve clinical studies with human readers, ground truth consensus, or AI performance metrics.
• Performance Data: The document states, "Mechanical testing (static and dynamic compression and static torsional) was conducted in accordance with ASTM F1717 and the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device." This refers to physical engineering tests, not AI-related performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer the questions about sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided 510(k) summary for this mechanical spinal implant system.

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is to add rod to rod connectors and lateral rod connectors to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

This document describes a 510(k) premarket notification for the Coral™ Spinal System by Theken Spine, LLC. It aims to add rod-to-rod and lateral rod connectors to an already approved system. The submission emphasizes substantial equivalence to existing predicate devices based on design, materials, indications for use, and manufacturing processes.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria. The document is a regulatory submission for a medical device that focuses on demonstrating substantial equivalence to previously approved devices, primarily through comparison of design, materials, and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The sections below will indicate that the information is not available in the provided document.

Acceptance Criteria and Device Performance Study Information

The provided document is a 510(k) summary for a medical device (Coral™ Spinal System) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results. Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Information Not Available in the Provided Text. The document does not describe specific acceptance criteria or report performance metrics for the Coral™ Spinal System beyond declaring it substantially equivalent to predicate devices.

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

• Information Not Available in the Provided Text. No test set, data provenance, or sample sizes related to a performance study are mentioned. The submission relies on design, material, and functional comparisons for substantial equivalence.

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

• Information Not Available in the Provided Text. The document does not describe a performance study involving ground truth establishment by experts.

4. Adjudication method for the test set

• Information Not Available in the Provided Text. No adjudication method for a test set is described.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system. Performance is assessed through mechanical testing and comparison to predicate devices, not through standalone algorithm performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Information Not Available in the Provided Text. No ground truth for a performance study is mentioned as no such study is detailed.

8. The sample size for the training set

• Information Not Available in the Provided Text. No training set is mentioned as the document is not describing a machine learning or AI-based device.

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

• Information Not Available in the Provided Text. No ground truth for a training set is mentioned.

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