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The CORRIDOR® Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle.

The CORRIDOR® Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies: degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.

The CORRIDOR® Fixation System is also indicated for fracture fixation of small bones and bone fragments including odontoid fractures.

The CORRIDOR® Fixation System consists of screws and instruments designed to aid in bone fixation. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. Screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

This document is a 510(k) summary for the CORRIDOR® Fixation System. It indicates that the purpose of the submission is to request clearance for additional indications for a device that was previously cleared (K083442). Therefore, it directly states that:

"No mechanical testing was completed for this submission as these devices are previously cleared."

This means the current submission does not include a new study to prove device performance against acceptance criteria because it is based on previously established performance of the same device and its predicates.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document focuses on demonstrating substantial equivalence for new indications rather than showcasing new performance data for the device itself.

However, I can provide the following based on the document:

1. Table of Acceptance Criteria and the Reported Device Performance: Not applicable. The document states, "No mechanical testing was completed for this submission as these devices are previously cleared." The basis for clearance is substantial equivalence to predicate devices, not new performance data.

2. Sample Size Used for the Test Set and the Data Provenance: Not applicable. No new performance study or test set was conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts: Not applicable. No new performance study or ground truth establishment was conducted for this submission.

4. Adjudication Method for the Test Set: Not applicable. No new performance study was conducted.

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: Not applicable. This device is a fixation system for spinal surgery and not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used: Not applicable. No new performance study was conducted. Previous clearances of the device and its predicates would have relied on a combination of engineering testing, clinical literature, and potentially clinical data to establish safety and effectiveness for their original indications.

8. The Sample Size for the Training Set: Not applicable. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established: Not applicable. This is not an AI/machine learning device.

The document primarily makes a case for substantial equivalence based on technological characteristics, performance, design, intended use, and material composition being similar to predicate devices, and that the materials used meet applicable standards or are already used in cleared devices (biocompatibility). It also mentions bacterial endotoxin testing was conducted in accordance with ANSI/AAMI ST-72:2011, which is a standard test for medical devices to ensure they are free from harmful levels of bacterial endotoxins. This, however, is a standard safety test, not a performance study to meet specific functional acceptance criteria related to efficacy for new indications.

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The CORRIDOR™ Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle.

The CORRIDOR™ Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the spine; instability and trauma including spinal fractures and/or dislocations.

The CORRIDOR™ Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. The CORRIDOR™ Fixation System screws are fabricated from medical grade titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic corrosion, titanium alloy implants should not be used in the same construct as stainless steel implants.

This document is a 510(k) summary for the Globus Medical Inc. CORRIDOR™ Fixation System, a spinal implant. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices based on similarities in indications, design, materials, and performance.

The provided text does not contain any information regarding the acceptance criteria for a device, a study proving the device meets those criteria, or any details about a study's methodology, sample sizes, expert involvement, ground truth, or statistical analysis.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document is solely a regulatory submission summary for substantial equivalence, not a scientific study report.

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