Search Results

The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with tantalum markers manufactured from EVONIK PEEK as described in MAF-1922 with the submissions of the predicate Cortina [MAX] (K171914 and K180431) or medical grade titanium per ASTM F136 with a TECOTEX® surface coating. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies. This submission is intended to add the titanium implants and expand the size offering to include larger footprints.

1. Acceptance criteria and reported device performance

The document does not explicitly state numerical acceptance criteria for device performance. Instead, it argues that the new device, the Cortina™ [MAX] Lumbar Cage System made from titanium, requires no additional testing because it is identical in form, shape, and function to previously cleared PEEK devices (K171914/K180431). The rationale given is that titanium material produces implants with a higher yield load and stiffness when the shape is identical.

Similarly, for the PEEK devices, the document states that the addition of longer PLIF implants (36-42 mm) does not create a new mechanical worst-case compared to the previously tested 20x9x7mm PLIF (K171914/K180431), thus no additional testing is required for the additional length in the line extension.

The DLIF implants also do not need to be tested as a new worst-case because their design and footprint do not represent a new worst-case for either static or dynamic mechanical testing, and the smallest DLIF is significantly larger than what was previously tested.

Therefore, the reported "device performance" in this context is that the new iterations of the device (titanium material and expanded PEEK sizes) are expected to perform equivalently or better than the previously cleared predicate devices for which performance was established, without the need for new mechanical testing to demonstrate this equivalence.

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

No new test set was used for this submission. The device's substantial equivalence is based on comparisons to previously cleared predicate devices. Therefore, there is no new data provenance to report beyond what would have been established for the predicate devices.

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

Not applicable. As no new test set was directly used for this submission, no new ground truth was established by experts for this specific 510(k). The equivalence is based on technical characteristics and previous clearances.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was performed for this 510(k) submission.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC comparative effectiveness study was done. This submission focuses on substantial equivalence based on material and size modifications to an existing device, rather than a comparative effectiveness study involving human readers and AI.

6. Standalone (algorithm only without human-in-the-loop performance) study

Not applicable. This device is an intervertebral body fusion device (physical implant), not a software algorithm or AI device.

7. Type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" relies on the established performance and safety of the predicate devices (Cortina™ [MAX] Lumbar Cage System - PEEK version, K171914/K180431, and other referenced devices). This would have been established through a combination of mechanical testing, material characterization, and potentially clinical data (if required for the predicates) to demonstrate their safety and effectiveness.

8. Sample size for the training set

Not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.

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

Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

Ask a specific question about this device

The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 lo S 1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confim1ed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides a general statement that the device's strength is sufficient and substantially equivalent to predicate devices, rather than specific numerical performance metrics against pre-defined acceptance criteria. The acceptance criteria are referenced implicitly by stating adherence to ASTM standards.

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

The document describes non-clinical performance testing of mechanical properties. It does not refer to a "test set" in the context of patient data or clinical studies. Therefore, information regarding sample size for a test set, country of origin, or retrospective/prospective nature is not applicable to this submission, as it focuses on device characteristics, not clinical performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical mechanical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical medical implant (lumbar cage system), not an algorithm or an AI-powered system.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this document is established through physical testing against recognized mechanical engineering standards (ASTM standards). The document states that the testing validates the "strength" of the device.

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device and its mechanical testing, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as above.

Summary of the Study:

The provided document (K180431) describes a 510(k) premarket notification for the Cortina™ [MAX] Lumbar Cage System. The submission is primarily for a name change from the Cortina™ (K171914) to Cortina™ [MAX], with no changes to the device itself.

The "study" referenced in the document is a series of non-clinical performance tests designed to assess the mechanical strength and stability of the lumbar cage system. These tests were conducted according to established ASTM standards:

• Static axial compression per ASTM F2077-11
• Dynamic axial compression per ASTM F2077-11
• Static subsidence per ASTM F2267-04
• Static expulsion per ASTM DRAFT F-04.25.02.02

The acceptance criteria for these tests are implicitly the requirements of the respective ASTM standards for intervertebral body fusion devices. The reported device performance is a qualitative statement that "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This document does not describe a clinical study, an AI/algorithm-based device, or a study involving human readers or patient data for performance evaluation. It is solely focused on demonstrating the physical and mechanical equivalence of the device to its predicate through engineering testing.

Ask a specific question about this device