Search Results

X-PAC® LLIF Expandable Lateral Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

X-PAC® LLIF Expandable Lateral Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy, and the devices that are the subject of this 510(k) are placed via a lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy and is designed to allow for intraoperative adjustment in the height of the cage. Surfaces of the upper plate and bottom housing that contact the vertebral endplates are "toothed" to provide stability within the intervertebral space. The outer surface teeth are designed to resist expulsion in all directions. The fenestrated cage contains openings to enhance bony ingrowth and has a bulleted nose for easier entry into the disc space. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. X-PAC® LLIF Expandable Lateral Cage System implants are single-use, provided non-sterile, and are intended to be steam sterilized before use. The surgical instruments are designed to facilitate precise placement of the device within the intervertebral disc body, and are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

Here's an analysis of the provided FDA 510(k) clearance letter and submission summary for the X-PAC® LLIF Expandable Lateral Cage System, focusing on acceptance criteria and supporting studies, presented in the requested format:

Important Note: The provided document is a 510(k) clearance letter and accompanying summary. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical trials or extensive standalone performance studies in the way a PMA (Pre-Market Approval) might. Therefore, many of the requested details regarding human reader studies, expert qualifications for ground truth, and comprehensive clinical data are not typically found or required in a 510(k) for a device like an intervertebral cage system. The information below reflects what is available in the provided text.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The provided document describes non-clinical mechanical testing based on recognized standards. It does not refer to a "test set" in the context of patient data or algorithm performance.

• Sample Size for Test Set: Not applicable, as this was mechanical testing of the device, not a data-driven study on patient data.
• Data Provenance: Not applicable. The testing was conducted in a laboratory setting per ASTM standards.

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

Not applicable. The "ground truth" for mechanical testing is established by adherence to the specified parameters and methodologies defined in the ASTM standards (e.g., force application, displacement measurement, wear rates). No human experts were involved in establishing "ground truth" for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. This was mechanical testing following standardized protocols, not a study requiring adjudication of expert interpretations.

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

No. An MRMC comparative effectiveness study is not mentioned or applicable to this device, which is an intervertebral cage system. This type of study is more common for diagnostic AI software.

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

No. This device is a physical medical implant, not an algorithm or AI software. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by the established parameters and methodologies of the ASTM F2077-22 and ASTM F2267 standards. These standards define acceptable performance limits for mechanical properties (e.g., strength, durability, resistance to wear and expulsion) for intervertebral body fusion devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant and does not involve AI or algorithms that require a "training set."

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 one.

Ask a specific question about this device

X-PAC® TLIF Expandable Posterior Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® TLIF Expandable Posterior Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

X-PAC® LLIF Expandable Lateral Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System are lumbar interbody fusion systems comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via a transforaminal or lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy and is designed to allow for intraoperative adjustment in the height of the cage. Surfaces of the upper plate and bottom housing that contact the vertebral endplates are "toothed" to provide stability within the intervertebral space. The outer surface teeth are designed to resist expulsion in all directions. The fenestrated cage contains openings to enhance bony ingrowth and has a bulleted nose for easier entry into the disc space. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System implants are single-use, provided non-sterile, and are intended to be steam sterilized before use. The surgical instruments are designed to facilitate precise placement of the device within the intervertebral disc body, and are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I describe a study that proves the device meets specific acceptance criteria.

Here's why:

1. Nature of the Document: The provided text is a 510(k) Clearance Letter and 510(k) Summary. These documents primarily focus on demonstrating substantial equivalence to a previously cleared predicate device. They are not designed to present detailed performance data against pre-defined acceptance criteria in the way one would see in a clinical trial report or a performance validation study for a novel device, especially not for sophisticated AI/ML software.

2. Device Type: The device described in the document is an "Intervertebral Body Fusion Device" – specifically, an expandable posterior and lateral cage system. This is a mechanical implant, not a diagnostic AI device or software that would have performance metrics like sensitivity, specificity, or reader improvement.

3. Lack of AI/ML Component: There is no mention of artificial intelligence, machine learning, image analysis, or any software-based diagnostic component in this 510(k) submission. Therefore, questions 2 through 9 regarding test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment are not applicable.

Summary based on the provided text:

• Acceptance Criteria & Performance: Not present in the document because this is a mechanical device demonstrating substantial equivalence, not a performance study for an AI/ML diagnostic.
• Sample Size (Test Set): Not applicable. The submission relies on existing testing data for the predicate devices, not a new test set for AI performance.
• Data Provenance: Not applicable.
• Number of Experts/Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of Ground Truth: Not applicable.
• Sample Size (Training Set): Not applicable.
• Ground Truth Establishment (Training Set): Not applicable.

The submission states that:

• "The purpose of this submission is to expand the indications for use of X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System devices to include use of allograft and bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion."
• "Because the subject device is identical to the previously cleared primary predicate devices (K22374, K222797), it was determined that existing testing data is adequate to support the expanded indications proposed in the current submission."
• "The X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System are substantially equivalent to legally marketed predicates with respect to indications, design, materials, function, operation, and performance."

This indicates that the clearance was based on substantial equivalence to existing, previously cleared devices, making the detailed testing methodology for AI/ML performance questions irrelevant for this specific 510(k) submission.

Ask a specific question about this device