Search Results

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

The Expanding Innovations X-Pac Expandable LLIF 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 radies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The X-Pac Expandable LLIF Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Expanding Innovations X-Pac Expandable LLIF 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 are placed via the lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable LLIF Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are reusable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

The provided text is a 510(k) summary for the X-Pac Expandable LLIF Cage System, which is a medical device for intervertebral body fusion procedures. It does not describe an AI/ML powered device or an algorithm. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's a summary of the relevant performance data mentioned:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The testing described is mechanical, not involving patient data.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable. The ground truth is based on engineering standards and mechanical test results, not expert interpretation of diagnostic images or clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The testing is mechanical and does not involve adjudication.

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

• MRMC Study: No, this is not an AI/ML device.

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

• Standalone Performance: No, this is not an AI/ML device.

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

• Ground Truth Type: Mechanical integrity and performance according to ASTM F2077 standards for intervertebral body fusion devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Ground Truth Establishment for Training Set: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion.

The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

The X-Pac Expandable Lumbar 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 are placed via the transforaminal approach. The device is available in different sizes and footprints, to accommodate varying patient anatomy, and is designed to allow for intraoperative adjustment in both the parallel and lordotic configurations. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295. The Expanding Innovations X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this Special 510(k).

The provided document is a 510(k) premarket notification for a medical device called the "X-Pac Expandable Lumbar Cage System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study for a novel device. Therefore, much of the requested information (like expert-established ground truth, MRMC studies, or standalone algorithm performance) is not typically part of this kind of submission and is not present in the provided text.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it states that the device successfully underwent performance testing and met the requirements outlined by recognized standards.

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

The document refers to mechanical testing of "new cage sizes." It does not specify a sample size (e.g., number of units tested) for these tests, nor does it refer to a "test set" in the context of patient data or clinical imaging. The testing is for the physical device, not an AI algorithm. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.

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

This information is not applicable and not provided. The testing relates to the mechanical properties of an implant, not to a diagnostic or interpretative task where expert ground truth would be established.

4. Adjudication method for the test set

This information is not applicable and not provided, as there is no "test set" requiring adjudication in the context of this device's mechanical evaluation.

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 such study was done or reported. This type of study is relevant for AI-powered diagnostic or assistive devices, which the X-Pac Expandable Lumbar Cage System is not.

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

This is not applicable as the device is a physical implant, not an algorithm.

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

The "ground truth" for the performance testing of this device would be defined by the specifications and expected performance defined by the relevant ASTM standards (ASTM F2077, ASTM F2267) and the predicate device's established performance. It's about meeting engineering and material science standards for an implant.

8. The sample size for the training set

This is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This is not applicable, as there is no training set for this device.

Ask a specific question about this device