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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.

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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.

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X-PAC® N-GAGE™ 2-Hole and 4-Hole Lumbar Plate System is indicated for temporary stabilization during spinal fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients for the treatment of degenerative disc disease (DDD), spondylolisthesis, spondylolysis, spinal stenosis, pseudoarthrosis, deformity (defined as scoliosis, kyphosis, or lordosis), tumors, trauma (i.e. fractures including dislocation and subluxation), and/or failed previous fusion. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

N-GAGE™ 2-Hole and 4-Hole Plates may be assembled with the X-PAC® LLIF Expandable Cage to create a plate-spacer assembly. When assembled to the X-PAC® LLIF Expandable Cage, the plate-spacer assembly is indicated for standalone use at one or two levels of the lumbosacral spine (L2-S1), as an adjunct to fusion in skeletally mature patient with degenerative disc disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by 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 to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have at least six (6) months of non-operative treatment.

N-GAGE™ 1-Hole Plate is to be assembled with the X-PAC® LLIF Expandable Cages. When assembled, the system is intended to maintain the relative position of X-PAC® LLIF Expandable Cage and intended for use with supplemental fixation (e.g., posterior spinal systems).

X-PAC® N-GAGE™ Lumbar Plate System is a lumbar plate system comprised of implants (plates and screws), couplers, and surgical instruments. The implants are used in a lateral approach interbody fusion and are designed to provide rigid stabilization and support to the spinal column. The plate helps to restrict movement between adjacent vertebrae, preventing further injury and promoting the fusion of the bones over time. During operation, the plate is positioned laterally or anterolaterally, following insertion of a spinal interbody fusion spacer, via a removable inserter and screwdriver. The plate system can be installed either attached to (with a coupler) or floating from the X-PAC® LLIF Cage. The plates are available in multiple sizes and configurations to accommodate all heights of interbody spacing. The plates have a flat, elongated shape that conforms to the curvature of the spine at the required level(s) and have holes to secure the plate to the vertebrae. The fully threaded screws are available in two diameters and multiple lengths to accommodate varying anatomies. The screws are inserted into the vertebral body to hold the plate in place. The system includes a 1-hole, 2-hole, and 4-hole configuration. The screw can be angled up to 20 degrees away from the cage, and 10 degrees towards the cage. Each screw hole has an adjacent tab, which is turned and locked over the screw head once the screw has been inserted. The coupler is used to create a secure connection between the plate and the interbody device. The plates, screws, tabs, and couplers are manufactured from medical grade titanium alloy per ASTM F136.

This document is a 510(k) clearance letter for a medical device called the X-PAC® N-GAGE™ Lumbar Plate System. It is not an AI/ML device, and therefore the request to describe acceptance criteria and associated studies for such a device is not applicable.

The document describes a physical medical implant (a lumbar plate system) and details the non-clinical mechanical tests performed to ensure its safety and effectiveness. It does not mention any artificial intelligence or machine learning components, nor does it refer to acceptance criteria that would typically be associated with AI/ML device performance (e.g., accuracy, sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as the provided document does not pertain to an AI/ML device.

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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.

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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 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 Expanding Innovations 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. The device is available in various sizes and footprints to accommodate varying 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 F1472. 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.

I am sorry, but the provided text from the FDA 510(k) K222797 submission for the "X-Pac Expandable Lumbar Cage System" does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or diagnostic algorithm.

The document is a traditional 510(k) for a medical device (an intervertebral body fusion device) that focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and performance within the context of mechanical and biological functionality, not algorithmic performance or diagnostic accuracy.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for an AI or diagnostic algorithm's performance.
2. Sample sizes used for the test set and the data provenance: Not applicable as there's no AI/diagnostic study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 5, H. Technological Comparison, I. Performance Data) states:

"A risk assessment was conducted to confirm that the modification to the Indications for Use Statement does not introduce new issues of safety or effectiveness."

This refers to a standard risk assessment for mechanical devices, not data-driven performance metrics for an AI/diagnostic system.

In summary, the provided document relates to a physical implantable medical device, not a software device or AI-powered diagnostic tool, and therefore does not contain the information you are requesting about acceptance criteria and performance studies for an algorithmic 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 Expanding Innovations 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 various sizes and footprints to accommodate varying 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 F1472. 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 surqical instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this Special 510(k).

This document describes the X-Pac Expandable Lumbar Cage System, an intervertebral body fusion device. The focus of the provided text is on demonstrating substantial equivalence to previously cleared devices rather than a de novo clinical study with specific acceptance criteria for performance.

Therefore, the information regarding acceptance criteria and performance is primarily concerned with mechanical testing to show the continued safety and effectiveness of new cage sizes, rather than a clinical study evaluating diagnostic accuracy or efficacy against specific clinical endpoints.

Here's a breakdown based on the provided text:

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

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

• Sample size: Not explicitly stated; however, "new cage sizes" implies a set of different configurations were tested.
• Data provenance: Not explicitly stated, but the testing was conducted in-house by Expanding Innovations, Inc. (or a contracted lab) as part of their risk assessment. This is not patient data but rather engineering test data.

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" here is based on engineering standards (ASTM F2077) and the performance of a predicate device, not on expert clinical interpretation of patient data.

4. Adjudication method for the test set:

• Not applicable. This was mechanical testing against a standard, not a clinical trial requiring adjudication of patient outcomes or expert consensus.

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 surgical implant (lumbar cage), not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This is a medical device (implant), not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the mechanical testing was defined by the performance requirements of ASTM F2077 and comparison to a legally marketed predicate device (K152539, K160856, K201145, and K203802). The goal was to show that the new sizes of the device performed equivalently to the predicate and met the established mechanical standards.

8. The sample size for the training set:

• Not applicable. This refers to mechanical testing of physical device variations, not a machine learning model with a training set.

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

• Not applicable. As above, this is mechanical testing, not a machine learning study.

Summary from the document:

The core of this 510(k) submission is to demonstrate substantial equivalence of new cage sizes for the X-Pac Expandable Lumbar Cage System to previously cleared versions (predicates). The primary evidence provided is a risk assessment, including mechanical testing, which confirmed that the new cage sizes do not introduce new issues of safety or effectiveness. This testing was performed in accordance with ASTM F2077 for compression and compressive shear. The results indicated that the new device sizes performed equivalently to the predicate devices. There is no mention of a human-in-the-loop study, a multi-reader multi-case study, or an AI algorithm’s performance.

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 Expanding Innovations 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 various sizes and footprints to accommodate varying 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 F1472. 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 nonsterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this traditional 510(k).

This document describes a 510(k) premarket notification for the "X-Pac Expandable Lumbar Cage System" and states that the device is substantially equivalent to previously cleared predicate devices. The focus of this submission is on the addition of new cage sizes.

Based on the provided text, there is no information present regarding a study that proves the device meets specific acceptance criteria based on AI/ML performance. The document is a traditional 510(k) summary for a physical medical device (an intervertebral body fusion device) and discusses mechanical testing to confirm the safety and effectiveness of new cage sizes, not AI/ML performance.

Therefore, I cannot fulfill the request for information regarding AI/ML acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not addressed in this filing.

The document focuses on:

• Device Type: Intervertebral body fusion device (physical implant).
• Purpose of Submission: Addition of new cage sizes to an existing cleared device.
• Performance Data: Mechanical testing (ASTM F2077, ASTM F2267, expulsion testing) to demonstrate substantial equivalence to predicate devices for the new sizes. This is not related to AI/ML performance.
• Ground Truth: For a physical device like this, "ground truth" would relate to mechanical properties, biocompatibility, and clinical outcomes, which are assessed through engineering tests and regulatory pathways (like 510(k) and post-market surveillance), not typically through expert consensus on image interpretation or pathology in the context of an AI/ML model.

If the request was based on the assumption that this document detailed an AI/ML device, that assumption is incorrect for this particular FDA filing.

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.

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