Search Results

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.

Ask a specific question about this device

The SpineView 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 Spine View X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and 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 to accommodate varying anatomy. The primary difference between the previously cleared and the modified cage models is that the expansion of the upper plate is parallel to the bottom housing, whereas the previously cleared device expands at an angle. 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 Spine View 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 instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before use.

The provided text is a 510(k) premarket notification for the SpineView X-Pac Expandable Lumbar Cage System. It details the device's description, indications for use, and a comparison to a predicate device, focusing on mechanical testing performance data to demonstrate substantial equivalence.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to an AI/machine learning model's performance, human reader studies (MRMC), or a standalone algorithm performance. The acceptance criteria discussed in the document are limited to the mechanical performance of the physical device (e.g., static and dynamic compression, subsidence, expulsion) in accordance with FDA guidance and ASTM standards for intervertebral fusion devices.

Therefore, I cannot provide the requested information regarding AI model performance, expert ground truth, adjudication methods, or MRMC studies because this document pertains to a physical medical device and not a software as a medical device (SaMD) or an AI-enabled diagnostic tool.

The information I can extract, pertaining to the physical device's acceptance criteria and performance, is as follows:

1. Table of Acceptance Criteria (Mechanical Performance) and Reported Device Performance:

Note: The document states that these tests were conducted "to demonstrate substantial equivalence to the predicate," implying that the performance met the thresholds necessary for this claim. Specific numerical performance values are not provided in this summary.

Regarding the other requested information (2-9), it is not applicable to this document as it does not describe an AI/ML-based device or a clinical study for software performance:

• 2. Sample size used for the test set and the data provenance: Not applicable to this type of device (physical implant). Mechanical testing utilizes test samples of the device itself, not patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods.
• 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. This is for a physical implant, not an AI diagnostic tool.
• 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 concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the performance requirements of the ASTM standards and FDA guidance for intervertebral fusion devices (e.g., specific load capacities, displacement limits).
• 8. The sample size for the training set: Not applicable. There is no AI model or training set described.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission focuses on demonstrating the substantial equivalence of a physical medical device (SpineView X-Pac Expandable Lumbar Cage System) through mechanical performance testing, rather than the performance of an AI/machine learning algorithm.

Ask a specific question about this device

The SpineView 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 SpineView X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a caqe implant and 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 to accommodate varying anatomy and can expand to the desired lordosis. 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 SpineView X-Pac Expandable Lumbar Cage System implants are singleuse, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before use.

This document is a 510(k) premarket notification decision letter from the FDA regarding the SpineView X-Pac Expandable Lumbar Cage System. It does not describe an AI medical device or a study involving acceptance criteria for such a device.

The document discusses:

• The FDA's decision that the SpineView X-Pac Expandable Lumbar Cage System is substantially equivalent to a legally marketed predicate device.
• The regulatory classification and product code for the device.
• Indications for Use of the SpineView X-Pac Expandable Lumbar Cage System.
• A brief device description: an intervertebral body fusion device made of medical-grade titanium alloy, single-use, provided non-sterile, and intended to be cleaned and steam sterilized before use, with reusable instruments.
• A mention of mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) conducted in accordance with specific guidance documents and ASTM standards to demonstrate substantial equivalence to the predicate.

There is no mention of:

• Acceptance criteria in terms of AI/algorithm performance (e.g., sensitivity, specificity, AUC).
• A study proving a device meets such acceptance criteria.
• Sample sizes for test or training sets for an AI algorithm.
• Data provenance for AI models.
• Experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human reader improvement with AI.
• Standalone algorithm performance.
• How ground truth was established for training data.

Therefore, I cannot provide the requested information based on the provided text, as it pertains to a traditional medical device (an implantable cage system) and not an AI/software as a medical device (SaMD).

Ask a specific question about this device