Search Results

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markers for additional visualization under fluoroscopy. The system also includes the Surgical Gun, a delivery device to place and expand the system.

The provided document is a 510(k) summary for the StaXx® XD System, which is a vertebral body replacement device. This summary describes the device and its intended use, but it does not contain information related to software or AI performance, nor does it present "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of device performance metrics often associated with AI/software-based medical devices (e.g., sensitivity, specificity, accuracy).

Instead, the "Performance Data" section (Section 8) indicates that the device's substantial equivalence to a predicate device was demonstrated through:

• Dynamic axial compression testing according to ASTM F2077.

This type of testing is a standard mechanical engineering test for spinal implants to assess their structural integrity and performance under simulated physiological loads. Therefore, the "acceptance criteria" and "device performance" would relate to the results of these physical tests, compared against the predicate device or established standards.

Given the nature of the document, the following requested information cannot be fully provided, as it pertains to AI/software performance studies which are not relevant to this submission:

1. A table of acceptance criteria and the reported device performance: This would be specific to the mechanical testing (e.g., yield strength, stiffness, fatigue life). The document states "Dynamic axial compression testing according to ASTM F2077 was performed to demonstrate that the modified StaXx® XD System is substantially equivalent to the predicate StaXx® XD System." The specific numerical acceptance criteria and reported device performance values from this testing are not included in the provided summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device subject to mechanical testing, not a dataset for software evaluation.
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): 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): The "ground truth" for a mechanical device is its physical properties and measured performance against engineering standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided submission is for a physical medical device (vertebral body replacement) and focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not through AI/software performance evaluation.

Ask a specific question about this device

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.

The purpose of this submission is to gain clearance for the addition of tantalum markers to the implants for added visualization under fluoroscopy.

The provided text describes a 510(k) submission for the Spine Wave StaXx® XD System, a vertebral body replacement device. The assessment of acceptance criteria and device performance is based on mechanical testing rather than a clinical study involving human patients or imaging analysis.

Here's a breakdown of the requested information 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

The study described is mechanical testing, not a test set involving human data. Therefore:

• Sample size: Not applicable in the context of human or imaging data. It would refer to the number of physical devices tested. The specific number of devices tested mechanically is not provided in the text; it only states "mechanical testing" was performed.
• Data provenance: Not applicable in the context of human or imaging data. It's mechanical test data from product testing.

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 established by engineering standards (ASTM F 2077) and the physical properties of the device, not by expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. This concept applies to the interpretation of clinical or imaging data, not mechanical testing against engineering standards.

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, and the submission is for the addition of tantalum markers for visualization under fluoroscopy, not an AI-powered diagnostic tool. The assessment is purely mechanical.

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

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

7. The type of ground truth used

For the mechanical testing, the "ground truth" is defined by the acceptance criteria specified in ASTM F 2077 for dynamic axial compression and dynamic torsion, which are established engineering standards for spinal implant testing.

8. The sample size for the training set

Not applicable. There is no training set mentioned or implied as this is not a machine learning or AI-driven device.

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

Not applicable. There is no training set involved. The evaluation of this device is based on compliance with established mechanical testing standards.

Ask a specific question about this device

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

The StaXx® XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the implant. The device is offered in sizes ranging from 7mm to 30mm.

This document describes the StaXx® XD System, a vertebral body replacement device. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert qualifications, and human-in-the-loop performance are not available in the provided document.

However, I can extract and infer some information based on the typical 510(k) pathway for devices like this.

Here’s a breakdown based on the provided text and general knowledge of 510(k) clearances:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in the provided document. For 510(k) devices, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This is typically achieved through comparative evaluation of technological characteristics, materials, and mechanical testing results.
• Reported Device Performance: The document states: "In addition, mechanical testing demonstrated that the StaXx® XD System is equivalent to its predicate device. The minor differences between the StaXx® XD System and the predicate device do not raise any new questions of safety or effectiveness." This statement serves as the reported performance relative to the predicate.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no mention of a clinical "test set" in the sense of patient data used to evaluate AI performance. The equivalence was based on mechanical testing and comparison of device characteristics.
• Data Provenance: Not applicable. The "data" referenced is mechanical testing data, not patient data from a specific country or collected retrospectively/prospectively.

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

• Number of Experts: Not applicable. As there was no clinical test set for AI performance, there were no experts establishing ground truth in this context.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: 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

• MRMC Study: No. This is a medical device (spinal implant), not an AI diagnostic/imaging device that would typically involve human readers.

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

• Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: For the mechanical testing, the "ground truth" would be the established engineering standards, material properties, and performance benchmarks of the predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI model that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

Ask a specific question about this device

The StaXx™ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.

The StaXxTM XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the system. The device is offered in sizes ranging from 7mm to 30mm.

This document is a 510(k) summary for the StaXx™ XD System, a vertebral body replacement device. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and a comparison of intended use, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not applicable or cannot be extracted from this document.

However, I can provide the available information:

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

Based on the document, the primary "acceptance criterion" presented implicitly is the device's ability to meet "performance requirements for its intended use" through mechanical testing, demonstrating its substantial equivalence to predicate devices. Specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this 510(k) summary, as it's for a hardware medical device rather than an AI/software device.

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

The document does not describe a clinical "test set" in the context of diagnostic performance or AI model evaluation. The "testing" mentioned is mechanical testing. Therefore, sample size and data provenance in this context are not applicable.

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

Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on clinical diagnoses) is not relevant to this 510(k) summary for a hardware implant.

4. Adjudication method for the test set

Not applicable. There is no clinical test set described that would require an adjudication method.

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 document describes a medical device (spinal implant), not an AI-assisted diagnostic tool.

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

Not applicable. This document is not about an algorithm or software. It describes a physical spinal implant.

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

For the mechanical testing mentioned, the "ground truth" would implicitly be relevant engineering standards and biomechanical properties required for spinal implants. This is not explicitly detailed in the document beyond stating that the device "meets the performance requirements."

8. The sample size for the training set

Not applicable. There is no AI model or "training set" described in this document.

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

Not applicable. There is no AI model or "training set" described in this document.

Ask a specific question about this device