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The StaXx® XD System is a vertebral body replacement device 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 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.

Device Description

The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are to be used with autograft or allograft and supplemental spinal fixation. The implants are manufactured from PEEK-OPTIMA with 6% Barium Sulfate, tantalum markers (ASTM F560), and a plasma-sprayed commercially pure titanium coating (ASTM F1580). The implants are available in a variety of shapes and sizes, to accommodate variations in anatomy. The system also includes a delivery device to both implant and expand the implant.

AI/ML Overview

The provided text describes a medical device, the StaXx® XD System, and its 510(k) submission to the FDA. The submission's purpose is to gain clearance for adding a commercially pure titanium coating to the device. However, the document does not contain information about acceptance criteria, study methodologies (like sample size for test sets or training sets, data provenance, expert qualifications, or adjudication methods), or any comparative effectiveness studies involving human readers or standalone algorithm performance. The document focuses on regulatory approval based on substantial equivalence to predicate devices, supported by non-clinical performance testing of the device's materials and mechanical properties.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes for test set, data provenance, number of experts for ground truth, adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm only) performance details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This information is typically found in clinical study reports or detailed engineering reports, which are not part of this FDA 510(k) summary document. The non-clinical performance testing mentioned relates to the physical and mechanical properties of the device and its titanium coating, not its diagnostic or clinical efficacy in the context of AI or imaging.

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K Number

K111418

Device Name

STAXX(R) XD SYSTEM

Manufacturer

SPINE WAVE, INC.

Date Cleared

2011-12-13

(207 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K101288,K102682

Intended Use

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.

Device Description

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.

AI/ML Overview

The provided 510(k) summary for the StaXx® XD System does not describe a study involving an AI/Machine Learning device or any software that processes diagnostic images. Instead, it describes a medical implant (vertebral body replacement) and its mechanical performance evaluation.

Therefore, many of the requested points related to acceptance criteria, ground truth, expert review, sample sizes for training/test sets, and MRMC studies, which are standard for AI/ML device descriptions, are not applicable to this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Mechanical Performance	Substantial equivalence in mechanical performance to predicate devices for additional sizes.	Finite Element Analysis (FEA) was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate devices. The submission concludes "does not present any new issues of safety or effectiveness."
Material Composition	Use of specified materials (PEEK-OPTIMA with Barium Sulfate, tantalum markers).	Device is composed of wafers manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contains tantalum markers for visualization. This is consistent with predicate materials.
Intended Use	Consistency with predicate device's intended use.	The intended use for the expanded StaXx® XD System is consistent with the predicate device: vertebral body replacement in the thoracolumbar spine (T1-L5) for tumor or trauma, to be placed bilaterally with autograft/allograft and supplemental fixation.
Design Characteristics	Wafers stacked into an expandable implant for height adjustment.	The system design (stacked wafers for expansion) is consistent with the predicate (K101288, K102682).

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

Not applicable. This is a mechanical device, not an AI/ML diagnostic tool. Performance was demonstrated through Finite Element Analysis (FEA), a computational simulation method, rather than a clinical test set with data provenance in the context of AI/ML.

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 performance from FEA typically involves engineering standards and simulation validity, not expert medical consensus on a diagnostic outcome.

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

Not applicable. This concept applies to human expert review in diagnostic studies, not mechanical testing or FEA.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for the mechanical performance of this device would be based on established engineering principles, material properties, biomechanical standards, and validated simulation models used in Finite Element Analysis. This is not a biological or diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set." Finite Element Analysis involves creating a model and performing simulations, not training on data.

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

Not applicable. As above, there is no training set for this type of device submission.