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The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.

The StaXx™ FX System is a vertebral fracture reduction device composed of a base wafer and stackable wafers fabricated from preformed Polyetheretherketone (PEEK-OPTIMA) with 6% Barium Sulfate (BaSO4). The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty (20) wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm).

The provided text describes a 510(k) submission for the "StaXx™ FX System," a device intended for reducing spinal fractures. The submission establishes substantial equivalence to a predicate device through mechanical testing. However, the document does not contain specific acceptance criteria, reported device performance data, details of a study demonstrating fulfillment of acceptance criteria, or most of the requested information about sample sizes, ground truth, or expert involvement.

The key statement regarding performance is: "In addition, mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use." This is a high-level summary and lacks the detailed information requested.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or directly stated from the document:

1. Table of acceptance criteria and the reported device performance:
   • The document only states that "mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use." No specific acceptance criteria (e.g., strength, durability thresholds) or detailed performance metrics (e.g., maximum load, fatigue life) are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document only mentions "mechanical testing."

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, as this was mechanical testing, not a clinical study involving human interpretation of data where "ground truth" would be established by experts in that context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (mechanical testing).

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 mechanical implant, not an AI or imaging diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This device is a mechanical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical expert-derived ground truth. For mechanical testing, the "ground truth" would be the engineering specifications and material properties against which the device's mechanical performance is measured.

8. The sample size for the training set: Not applicable. This is mechanical testing, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This is mechanical testing.

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The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.

The StaXx™ FX System is a vertebral fracture reduction device composed of stackable wafers fabricated from preformed PMMA. The System includes a base wafer fabricated from PEEK-OPTIMA with 6% Barium Sulfate. The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty-four wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm)

The provided text is a 510(k) summary for the StaXx™ FX System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria or a study proving the device meets them in the way described in the prompt's request for clinical performance metrics (e.g., sensitivity, specificity).

The document states:
"In addition, mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use. Any differences between the StaXx™ FX and the predicate devices do no affect the safety or effectiveness of this device."

This indicates that mechanical testing was performed to show the device meets performance requirements, but the specific acceptance criteria and the results of that testing are not detailed in this 510(k) summary. The summary focuses on comparing the new device to existing predicate devices to establish substantial equivalence based on intended use and mechanical properties, not on clinical performance metrics like accuracy, sensitivity, or specificity that would come from a study involving human readers or expert ground truth.

Therefore, I cannot provide the requested table or detailed information on specific acceptance criteria, sample sizes, expert ground truth, or reader studies because this information is not present in the provided text.

The requested information cannot be extracted from the provided text.

Ask a specific question about this device