Search Results

The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The StaXx® IB System is an intervertebral body fusion device composed of wafers that are stacked into an expandable implant to adjust the implant. The implant. The implants are to be used with autogenous bone graft material. The implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.

The document provided describes a 510(k) submission for the StaXx® IB System, an intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the same way a novel AI/software device would.

Therefore, many of the requested categories related to AI/software device performance studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to this 510(k) submission for a physical medical device.

Here's a breakdown of the relevant information provided and an explanation of why other sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are not defined as quantitative metrics of diagnostic performance (e.g., sensitivity, specificity) as they would be for an AI algorithm. Instead, the "acceptance criteria" are met by demonstrating substantial equivalence to predicate devices through mechanical performance testing.

• Static and dynamic axial compression (per ASTM F2077)
• Static and dynamic compression shear (per ASTM F2077)
• Subsidence (per ASTM F2267)
  Conclusion: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IB System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness." |
  | Material Biocompatibility | Materials must be safe for implantation. | The implant components are manufactured from PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate, which are known biocompatible materials widely used in spinal implants and present in predicate devices. The document implies their use aligns with predicates, ensuring known safety. |
  | Intended Use & Indications | Device must be suitable for its stated intended use and indications. | The intended use and indications for the StaXx® IB System are aligned with those of the predicate devices. The comparison table confirms "similarity in intended use, indications for use, materials and performance." |

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This is a physical intervertebral body fusion device, not a software or AI device that processes data for diagnostic purposes. The "test set" here refers to physical devices undergoing mechanical stress tests, not data samples. The document does not specify the number of devices tested, which is common for mechanical testing in 510(k) submissions where the focus is on meeting standard thresholds rather than statistical population inferences from data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a physical medical device. There is no "ground truth" established by human experts in the context of diagnostic data analysis. The "truth" is established by the physical testing results against recognized ASTM standards.

4. Adjudication Method for the Test Set

Not Applicable. See explanation in point 3.

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 applies to AI or image-based diagnostic devices. The StaXx® IB System is a physical implant.

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

Not Applicable. This applies to AI or software algorithms.

7. The Type of Ground Truth Used

Not Applicable. For mechanical testing, the "ground truth" is typically defined by the specified parameters and failure points outlined in the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267). The device's performance is measured against these engineering standards.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" for a physical medical device. This concept applies to machine learning algorithms.

9. How the Ground Truth for the Training Set was Established

Not Applicable. See explanation in point 8.

Ask a specific question about this device