Search Results

When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six mon-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.

When used as a Vertebral Body Replacement device, the XY cor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.

The XY cor Expandable Spinal Spacer System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using Alphatec Spine instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. These implants are intended for use with supplemental spinal fixation and bone graft.

This document is a 510(k) premarket notification for a medical device called the "XYcor® Expandable Spinal Spacer System." It is a regulatory submission to the FDA (Food and Drug Administration) for clearance to market the device. The document does not contain acceptance criteria for the device based on a clinical study or performance data that would typically be described with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices, which is the primary requirement for a 510(k) submission. This means the device is shown to be as safe and effective as a legally marketed device, rather than proving its effectiveness through a new clinical trial with pre-defined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy).
2. Sample size, data provenance, number of experts for ground truth, adjudication method, or MRMC study details for a clinical study with acceptance criteria.
3. Standalone performance, type of ground truth, or training set details for an algorithm, as this is a physical medical device, not an AI/algorithm-based diagnostic or prognostic tool.

What the document does describe in terms of "studies" and "performance":

The document mentions several types of studies performed, but these are for demonstrating the device's physical properties, biocompatibility, and surgical technique, not clinical efficacy in the way you're asking.

• Animal study: "An animal study was performed to evaluate fusion in a sheep model."
  • Purpose: To evaluate spinal fusion (a biological outcome in an animal model).
  • Acceptance criteria: Not specified in this document. These would likely be histological or radiographic evidence of fusion.
  • Reported performance: Not specified in this document, beyond the fact that it was performed.
• Cadaver study: "A cadaver study was performed to validate the surgical technique and implantation of this device for the interbody cage indications."
  • Purpose: To validate surgical technique and device implantation.
  • Acceptance criteria: Not specified, but would likely relate to successful implantation, stability, and ease of use.
  • Reported performance: Not specified.
• Mechanical testing: "Mechanical testing was performed to demonstrate acceptable performance characteristics and substantial equivalence." This is the most detailed "performance" section.
  • Types of tests performed (ASTM standards):
    • ASTM F2077: Static Axial Compression, Static Compressive Shear, Static Torsion, Cyclical Axial Compression, Cyclical Compressive Shear, Cyclical Torsion Testing
    • ASTM F266: Static Subsidence
    • ASTM Draft Standard F-04.25.02.02: Static Expulsion, Lateral and Flexion Extension Bending, Subsidence
  • Acceptance criteria: For substantial equivalence, the performance in these mechanical tests would need to be comparable to or better than the predicate devices. Specific quantitative acceptance criteria (e.g., minimum load to failure, maximum deformation) are not detailed in this summary but would be part of the full submission.
  • Reported performance: The document states that these tests were performed to "demonstrate acceptable performance characteristics and substantial equivalence," implying the device met the necessary mechanical benchmarks to be considered equivalent to the predicate devices. Quantitative results are not provided in this summary.

Summary of available information related to your request:

• Animal study: "a sheep model" – sample size not specified.
• Cadaver study: Sample size not specified.
• Mechanical testing: Performed on device samples; "sample size" is not typical for these tests but refers to the number of units tested per standard. Details not provided. |
  | 3. Number of experts & Qualifications | Not applicable. This relates to physical device testing and surgical validation, not expert-based ground truth for clinical decision-making. |
  | 4. Adjudication method | Not applicable. |
  | 5. MRMC comparative effectiveness study | No. This is a physical orthopedic implant, not an AI/algorithm for diagnostic imaging or a human-in-the-loop system in that context. |
  | 6. Standalone performance | Not applicable for an algorithm. The mechanical testing assesses the "standalone" structural performance of the device in a lab setting. |
  | 7. Type of ground truth | Not applicable in the AI/clinical data sense.
• Animal study: Fusion (histological/radiographic evidence).
• Cadaver study: Successful surgical technique and implantation.
• Mechanical testing: Engineering specifications and ASTM standards (e.g., load-bearing capacity, fatigue life) compared against predicate device performance. |
  | 8. Sample size for training set | Not applicable. This document is for a physical medical device, not an algorithm that requires a training set. |
  | 9. How training ground truth established | Not applicable. |

In essence, this document is a regulatory submission asserting that a new medical device is safe and effective because it is fundamentally similar to existing, legally marketed devices, backed by engineering and biocompatibility testing, rather than presenting new clinical acceptance criteria or performance derived from a large-scale clinical trial.

Ask a specific question about this device