(206 days)
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.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (from document) |
|---|---|
| Mechanical Equivalence: StaXx® XD System demonstrates comparable mechanical properties and safety profiles to the predicate device, StaXx® XD System (K052670). | "mechanical testing demonstrated that the StaXx® XD System is equivalent to its predicate device." |
| Technological Equivalence: Minor differences do not raise new questions of safety or effectiveness. | "The minor differences... do not raise any new questions of safety or effectiveness." |
| Intended Use Equivalence: Same indications for use as the predicate device. | The intended use description is consistent with typical vertebral body replacement devices. |
| Material Equivalence: Materials are biocompatible and safe (implied by predicate equivalence). | Composed of PEEK-OPTIMA with 6% Barium Sulfate (material of the implant components is specified). |
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.