(63 days)
The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is 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 system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone.
The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy.
The provided text describes a medical device, the Pioneer Vertebral Spacer, and its regulatory clearance (K043206) in 2005. The information focuses on the device's description, intended use, classification, and substantial equivalence to a predicate device, rather than performance studies with quantitative acceptance criteria typically associated with AI/ML devices. Therefore, a direct answer to all points of your request for acceptance criteria and study details pertaining to AI/ML performance is not possible as this document does not contain that information.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device. Instead, it states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical and Chemical information presented. | "Mechanical and Chemical information were presented." (No specific values or thresholds are provided in this summary.) |
| Substantial equivalence to predicate devices (EBI CAS Spine Spacer System K042268) in terms of design, indications, performance, and materials. | The device was cleared based on its substantial equivalence to the predicate device, implying it met the same general performance expectations as the predicate for its intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a physical medical implant device, not an AI/ML system that would typically have a "test set" of data. The clearance is based on mechanical and chemical properties, as well as comparison to a predicate device.
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 an AI/ML model for diagnostic or classification tasks is not relevant here. The "ground true" for this device would be its mechanical and material properties as validated through engineering tests and its clinical effectiveness as observed in surgical use, which is not detailed in this summary.
4. Adjudication method for the test set
Not applicable. As there is no test set for an AI/ML model, there is no adjudication method.
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 surgical implant, not an AI-assisted diagnostic or decision support tool. Therefore, an MRMC study and
the concept of "human readers improving with AI assistance" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not a standalone algorithm.
7. The type of ground truth used
For this device, the "ground truth" would relate to its structural integrity, biocompatibility, and ability to achieve its intended mechanical functions (e.g., restoring vertebral height, providing stability). This would be established through:
- Engineering testing: Mechanical (e.g., strength, fatigue) and chemical (e.g., material composition, biocompatibility) tests according to ASTM standards.
- Predicate device comparison: The EBI CAS Spine Spacer System (K042268) serves as the safety and efficacy benchmark.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that would have a training set.
9. How the ground truth for the training set was established
Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical implant and does not contain the type of information related to AI/ML device performance, such as test sets, ground truth establishment for AI, or human-in-the-loop studies. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, backed by presented mechanical and chemical information.
§ 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.