(125 days)
The Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and Ventrofix. The interior of the spacer can be packed with bone (autograft or allograft). The Oracle 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.
The Synthes Oracle Spacer is a radiolucent vertebral body replacement device used in conjunction with supplemental fixation that provides structural stability in skeletally mature individuals following partial or total corpectomy. The Oracle Spacer has an oval shape and may be used to accommodate the anatomical requirements of the space created by the corpectomy. The spacer has an open architecture for packing bone graft material and it is available in various heights, cross-sectional sizes and lordosis angles to suit individual pathology and anatomical conditions.
The provided document is a 510(k) summary for the Synthes Oracle Spacer. It details the device's description, intended use, and claims of substantial equivalence. However, it does not contain information about specific acceptance criteria or an analytical study with defined performance metrics, a test set, ground truth, or expert involvement as typically required for AI/algorithm-based devices.
The "Performance Data" section states: "Mechanical test data is presented in conformance with the “Guidance for Spinal System 510(k)s”, issued May 3, 2004." This indicates that the device's performance was evaluated through physical/mechanical testing, common for implantable medical devices, rather than through an analysis of an algorithm's output on digital data.
Therefore, many of the requested fields cannot be filled as they pertain to studies evaluating the performance of an algorithm or AI system, which is not what this document describes.
Here's a breakdown of the available information and why other fields cannot be completed:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with "Guidance for Spinal System 510(k)s" | "Mechanical test data is presented in conformance with the “Guidance for Spinal System 510(k)s”, issued May 3, 2004." (Exact quantitative results are not provided in this summary.) |
| Substantial equivalence to predicate devices (K011037, K010530) | "Documentation has been provided that demonstrates that the Synthes Oracle Spacer is substantially equivalent to the previously cleared Synthes Vertebral Spacer (K011037) and the Interpore Cross Geo™ Structure (K010530)." |
| Material conformance to ASTM Standards | "Radiolucent polymer and titanium alloy materials in conformance with ASTM Standards." |
| Restoration of biomechanical integrity of the spinal column | "The Oracle 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." (This is an intended design feature, not a quantitative performance metric from a study in this summary.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes mechanical testing of a physical implant, not an algorithm evaluated on a data test set.
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. Ground truth for an AI algorithm is not relevant for the mechanical testing of a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an algorithm evaluation study.
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 physical 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 is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For mechanical testing, the "ground truth" would be the physical properties and performance measured against engineering specifications and industry standards rather than a medical diagnosis.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth.
In summary: The provided 510(k) summary is for a physical medical device (vertebral body replacement) and details its substantial equivalence to predicate devices and conformance to mechanical testing guidance. It does not involve any AI or algorithmic component, and therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/algorithms cannot be extracted.
§ 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.