(254 days)
The Genesys Spine Anterior Buttress Plate system in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The Genesys Spine Anterior Buttress Plate System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine buttress plate and screws that are inserted into the anterior surface of adjacent lumbar vertebrae.
This document describes the Genesys Spine Anterior Buttress Plate System, a medical device, and its acceptance criteria for FDA clearance. The information provided heavily focuses on the mechanical performance testing of the device for substantial equivalence with predicate devices, rather than an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies are not applicable or cannot be extracted from this document.
Here's the breakdown of the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical test results for the Genesys Spine Anterior Buttress Plate System to be equivalent to (or greater than) previously cleared anterior buttress plate systems. | Static and dynamic cantilever bending testing (per ASTM F1717) on the worst-case construct demonstrated equivalence (or greater than) predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size. The document mentions "all possible configurations of the Anterior Buttress Plate System construct were analyzed in order to determine the worst case to be used for testing." It then states that "Static and dynamic cantilever bending testing... were then performed on the worst case Anterior Buttress Plate System construct." This implies that one "worst-case" construct (or a representative number of units of that construct) was tested. Specific numbers of units tested are not provided.
- Data Provenance: The data is based on mechanical testing of the device, not clinical or image-based data from human subjects. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense for patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This question is Not Applicable (N/A). The ground truth for this device's performance is established through objective mechanical engineering standards (ASTM F1717) and comparison to predicate devices, not through expert human interpretation of data.
4. Adjudication Method for the Test Set
- This question is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on clinical data (e.g., image interpretation). This study relies on objective mechanical testing results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This question is Not Applicable (N/A). This is a study of a physical medical implant (spinal plate), not an AI-based diagnostic or assistive device that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This question is Not Applicable (N/A). This device is a physical implant, not an algorithm. Its performance is evaluated through mechanical testing, which is inherently "standalone" in the sense that it doesn't involve human interaction during the test itself, but it's not an algorithm.
7. Type of Ground Truth Used
- The ground truth used is based on objective mechanical performance standards (ASTM F1717) and the established mechanical properties of legally marketed predicate devices. The goal was to prove "equivalence to (or greater than)" these predicate devices.
8. Sample Size for the Training Set
- This question is Not Applicable (N/A). This is not an AI/ML device that requires a training set. The device's design is based on engineering principles and existing predicate devices.
9. How the Ground Truth for the Training Set Was Established
- This question is Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question does not apply.
§ 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.