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510(k) Data Aggregation
(217 days)
EVOL**®** -SI Joint Fusion System
The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.
Here's an analysis of the provided FDA 510(k) summary, specifically focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test) | Criterion (Pass/Fail) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Substantial equivalent performance to predicate devices | "The mechanical testing results demonstrate that the EVOL® -SI Joint Fusion System is substantially equivalent to the predicate device." |
| Static 3-point bending | Per ASTM F543 | Passed |
| Axial Pullout | Per ASTM F543 | Passed |
| Torque to Failure | Per ASTM F543 | Passed |
| Dynamic Three-Point | Per ASTM F1264 | Passed |
| Non-Pyrogenicity Endotoxin Testing | ) | "The subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical and endotoxin tests. It refers to "the worst-case subject EVOL® -SI Joint Fusion System implants" for endotoxin testing, implying a limited number. The data provenance is not specified, but these are typically laboratory-based tests performed by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's performance is objectively measured against engineering standards (ASTM) and biological contamination limits (ANSI/AAMI, USP), not against expert interpretations of data.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no human interpretation or adjudication involved in the mechanical or endotoxin testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a medical device (surgical implant) and not an AI/imaging diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established through:
- Established engineering standards: ASTM F543 and ASTM F1264 for mechanical properties.
- Established biological safety standards: ANSI/AAMI ST72 and USP for endotoxin limits.
- Comparison to predicate devices: The "substantial equivalence" is based on the new device's performance meeting or exceeding that of legally marketed predicate devices, which serve as a benchmark for safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (see point 8).
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