(43 days)
The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac ioint disruptions and degenerative sacroiliitis.
The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws.
This document describes the regulatory submission for the SImmetry Sacroiliac Joint Fusion System, a medical device, and therefore does not contain information related to software or AI system performance, ground truth, or study designs typically associated with such. The document focuses on showing substantial equivalence to a predicate device through non-clinical bench testing.
Here's an analysis of the provided text based on the requested information regarding acceptance criteria and a study proving those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bending Fatigue | "Results demonstrate that the implants perform as well or better than the predicate devices." |
| Torsion | "Results demonstrate that the implants perform as well or better than the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data, as this is a 510(k) submission for a modification to a previously cleared device, focusing on non-clinical bench testing.
- Sample Size: Not explicitly stated for bench tests (e.g., number of screws tested). It refers to "the worst case SImmetry implant" which suggests a limited number of samples were used for testing the specific modification.
- Data Provenance: The data is from "Non-Clinical bench tests" performed by Zyga Technology, Inc. There is no information regarding country of origin or whether it's retrospective or prospective, as these terms are not applicable to bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" here is established by standardized mechanical testing protocols (ASTM F1264 for bending fatigue and ASTM F543 for torsion). No human experts or clinical ground truth are involved in evaluating the performance of the device against these mechanical standards.
4. Adjudication Method for the Test Set
This is not applicable. The "test set" refers to mechanical bench testing, where outcomes are quantitative measurements based on engineering standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC) is relevant for evaluating human performance, often in conjunction with AI, typically in diagnostic imaging. The submission is for a medical implant and relies on non-clinical bench testing, not clinical studies involving human readers. Therefore, no effect size for human readers improving with or without AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document describes a physical medical implant, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by standardized mechanical test methods (ASTM F1264 for bending fatigue and ASTM F543 for torsion) and comparison against a legally marketed predicate device. The goal is to demonstrate that the modified device performs "as well or better" than the predicate under these objective engineering tests.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set."
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study described is a series of non-clinical bench tests.
- Study Design: Mechanical testing was performed on "the worst case SImmetry implant" using established ASTM standards.
- Tests Conducted:
- Bending fatigue per ASTM F1264
- Torsion per ASTM F543
- Objective: To demonstrate that the modified SImmetry Sacroiliac Joint Fusion System performs as well as or better than its predicate device (K111801).
- Conclusion: The tests demonstrated that the implants perform "as well or better than the predicate devices," leading to the conclusion of substantial equivalence based on mechanical performance.
This type of submission focuses on demonstrating the safety and effectiveness of a device modification through engineering principles and comparative mechanical performance, rather than clinical efficacy, for which a different type of study would be required.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.