(191 days)
The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior posterior inferior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from 135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
This FDA 510(k) submission for the SIGNUS SACRONAIL® Transsacral Stabilization System does not contain information about acceptance criteria or a study proving the device meets those criteria in a traditional sense of clinical performance or diagnostic accuracy.
Instead, this submission is for a medical device (an implantable hardware system) where the primary focus for substantial equivalence is on mechanical performance, biocompatibility, and intended use comparison to predicate devices.
Therefore, I cannot populate most of the requested fields as they pertain to studies typically performed for diagnostic devices or AI algorithms.
Here's a breakdown of what can be extracted from the provided text, and where gaps exist based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (spinal implant), "acceptance criteria" are generally related to demonstrating mechanical equivalence to predicate devices and biocompatibility, rather than a clinical performance metric like sensitivity or specificity.
| Acceptance Criteria Category | Specific Criteria (Implied from testing) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Equivalence to predicate devices in mechanical properties relevant for its intended use (fixation of pelvic/sacral fractures). | "The detailed mechanical testing shows that in summary, the SACRONAIL® Transsacral System provides equivalent mechanical properties compared to the predicate for this intended use." (Section 10.2) |
| Biocompatibility | Meet ISO 10993 standards for implant devices with tissue/bone contact and permanent contact, using Ti6Al4V (ASTM F 136 / ISO 5832-3) with Type II anodization. | "The presented results in this submission show that pedicle screw systems made from Titanium Alloy per ASTM F136 have a high demonstrable biological safety. No concerns arose that would preclude clinical use of SACRONAIL® Transsacral Stabilization System. The requirements of the ISO 10993 standard series are fulfilled." (Section 10.1) |
| Material Composition | Use of recognized, safe medical-grade materials. | Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. (Section 8) |
| Intended Use | Match the intended use of predicate devices for fixation of posterior pelvic and sacral fractures. | "The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior posterior inferior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint." (Section 7, page 4) This matches the implied intended use of predicate "Sacral Bar" and "Cannulated Screws". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical performance or AI algorithm testing. Mechanical testing would involve specific numbers of test articles, but these are not analogous to a "test set" of patient data.
- Data Provenance: Not applicable for clinical/AI test sets. For mechanical testing, the articles are new devices and the comparative data would come from published standards or predicate device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device's evaluation relies on mechanical and biocompatibility testing, not clinical "ground truth" derived from expert review of patient data.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a hardware device, not a diagnostic or AI-assisted system for interpretation.
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
- For mechanical testing: Engineering standards (e.g., ASTM F1264-16, ASTM F1717-15, ASTM F543) serve as the "ground truth" or benchmark for performance.
- For biocompatibility: ISO 10993 standards and established literature on medical-grade titanium alloy.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.