(101 days)
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Simpact Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine Simpact Sacroiliac Joint Fixation System components should never be reused under any circumstances.
Here's a breakdown of the acceptance criteria and study information for the Life Spine SIMPACT Sacroiliac Joint Fixation System, based on the provided FDA 510(k) summary:
This device is not an AI/ML powered device, therefore no AI-specific information is available. The submission is for a traditional medical device (sacroiliac joint fixation system) and focuses on demonstrating substantial equivalence to existing predicate devices through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.
However, I can extract the information relevant to a traditional medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Static Screw Pull-Out (ASTM F543 A1.A2 & A3) | Presented to demonstrate substantial equivalency to predicate device. (Specific numerical results are not provided in this summary, but the implication is that it met the required thresholds for equivalence.) |
| Screw Driving Torque (ASTM F543 A1.A2 & A3) | Presented to demonstrate substantial equivalency to predicate device. (Specific numerical results are not provided in this summary, but the implication is that it met the required thresholds for equivalence.) |
| Indications for Use | Substantially equivalent to predicate devices. |
| Design | Substantially equivalent to predicate devices. |
| Materials Used | Substantially equivalent to predicate devices (Titanium alloy 6AL-4V-ELI per ASTM F-136). |
| Mechanical Performance | Substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of screws tested) for the ASTM F543 tests. These are typically benchtop mechanical tests performed on a sufficient number of samples to ensure statistical validity and representativeness. The data provenance is laboratory testing rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is not AI-powered, and ground truth in the context of clinical expert consensus is not relevant for this type of mechanical testing. The "ground truth" here is adherence to mechanical standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical consensus in diagnostic studies, not for mechanical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or AI-related comparative effectiveness was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through adherence to recognized international standards for medical device materials and mechanical testing (ASTM F543). The performance is compared to that of legally marketed predicate devices, implying that the predicate devices' performance against these standards sets the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve a training set.
§ 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.