(78 days)
SICAGE is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrollitis.
SICAGE is a fully threaded bone screw offered in a single diameter and various lengths to accommodate variability in patient anatomy. SICAGE is sold sterile. The SICAGE System includes implants and instruments for implantation.
This document is a 510(k) premarket notification for the SICAGE™ System, a fully threaded bone screw intended for sacroiliac joint fusion. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study on acceptance criteria for an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and testing is not applicable.
Here's an attempt to answer the questions based on the provided text, recognizing its limitations for AI/ML criteria:
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical medical device (a bone screw), the "acceptance criteria" and "reported device performance" are based on mechanical testing standards, not AI/ML metrics like sensitivity, specificity, or accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Meets Torsion Strength per ASTM F543 | SICAGE System demonstrated performance substantially equivalent to predicate devices for torsion. |
| Meets Pullout Strength per ASTM F543 | SICAGE System demonstrated performance substantially equivalent to predicate devices for pullout. |
| Meets Static Bending Strength per ASTM F2193 | SICAGE System demonstrated performance substantially equivalent to predicate devices for static bending. |
| Meets Dynamic Bending Strength per ASTM F2193 | SICAGE System demonstrated performance substantially equivalent to predicate devices for dynamic bending. |
| Material Properties per ASTM F136 (Ti-6Al-4V ELI titanium alloy) | SICAGE bone screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136), meeting material requirements. |
| Design/Dimensions similar to predicate devices | Sizes (dimensions are comparable to those offered by the predicate systems) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as this is mechanical testing of a device, not a data-driven clinical study with human subjects. The "test set" would refer to the number of screws and test repetitions.
- Data Provenance: Not applicable in the context of mechanical device testing. The results are from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. Ground truth for mechanical testing is established by adherence to recognized ASTM standards and measurement results, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Mechanical testing involves standardized procedures and objective measurements, not subjective adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a bone screw, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone screw.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F543, ASTM F2193). The performance is assessed against these established engineering and material requirements.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.