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The SImmetry+ System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SImmetry+ System consists of sterile packaged fully threaded titanium Implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 9.5mm-14.5mm, in 1mm increments. Implant lengths in 5mm increments range from 30mm to 110mm. All devices are additively manufactured from Titanium Alloy (Ti-6Al4V ELI).

This 510(k) clearance letter pertains to the SImmetry+ System, a device for sacroiliac joint fusion (a metallic bone fixation fastener). Unlike a clearance for a software device or AI/ML system, this document focuses on the physical and mechanical performance of the implantable device.

Therefore, the requested information regarding acceptance criteria and study that proves the device meets the acceptance criteria specifically in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, expert consensus on images, etc.) is not applicable to this type of medical device clearance.

The provided document describes:

• Device Type: A physical, implantable device (fully threaded titanium implants for sacroiliac joint fusion).
• Acceptance Criteria (Implicitly): Demonstrated through non-clinical performance testing against specific ASTM standards. These standards define the expected mechanical properties (e.g., static and dynamic cantilever testing, axial pullout, torsional properties, driving torque).
• Study Proving Acceptance: "Non-clinical testing data" was submitted, including:
  • Static and dynamic cantilever testing per ASTM F2193
  • Axial pullout testing per ASTM F543
  • Torsional properties testing per ASTM F543
  • Driving torque testing per ASTM F543
  • Additive manufacturing characterization

Summary of Requested Information based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Mechanical performance standards defined by ASTM F2193 and ASTM F543, and additive manufacturing characterization. (Specific numerical thresholds are not provided in this public clearance letter, but would have been part of the confidential submission.)
   • Reported Device Performance: The document states that SiVantage completed non-clinical testing and the data demonstrates substantial equivalence. This implies the device met the performance criteria outlined in the standards.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical implants subjected to mechanical testing, not a dataset of patient information for AI/ML evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is established by engineering measurements against defined material and mechanical standards.

4. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human interpretation of medical images, often with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML algorithm performance.

7. The type of ground truth used:

   • For the physical device: Engineering specifications, material properties, and mechanical performance standards (ASTM F2193, ASTM F543).

8. The sample size for the training set: Not applicable. The "training set" concept applies to AI/ML model development. For a physical device, manufacturing processes are refined, but there isn't a "training set" in the AI sense.

9. How the ground truth for the training set was established: Not applicable for a physical device.

In conclusion, this FDA 510(k) clearance is for a conventional mechanical implant, not an AI/ML powered device. Therefore, many of the questions asked, which are highly relevant for AI/ML device clearances, do not apply to the details provided in this document. The "proof" of meeting acceptance criteria for this device rests on its physical and mechanical characteristics meeting established engineering standards and showing substantial equivalence to existing predicate devices based on those characteristics.

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