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The SImmetry™ Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

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 use with the 6.5mm diameter screws.

The provided document is a 510(k) summary for the SImmetry™ Sacroiliac Joint Fusion System. This type of document is for a medical device that achieves substantial equivalence to a predicate device, rather than a novel AI/software as a medical device (SaMD) that would typically involve acceptance criteria and a study proving device performance in the way your request describes.

Therefore, the document does not contain the information needed to fulfill most of your request, such as acceptance criteria, specific study details with sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set information.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K110512) through:

• Identical intended use/indications for use.
• Identical design features, operational principles, and material composition.
• Mechanical performance testing to show the device provides necessary rigidity.

Here's a breakdown of what can be extracted and why other parts of your request cannot be answered from this specific document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance, as this is a medical implant, not a diagnostic AI/SaMD.

• Reported Device Performance: The document states, "Mechanical testing for axial pull out strength, driving torque, static bend strength and bending fatigue provided in this and previous 510(k)s demonstrate that the SImmetry Sacroiliac Joint Fusion System provides the necessary rigidity to support the intended use."

  Performance Metric (Type of Test)	Reported Outcome
  Axial pull out strength	Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance).
  Driving torque	Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance).
  Static bend strength	Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance).
  Bending fatigue	Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. This document describes mechanical testing of physical implants, not an AI/SaMD test set. There's no mention of human data, clinical performance, or a "test set" in the context of diagnostic accuracy.

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 / Not Provided. There is no "ground truth" establishment by medical experts described, as this is a mechanical device, not an AI system being evaluated for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No adjudication method is necessary or mentioned for the mechanical testing described.

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 / Not Provided. This is not an AI/SaMD and therefore no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable / Not Provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. For the mechanical tests, the "ground truth" would be the engineering specifications and material properties, against which the device performance is measured. This is not a "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/SaMD and therefore has no training set.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. This is not an AI/SaMD and therefore has no training set or associated ground truth establishment.

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