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The ARROWHEAD™ Spinal System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The ARROWHEAD™ Spinal System consists of a variety of shapes and sizes of screws and 4.5mm rods. The implant components can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. The implants are made of titanium alloy and commercially pure titanium. Stainless steel and titanium implant components must not be used together in a construct. The ARROWHEAD™ Spinal System components can be used with CD HORIZON® ECLIPSE® 4.5mm Rods and TSRH® 3D Short Post Screws.

This 510(k) summary for the Medtronic Sofamor Danek ARROWHEAD™ Spinal System (K032560) explicitly states that mechanical testing was performed on the device, and "The test results were provided in this submission." However, the provided document does not contain the acceptance criteria or the specific results of these mechanical tests.

Therefore, I cannot fulfill all parts of your request with the given information. Based on the provided text, here's what can be extracted and what cannot:

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

• Cannot be provided. The document states mechanical testing was done but does not detail the acceptance criteria or the specific performance results in a table format.

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

• Cannot be provided. The document does not specify the sample size for the mechanical tests, the country of origin of the data, or whether it was retrospective or prospective.

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. This device is a mechanical spinal system, not an AI/software device that relies on expert interpretation of medical images or data for its primary function. The "ground truth" here would relate to engineering standards and mechanical integrity, not diagnostic accuracy requiring medical experts.

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

• Not applicable. See point 3. Adjudication methods are relevant for studies resolving disagreements among human reviewers, typically in AI/software performance validation.

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 is a physical medical device, not an AI-assisted diagnostic tool. An MRMC study would not be relevant here.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Likely engineering standards/specifications. While not explicitly stated, for a mechanical spinal system, the "ground truth" for performance would be based on established engineering standards for strength, fatigue, pull-out resistance, etc., as well as comparison to predicate devices, rather than medical "ground truth" like pathology or expert consensus on clinical findings.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. See point 8.

In summary, the provided 510(k) summary (K032560) indicates that mechanical testing was performed to demonstrate the safety and effectiveness of the ARROWHEAD™ Spinal System. However, it does not provide the specific details regarding the acceptance criteria, the results of the performance testing, or the methodology of the testing in a way that aligns with the questions relevant to AI/software device evaluation. The document focuses on demonstrating substantial equivalence to predicate devices through device description, intended use, and general mention of mechanical testing without elaborating on its specifics.

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