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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for posterior, 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), spondvlolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Titanium and Vitallium rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

This 510(k) is intended to introduce an extension to the existing MANTIS® Spinal System. The proposed line extension includes the addition of titanium Reduction Screws, and use of Stryker Spine Radius titanium and Vitallium® rods with other components of the MANTIS® and MANTIS® Redux Spinal Systems.

This is a 510(k) premarket notification for a medical device (MANTIS® Spinal System and MANTIS® Redux Spinal System) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a new drug or a novel AI diagnostic might.

Therefore, many of the requested fields cannot be directly extracted from this document as they are not relevant to a 510(k) for a spinal fixation system line extension. The information provided is primarily about mechanical testing and conformity to existing standards, showing the new components perform similarly to the predicate devices.

Here's an attempt to answer the questions based on the provided text, with explanations where information is not applicable or available:

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

The document states that "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This implies that the acceptance criteria are generally established by this FDA guidance and relevant consensus standards (e.g., relating to mechanical strength, fatigue, etc. for spinal fixation devices). However, specific quantitative acceptance criteria and reported performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance

The document mentions "Engineering analysis and testing." For mechanical devices, this typically involves testing a sample number of components and assemblies. The specific sample size for the mechanical testing is not provided in this summary.

• Test Set Sample Size: Not specified.
• Data Provenance: The testing would have been conducted by the manufacturer (Stryker Spine) or a contracted lab, likely in the US (Allendale, NJ is mentioned). It is a prospective generation of data for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to a 510(k) for a spinal fixation system line extension. "Ground truth" in the context of clinical expert review is relevant for diagnostic devices or AI algorithms evaluating patient data. For a mechanical device, performance is established through physical and engineering tests, not expert consensus on clinical cases.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, typically in clinical studies or AI algorithm validation. Mechanical tests have objective outputs.

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 mechanical device, not an AI diagnostic or assistance system. MRMC studies are for evaluating the performance of human readers, sometimes aided by AI, on clinical cases.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For mechanical testing, the "ground truth" is typically the physical properties and performance characteristics of the materials and device components, measured against established engineering standards (e.g., tensile strength, fatigue limits, compression strength, etc.).

8. The sample size for the training set

Not applicable. This concept applies to AI/ML models. For mechanical testing, there is no "training set" in this sense.

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

Not applicable.

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