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The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable verteral body resected or excised during partial and total vertebrectory procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

It is recommended to pack bone graft material inside the implant.

The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The Supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

The AVSTM PL Peek Spacer is a rectangular shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The spacer incorporates two (2) Tantalum marker pins to aid in radiographic visualization. The AVSTM PL Peek Spacer System is comprised of six (6) different sized footprints with a variety of heights and lordotic angles.

The provided document is a Special 510(k) Premarket Notification for a line extension to the AVS™ PL PEEK Spacer System. This type of submission is typically for modifications to an already cleared device and relies on substantial equivalence to a predicate device, rather than requiring extensive new clinical studies to prove performance against specific acceptance criteria for a novel AI/software component.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with the evaluation of AI/ML or diagnostic devices.

Here's why the requested information is absent and what the document does provide:

1. Acceptance Criteria and Reported Device Performance:

• This document focuses on demonstrating substantial equivalence to a predicate device (Stryker Spine AVSTM PL PEEK Spacer, K050624) for additional sizes of an existing spinal implant.
• The "performance" criteria for such a device are primarily related to its mechanical properties, biocompatibility, and intended use matching the predicate device. These are assessed through non-clinical testing (e.g., mechanical tests, material characterization) and comparison to the predicate, not typically reported in a table of "device performance" in the same way an AI/ML device would report accuracy, sensitivity, or specificity.
• The document states: "Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ PL PEEK Spacer to be substantially equivalent to their predicate device in terms of its material, design, and indications for use." This is the core "acceptance" criteria for a 510(k) line extension.

2. Sample Size Used for the Test Set and Data Provenance:

• No "test set" in the context of an AI/ML device (e.g., patient images, patient records) is mentioned because this is a physical medical device. The "testing" would involve benchtop mechanical testing, not a dataset of patient cases.
• Therefore, there is no data provenance (country of origin, retrospective/prospective) for a "test set."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This concept is not applicable here as there is no "ground truth" to establish for an AI/ML model's output. The "truth" for a spinal implant relates to its material properties, dimensions, and mechanical performance, which are evaluated through engineering principles and standardized tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method:

• Not applicable for the same reasons as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. MRMC studies are used to evaluate the impact of AI/ML systems on human reader performance, which is not relevant for a physical spinal implant.

6. Standalone (Algorithm Only) Performance:

• Not applicable as there is no algorithm or software being evaluated.

7. Type of Ground Truth Used:

• Not applicable. The "ground truth" for ensuring the safety and effectiveness of this PEEK spacer would involve engineering specifications, material standards, and biomechanical testing results, not medical expert consensus, pathology, or outcomes data in the context of an AI system.

8. Sample Size for the Training Set:

• Not applicable as there is no AI/ML model to train.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as there is no AI/ML model or training set.

In summary, the provided document is a regulatory submission for a physical medical device (vertebral body replacement) focusing on a line extension (new sizes). It relies on the concept of substantial equivalence to a predicate device, which is proven through non-clinical performance data and comparison, rather than clinical studies or data science metrics typically associated with AI/ML device evaluations.

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