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The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.c. T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture).

The CPOD/LPOD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. middle alle posterior upmar over and to be packed into the interior openings of the device prior to implantation.

The CPOD/LPOD is intended to be used with supplemental, internal spinal fixation The Cr OD/El OD is intended to or arm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).

The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The Theken CPOD / LPOD VBR System is designed to be constructed using two cage components in conjunction with an appropriate single spacer component. This combination of components creates an implantable construct. The use of a single cage as an implant has not been tested or approved.

The provided text describes a 510(k) premarket notification for a medical device called the "Theken Surgical CPOD / LPOD Vertebral Body Replacement System (CPOD / LPOD VBR)". This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the typical sense of algorithm-based device evaluations.

Therefore, many of the requested categories for a study proving acceptance criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context, as this is a regulatory submission for a physical medical implant, not an AI/algorithm-based diagnostic or screening tool.

However, I can extract information related to the device's characteristics and the basis for its approval.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance metrics like one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is therefore implicitly "equivalent" to that of the predicate devices.

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

• Not Applicable. This is a 510(k) for a physical implant, not a study involving a "test set" of patient data for performance evaluation in the typical sense. Equivalence is established through comparison of design, materials, intended use, and mechanical testing on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable. See point 2. The "ground truth" here relates to engineering principles, material science, and clinical practice for spinal implants. Regulatory bodies (FDA) and potentially design engineers at Theken Surgical/consultants would be the "experts" in this context, evaluating compliance with standards and equivalence.

4. Adjudication Method:

• Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not a diagnostic device or an AI assistant for human readers. Therefore, an MRMC study is not relevant.

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:

• The "ground truth" for the device's acceptability is based on:
  • Regulatory Standards: Compliance with FDA regulations (e.g., 21 CFR 878.3060 for Vertebral Body Replacement Devices).
  • Material Standards: Use of ASTM F-136 compliant Titanium Ti-6Al-4V (ELI).
  • Biomechanical Engineering Principles: The design's ability to restore biomechanical integrity.
  • Clinical Precedent: The established safety and effectiveness of the predicate devices.
  • Mechanical Testing: Though not detailed in the provided text, the document mentions "mechanical testing" as a basis for equivalence. This typically involves in-vitro biomechanical tests simulating physiological loads on the implant.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning model.

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

• Not Applicable. This is not an AI/machine learning model.

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