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Cervical

KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Thoracolumbar

KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.

These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The KONG®-TL VBR System and the KONG®-C VBR System are vertebral body replacement systems designed to improve the stability of the cervical and thoracolumbar spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/ PEEK. BlackArmor®) and incorporate a rough titanium coating (Ti-TT®). The devices are intended to be used with supplemental spinal fixation.

Each implant is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.

This document is a 510(k) summary for the KONG®-TL VBR System and KONG®-C VBR System, which are vertebral body replacement systems. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present "acceptance criteria" in a typical quantitative sense (e.g., target accuracy, sensitivity/specificity values). Instead, the performance testing aims to demonstrate substantial equivalence to legally marketed predicate devices by conforming to established ASTM standards for various mechanical properties. The "reported device performance" are the results from these tests, which were deemed sufficient to show equivalence.

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

The document describes non-clinical mechanical performance testing. This typically involves physical samples of the medical device or its components.

• Sample Size: Not explicitly stated in terms of a numerical count of tested devices. It refers to "worst-case construct" for expulsion testing, implying selection based on anticipated highest stress. For other tests, it's implied that a statistically relevant number of samples were tested to meet ASTM standard requirements, but the exact number is not provided in this summary.
• Data Provenance: The tests are non-clinical (benchtop, laboratory testing) performed by "the company" (icotec ag). Since it's mechanical testing of the device itself, there is no patient data or "country of origin of the data" in the sense of clinical study demographics.

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

This question is not applicable. The study is a non-clinical mechanical performance test, not a clinical study involving diagnosis or interpretation by experts. The "ground truth" here is compliance with engineering standards and mechanical integrity, not medical findings.

4. Adjudication Method for the Test Set:

This question is not applicable. There is no expert adjudication needed for non-clinical mechanical testing. The results are typically objectively measured and compared against standard specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical mechanical performance testing to demonstrate substantial equivalence to predicate devices, not on a clinical comparison involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this question is not applicable. The device (KONG®-TL VBR System and KONG®-C VBR System) is a physical medical implant, not an AI algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for this non-clinical performance evaluation is based on established engineering standards (ASTM F2077, ASTM F2267) and the mechanical properties and performance of legally marketed predicate devices. The testing aims to show that the subject device performs similarly or meets the safety and effectiveness requirements defined by these standards, thereby demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. Since the device is a physical implant and the study is non-clinical mechanical testing, there is no "training set" in the context of an algorithm or statistical model.

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

This question is not applicable as there is no "training set" for this type of device and study.

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