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VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.

The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft oone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The VLIFT®-s Vertebral Body Replacement System is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The device may be distracted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. As the implant is distracted via its inner concentric ring, additional slotted openings appear.

The VLIFT®-s cages are available in various diameters and heights.

Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at the rim of the end cap attachments help to anchor the implant to the end plates of the vertebral bodies. The VLIFT®-s end caps are available in both flush and contoured designs and are offered in a variety of angles.

Extension pieces are available for each diameter for the VLIFT®-s implants. Extension pieces may be used to achieve the desired height. The use of extension pieces is optional.

The provided text is a 510(k) summary for a medical device called the "VLIFT®-s Vertebral Body Replacement System." This document is not for an AI/ML device, but rather a physical implant. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable or available in this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for an expanded indication of use (cervical spine). It emphasizes that no changes were made to the actual implants and, consequently, no additional testing was required or performed due to the existing clinical literature demonstrating substantial equivalence.

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The INNESIS PEEK Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

Here's a breakdown of the acceptance criteria and study information for the INNESIS PEEK Cervical Cage, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and the mechanical performance of the INNESIS PEEK Cervical Cage. The acceptance criteria are based on established ASTM standards for intervertebral body fusion devices.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing results are for the following:" followed by the list of tests and standards. It then concludes by saying "These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process." While it directly states biocompatibility and endotoxin results, for the mechanical tests, it implicitly suggests that the device met the requirements of the standards by stating testing was conducted in accordance with them, which is the typical approach for demonstrating substantial equivalence for mechanical properties.

Study Details

The provided text describes pre-clinical, often benchtop, testing rather than a clinical study. Therefore, some of the requested information regarding clinical study design (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified for individual tests. For mechanical testing of medical devices, samples are typically physical units of the device tested under controlled laboratory conditions.
   • Data Provenance: Not explicitly stated, but implied to be from laboratory testing performed by BK Meditech Co, Ltd. or a contracted testing facility, likely in the Republic of Korea given the company's origin. The data is retrospective in the sense that it's generated for regulatory submission after device development.

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

   • This is not applicable as the testing described is mechanical, material, and chemical (endotoxin) in nature, not based on expert interpretation of clinical data or images. The "ground truth" here is the adherence to the specified ASTM standards and the validated properties of the materials.

3. Adjudication method for the test set:

   • Not applicable for the type of testing performed. Mechanical and material tests have objective pass/fail criteria based on quantitative measurements against a standard.

4. 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 device is an implantable medical device (cervical cage), not an AI diagnostic or image interpretation tool. Therefore, no MRMC study or AI assistance is relevant.

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

   • Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:

   • For mechanical, material, and chemical tests: The ground truth is the performance specification defined by recognized industry standards (ASTM) and accepted material properties for biomaterials. For endotoxin testing, the ground truth is the absence of endotoxins at or below detectable levels.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model for this type of device submission. The device design and materials are based on established engineering principles and prior art (predicate devices), not machine learning.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and manufacturing is based on established engineering and materials science principles, industry standards, and the performance history of similar predicate devices.

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