WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM

• K Number: K100820
• Device Name: WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM
• Manufacturer: WENZEL SPINE
• Date Cleared: 2010-08-05 ( 135 days)
• Product Code: MAX
• Regulation Number: 888.3080
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

The Wenzel SpineVariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

Device Description

The proposed Wenzel Spine VariLift Interbody Fusion System will be offered in two (2) configurations of various sizes that are designed based on indicated spinal implant level and surgical approach, and consist of:

• 1. VariLift-L, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
• 2. VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach.
     The VariLift-L and VariLift-A are grooved and fluted devices with large fenestrations (araft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The VariLift-L and VariLift-A are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.

AI/ML Overview

This document describes the Wenzel Spine VariLift Interbody Fusion System, a medical device for lumbar spine fusion. It does not contain information about an AI/ML device or its performance characteristics. Therefore, I cannot extract the requested details regarding acceptance criteria, study design, ground truth, or expert involvement as these are not relevant to the provided text.

The document primarily focuses on:

• Device Description: The physical characteristics and components of the VariLift-L and VariLift-A systems.
• Indications for Use: The medical conditions and surgical approaches for which the device is intended.
• Technological Characteristics: How the device is similar to previously cleared predicate devices.
• Non-Clinical Testing: A list of conducted mechanical tests (static and dynamic compression, shear, torsion, subsidence, expulsion) conforming to ASTM standards.
• Clinical Testing: A statement that clinical data was submitted, demonstrating substantial equivalence to predicates, and noting that the clinical trial was conducted without supplemental fixation.
• FDA Clearance: Confirmation of 510(k) clearance for the device.

To address your request, specifically point 1 (A table of acceptance criteria and the reported device performance), point 2-7 (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type), point 8-9 (training set, ground truth for training), I would need a different type of document that details the development and evaluation of an AI/ML system.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.