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This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative 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 or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) implants which will be offered in twenty-four (24) size configurations to accommodate individual patient anatomy. The implants are designed to facilitate a specific surgical technique, the Oblique Lateral Lumbar approach (OLLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "Lumbar Interbody Fusion System (OLLIF)". It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, materials, technological characteristics, and labeling, supported by pre-clinical performance data.

Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device, which would typically involve human-in-the-loop or standalone performance metrics, ground truth establishment, expert adjudication, and sample sizes for training and testing.

The document details:

• Device Name: Lumbar Interbody Fusion System (OLLIF)
• Regulatory Class: Class II
• Product Code: MAX (Intervertebral Body Fusion Device, Lumbar)
• Indications for Use: Intervertebral body fusion of the lumbar spine (L2 to S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis, after six months of non-operative treatment, for one or two contiguous levels. It requires supplemental fixation and autograft.
• Predicate Devices: Python Interbody Fusion Device (K090064) and Buttress (Fang) Plate System (K090415)
• Performance Data: Static and dynamic axial compression testing following ASTM F2077-14, and subsidence testing following ASTM F2267-04. These are bench tests of the physical device's mechanical properties, not clinical performance or AI/ML algorithm performance.

In summary, this document is for a traditional medical device (spinal implant), not an AI/ML device. Therefore, the requested information about acceptance criteria for AI algorithm performance, study design (e.g., MRMC, standalone), ground truth derivation, and sample sizes for AI model training/testing is not present in this document.

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The Vail ALIF Buttress Plate System in conjunction with tradition is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

The Vail ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Titanium Alloy 6AL-4V ELI per ASTM F136. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Vail ALIF Buttress Plate System is provided non-sterile, for single use only.

This is a 510(k) premarket notification for a medical device (Vail ALIF Buttress Plate System), not a study evaluating software or AI performance. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies of AI/software devices, is not available in this document.

The document describes the device, its intended use, and compares it to predicate devices based on design and material. It also mentions "performance data" but these refer to mechanical tests of the physical implant, not clinical or algorithmic performance from a study.

Here's a breakdown of what is provided regarding "performance data" in this document:

• Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of an AI/software device. The document states:
  • Acceptance Criteria for the Vail ALIF Buttress Plate System: "met all specified criteria" for "Static Cantilever Bending" and "Dynamic Cantilever Bending." The specific numerical criteria are not detailed in this summary but would have been part of the full 510(k) submission.
  • Reported Device Performance: The device withstood static and dynamic cantilever bending without failure, demonstrating "a safety and effectiveness profile that is equivalent to the predicate device."
• Study That Proves the Device Meets the Acceptance Criteria: The study mentioned is a series of mechanical performance tests, specifically:
  • Static Cantilever Bending
  • Dynamic Cantilever Bending
  • No details about the sample size (number of devices tested), data provenance, or explicit ground truth are provided, as these are material and mechanical tests, not clinical efficacy studies or AI performance evaluations.

The remaining requested information (2-9) is not applicable or present in this 510(k) summary because it pertains to the evaluation of AI/software performance, which this device is not.

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