Search Results

The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

The Velofix™ TLIF Cage consists of implants available in various heights, width, length and angle with an open architecture to accept packing of auto bone graft material. The Velofix™ TLIF Cage may be implanted a single device via a transforaminal approach and adopted to the anterior anatomy of the vertebral endplates.

The Velofix™ TLIF Cage device has two types: the one is consisted of cage body (PEEK), articulating component (Ti Alloy) and radiographic markers (Tantalum); the other is consisted of cage body and articulating component made of Ti Alloy. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning.

The Velofix™ TLIF Cage implant is manufactured from either

1. Polyetheretherketone (PEEK) with a titanium alloy for articulating component (Ti6Al4V ELI), and tantalum radiographic markers for spinal applications, or

2. Titanium alloy (Ti6Al4V ELI) for cage body and articulating component for spinal applications.

The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) premarket notification for a medical device called the Velofix™ TLIF Cage, specifically an update to introduce a titanium alloy version. The document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested information points (such as acceptance criteria, reported device performance, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document is a summary demonstrating equivalency, not a detailed study report.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific quantitative acceptance criteria for performance in a clinical setting. It states that mechanical strength evaluation was conducted for comparison, but no specific criteria or reported performance values are given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document explicitly states: "Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage." It refers to a "mechanical strength evaluation" but does not detail a test set, sample size, or data provenance. This is a regulatory filing for a device, not a human clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. "Ground truth" in the context of device performance, especially for a spinal implant, would typically come from clinical outcomes, pathology, or expert assessment in a clinical trial. This document does not describe such a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Since no clinical or bench test set with expert assessment is detailed, no adjudication method is mentioned.

5. 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

This information is not provided. An MRMC study is relevant for AI or imaging interpretation devices. The Velofix™ TLIF Cage is an intervertebral body fusion device (an implant), not an AI or imaging device, so an MRMC study would not be applicable to its intended use.

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

This information is not provided. This question is relevant for AI algorithms. The Velofix™ TLIF Cage is a physical implant, so the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided. As a physical implant aiming for substantial equivalence, the "ground truth" for its performance would typically relate to fusion rates, complication rates, and pain reduction, assessed through clinical outcomes. However, this submission does not detail such studies or outcomes data as it relies on equivalency to existing devices.

8. The sample size for the training set

This information is not provided. This question is relevant for machine learning models. The Velofix™ TLIF Cage is a physical medical device, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not provided. This question is relevant for machine learning models. As it's a physical device, this concept does not apply.

Summary of what the document does state about "studies" and "performance":

The document states:

• "Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage." (This refers to the proposed device, which is the titanium alloy version).
• "However, the mechanical strength evaluation was conducted to compare data of proposed device of the Velofix™ TLIF Cage (K172419) and to verify there are no new safety and effectiveness issues were not raised by the proposed device." (K172419 is the primary predicate device, which was made of PEEK. This suggests a comparison of the new titanium version to the previously cleared PEEK version, not a de novo study against explicit criteria.)
• The conclusion is that the device is "substantially equivalent to predicate devices with respect to indications for use and technological characteristics," implying that the performance is considered similar, therefore acceptable.

Ask a specific question about this device

The Altus Spine Cervical Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from C3-C7. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade I spondylolisthesis at the involved level(s).

The Altus Spine Cervical Interbody Fusion is to be combined with cleared supplemental fixation systems, such as the Altus Cervical Plate System.

The Altus Spine Cervical Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Cervical Interbody Fusion System implants are made of PEEK with Tantalum conforming to ASTM F2026 and ASTM F560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Cervical Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

This document is a 510(k) Summary for the Altus Spine Cervical Interbody Fusion System (K172253). It describes the device, its indications for use, and a summary of non-clinical tests conducted to establish substantial equivalence to predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, it relies on comparative testing to a predicate device. The general acceptance criterion is "substantially equivalent" to the predicate device.

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

• Sample Size: The document does not specify the sample size for each of the 8 different non-clinical tests performed. It only states that "8 different tests were conducted."
• Data Provenance: The tests are "non-clinical tests," meaning they were conducted in a lab setting (e.g., mechanical testing) rather than on human or animal subjects. The country of origin is not specified, but the submission is to the U.S. FDA. The data is prospective for the device under review, as these are tests performed on the actual device to support the 510(k).

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

This is not applicable to this type of submission. The "ground truth" here is established by standardized testing protocols (ASTM standards) and engineering principles, not by expert medical consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human readers or interpretation of medical images. The evaluation is based on objective measurements from mechanical tests.

5. 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 interbody fusion system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant to this submission.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical tests is defined by the requirements and test methods specified in the ASTM standards (F2077-14 and F2267-04), which are recognized industry standards for spinal implant testing. The performance of the test device is compared against the performance of the predicate device under these standardized conditions.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

Ask a specific question about this device