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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 has 3 types as follows:

• 1. TLIF Cage, which is made of Polyether-ether-ketone (PEEK);
• 2. TLIF Ti Cage, which is made of Titanium alloy (Ti6Al4V ELI);
• 3. TLIF Ti LW Cage, which is made of Titanium alloy (Ti6Al4V ELI) with the expanded graft window of the side part.

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

The provided text is a 510(k) summary for the Velofix™ TLIF Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be typical for an AI-powered diagnostic device.

Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and human expert involvement are not applicable to this type of submission.

However, I can extract the relevant information concerning performance testing.

Here's a breakdown of the information that is available in the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to performance testing and implies that mechanical performance should be equivalent to or satisfy standards.

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

The document does not specify a "test set" in the context of a clinical study or a dataset of patients/images. The testing described is mechanical (material and device performance).
Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable here.

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

This information is not applicable as the study described is mechanical testing of a medical implant, not a study involving interpretation of data by human experts.

4. Adjudication method for the test set

This information is not applicable as the study described is mechanical testing of a medical implant, not a study involving interpretation of data.

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 applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic tool assisted by human readers.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

For the mechanical performance testing, the "ground truth" would be the established material properties (e.g., ASTM F136 for titanium alloy) and mechanical testing standards (ASTM F2077). These standards define how the material and device should perform under specified loads.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for the mechanical testing of this medical implant.

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

This information is not applicable.

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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.

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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 nonoperative 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 device is consisted of cage body, articulating component and radiographic markers. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning. 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 is constructed of medical grade Polyetheretherketone (PEEK for ASTM F2026) with a titanium alloy for articulating component (Ti6Al4V ELI for ASTM F136), and tantalum radiographic markers for spinal applications(Tantalum for ASTM F560). 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 the Velofix™ TLIF Cage. This is a medical device for intervertebral body fusion. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing (bench testing).

Here's an analysis based on your request, highlighting what information is available and what is not:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All tests met all acceptance criteria" and "The acceptance criteria for performance testing were developed using the data of the primary predicate, Velofix™ Interbody Fusion System (K132926, K140864)." However, the specific numerical thresholds for these acceptance criteria are not provided in this document.

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

• Sample Size for Test Set: Not explicitly stated. The tests are "bench testing" which typically involves a set number of implants for mechanical evaluation. The document mentions "selection of the worst case implants" through finite element analysis, implying that a specific subset of the device's configurations was tested.
• Data Provenance: The tests were "non-clinical setting (bench testing)," meaning conducted in a laboratory, not involving human or animal subjects. The location where the testing was performed is not specified, but the manufacturer is based in Korea. This is not patient data, so country of origin of data or retrospective/prospective does not apply in the typical sense.

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

• Not applicable. This study is non-clinical bench testing evaluating mechanical performance, not a clinical study requiring expert assessment of patient-derived data to establish ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This relates to clinical data assessment, not mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document describes non-clinical bench testing of a physical implant (cage), not an AI/software device that would involve human readers or MRMC studies.

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

• Not applicable. This is not an AI/software device. The testing described is for the mechanical performance of a physical implant.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance tests are the established biomechanical standards (ASTM F2077, ASTM F2267) and the performance data of the predicate devices. The device is considered to meet the acceptance criteria if its mechanical properties fall within acceptable ranges defined by these standards and predicate device performance.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/software device that requires a "training set" in the context of machine learning. The term "training set" is not relevant here.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

Summary of the Study:

The study described is a series of non-clinical bench tests designed to assess the mechanical performance of the Velofix™ TLIF Cage (an intervertebral body fusion device). The tests were conducted according to established ASTM standards (F2077 for compression and shear, F2267 for subsidence). The acceptance criteria for these tests were derived from the performance data of the predicate devices, primarily the Velofix™ Interbody Fusion System (K132926, K140864). The document states that all tests met their respective acceptance criteria, supporting the conclusion of substantial equivalence to predicate devices in mechanical performance. Finite element analysis was also used to identify "worst-case implants" for testing, although the specific number of implants tested is not detailed.

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