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The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

VerteFIT Corpectomy Cages are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include central PEEK cores and titanium-coated PEEK endcaps which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endcaps can be intraoperatively assembled to best fit patient anatomy requirements. Each endcap has a central axial chamber to allow autogenous bone graft or allograft to be packed inside of the spacer. Unidirectional teeth on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. VerteFIT endcaps (superior and inferior) have slots to accommodate VerteBRIDGE anchoring plates.

This document describes the VerteFIT™ Corpectomy Cage System, a vertebral body replacement device. The provided text outlines the device's indications for use and non-clinical performance data, but it does not describe an acceptance criteria table, a study proving device adherence to acceptance criteria, nor does it contain information typically associated with studies of AI/ML devices (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The information provided pertains to the non-clinical performance data which focuses on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI/ML-specific study details.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated in a table format. The document implies compliance with standards and guidance documents, such as "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" and various ASTM standards (F2077, F2267, F2129).
• Reported Device Performance: The document states that "Mechanical testing was conducted... to demonstrate substantial equivalence to the predicate system(s)." Specific numerical performance results or whether these results "met" an explicit acceptance criterion are not detailed in this summary.

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

• Sample Size: Not applicable. The document refers to mechanical testing, not clinical studies involving patient data.
• Data Provenance: Not applicable. No patient data or clinical data is mentioned.

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)

• Not applicable. This is a mechanical device, and "ground truth" as typically understood in AI/ML clinical studies is not relevant. Mechanical testing relies on engineering standards and measurements.

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

• Not applicable. No form of adjudication is mentioned as it's not a clinical study involving human interpretation.

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 document pertains to a physical medical device (spinal implant), not an AI/ML diagnostic or assistive device. No MRMC study or human reader performance is mentioned.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering specifications and performance within defined limits of the ASTM standards mentioned.

8. The sample size for the training set

• Not applicable. There is no AI/ML component; therefore, no training set.

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

• Not applicable. There is no AI/ML component; therefore, no training set ground truth.

Summary of Non-Clinical Performance Data (as provided):

• Tests Conducted:
  • Static & dynamic compression (ASTM F2077)
  • Static & dynamic shear compression (ASTM F2077)
  • Static & dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Cage and anchor expulsion (F-04.25.05.02)
  • Corrosion testing (ASTM F2129)
• Purpose: To demonstrate substantial equivalence to predicate device(s) based on mechanical performance.
• Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

This document focuses on the regulatory clearance for a physical medical device through a 510(k) pathway, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing and comparison of technical characteristics, rather than extensive clinical efficacy studies or AI/ML performance evaluations.

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The Avenue T TLIF Cage 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous or allogenic bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.

This looks like a 510(k) submission for a medical device, specifically an intervertebral body fusion device (Avenue T TLIF Cage). The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, much of the information you've requested regarding AI algorithm performance, ground truth, expert consensus, and reader studies is not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily refers to general performance criteria through mandated ASTM standards and other non-clinical tests. It doesn't present precise numerical acceptance criteria with corresponding performance values in a direct table format as might be seen for an AI algorithm. Instead, it states that the device "is sufficient for its intended use" and "conformance to endotoxin limits."

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

This question is not applicable as there is no "test set" in the context of an AI algorithm or clinical study with human patients used for demonstrating performance in this 510(k) submission. The non-clinical tests would have their own sample sizes (e.g., number of devices tested for mechanical properties), but these are not specified in the summary.

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

This question is not applicable. There is no "ground truth" establishment in the context of medical image interpretation or diagnosis by experts as this submission is for a physical implant device, not a diagnostic AI tool.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as (3).

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 question is not applicable. This submission is for a physical medical device (spinal cage), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This question is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

This question is not applicable. For an intervertebral body fusion device, "ground truth" would relate to successful fusion or clinical outcomes, which are not assessed in this non-clinical submission. The "truth" for the bench tests is adherence to engineering specifications and performance standards.

8. The Sample Size for the Training Set:

This question is not applicable. This is not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable. This is not an AI algorithm.

Summary of Relevant Information from the Document:

• Device Type: Avenue® T TLIF Cage (Intervertebral body fusion device with integrated fixation, lumbar).
• Purpose of Submission: To demonstrate substantial equivalence to a predicate device via non-clinical performance data.
• Performance Data Provided: Non-clinical bench testing, including:
  • Finite Element Analysis
  • Dynamic compressive shear testing per ASTM F2077-11
  • Static anchoring plate expulsion testing
  • Wear testing & debris analysis
  • Corrosion testing
  • Limulus Ameebocyte Lysate (LAL) endotoxin testing
• Conclusion: The non-clinical testing demonstrated that the Avenue T TLIF Cage is sufficient for its intended use, conforms to endotoxin limits, and is substantially equivalent to legally marketed predicate devices.
• Clinical Data: "Clinical testing was not required to demonstrate substantial equivalence." (Page 5)

This document is a typical 510(k) clearance letter and summary for a Class II medical device, relying heavily on engineering and material performance tests rather than clinical trials or AI performance evaluations.

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The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity.

· Spondylolisthesis,

· Spondylolysis.

· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,

· Degeneration of the facets with instability,

· Trauma including spinal fractures and/or dislocations.

The FacetBRIDGE® System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion.

Each FacetBRIDGE® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.

This document is a 510(k) premarket notification for the FacetBRIDGE® System, specifically for a line extension that includes an additional washer design. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study of the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable/provided in this document in the context of device performance as typically defined for new medical devices requiring extensive clinical data.

Here's what can be extracted based on the provided text, and where information is missing:

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

Explanation: The document states that the purpose of the submission is to introduce a line extension and that the non-clinical performance bench testing conducted was to support substantial equivalence. The "performance" described here is in the context of ensuring the new washer design does not negatively impact existing functionality or mechanical strength. No specific quantitative performance metrics (e.g., maximum load, fatigue cycles, specific dimensional tolerances) or their corresponding acceptance thresholds are provided in this summary. Instead, a general statement of compliance or completion of these tests is made.

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

• Test Set Sample Size: Not specified. The document mentions "functional verification study utilizing sawbones" but does not give a sample size (e.g., number of sawbones tested, number of devices tested on sawbones).
• Data Provenance: Not specified. Given it's non-clinical bench testing, geographical provenance is less relevant than for clinical data. The study appears to be proprietary data from the manufacturer (LDR Spine USA, Incorporated). It is a non-clinical, prospective bench study.

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

• Number of Experts: Not applicable/provided. This was a non-clinical bench study. Ground truth in this context would typically refer to objective measurements from engineering tests rather than expert interpretation.

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

• Adjudication Method: Not applicable/provided. This was a non-clinical bench study.

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

• MRMC Study: No. This is not applicable to a non-clinical submission for a spinal implant. It's a physical medical device, not an AI or diagnostic software.

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

• Standalone Performance Study: No. This is not applicable to a physical medical device.

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

• Type of Ground Truth: For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, material standards, and verifiable physical measurements. For example, during dimensional analysis, "ground truth" would be the engineering drawings and metrology results. For endotoxin testing, it would be a validated assay and defined pass/fail criteria.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would involve specific samples for each test type mentioned.

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

• Ground Truth for Training Set Establishment: Not applicable/provided, as there is no "training set."

Summary of Device and Study Context:

This 510(k) submission, K161798 for the FacetBRIDGE® System, is for a line extension (new washer design) to an already cleared device. The regulatory strategy applied here is to demonstrate "substantial equivalence" to a predicate device (K152137), meaning the new design does not introduce new questions of safety or effectiveness. For such a submission, extensive de novo clinical trials are often not required. The clinical performance data section explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." The non-clinical data primarily consists of engineering analysis, functional verification using sawbones, and endotoxin testing, which are standard for changes to mechanical devices to confirm continued safety and performance without needing full clinical re-validation.

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