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CERVICAL INTERBODY FUSION DEVICE

When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.

LUMBAR INTERBODY FUSION DEVICE

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

VERTEBRAL BODY REPLACEMENT

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of TI-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique.

This document is a 510(k) premarket notification for the "Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System". It concerns the clearance for the use of allogenic bone graft with the existing C-Plus cervical intervertebral body fusion device.

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

This document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, the basis for clearance is substantial equivalence to a predicate device (Pioneer IBF/VBR System K133455) and a literature analysis. The "performance" in this context refers to demonstrating that the expanded indication (use of allogenic bone graft) poses no new risks and is equivalent to the established performance with autogenous bone graft.

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

• Sample size for the test set: Not applicable and not explicitly stated. The submission relies on a "literature analysis of published clinical data" rather than a new test set generated for this 510(k). The literature analysis would have encompassed various studies, each with its own sample size.
• Data provenance: Not specified in terms of country of origin or whether the individual studies in the literature analysis were retrospective or prospective. The submission only states it's "published clinical data."

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 submission relies on a literature analysis, not a new study with a ground truth established by experts specifically for this submission. The "ground truth" (clinical outcomes) would have been established within the original published studies by the researchers and clinicians involved.

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

Not applicable. No new test set or adjudication process was performed for this 510(k) submission.

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 is a spinal implant device, not an AI/imaging device.

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

Not applicable. This is a spinal implant device, not an AI/imaging device.

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

The "ground truth" implicitly referred to in the literature analysis would be the clinical outcomes data from previously published studies on cervical interbody fusion devices using allogenic bone graft. This would include fusion rates, pain reduction, adverse events, etc.

8. The sample size for the training set

Not applicable. No new algorithm or model was trained for this submission. The device is a physical implant.

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

Not applicable. No new algorithm or model was trained for this submission.

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The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.

The provided text is a 510(k) Summary for a medical device called the "Reliance VBS System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously marketed devices, often through comparison of design, materials, and intended use.

*Crucially, this document does not describe acceptance criteria, performance metrics, or any study results typical of an AI/ML or diagnostic device.

The Reliance VBS System is a spinal implant (a spacer to replace a portion of a vertebral body). Its "performance" is primarily assessed through its design, materials, and mechanical properties, not through a clinical study that would have a "test set," "ground truth," or "expert readers" in the way one might evaluate an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information in the table or the detailed points about studies, sample sizes, and ground truth establishment, as these concepts are not applicable to the information contained in this 510(k) summary for a physical orthopedic implant.

The document states:

• Device Description: The Reliance VBS device is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. It may be made of PEEK with Tantalum markers, or made of Titanium alloy.
• Intended Use/Indications for Use: For use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression, restore height, and biomechanical integrity. It is to be used with a cleared supplemental fixation device and bone graft.
• Substantial Equivalence: The device is stated to be substantially equivalent to several legally marketed predicate devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

To reiterate, this is a hardware device approval, not a software or AI approval. Therefore, the concepts requested in the prompt (acceptance criteria for a study, device performance results, sample sizes for test/training sets, ground truth, expert adjudication, MRMC comparative effectiveness studies, and standalone algorithm performance) are not present in this type of regulatory submission and are not relevant to the approval of this spinal implant.

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The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following partial replacement of a diseased vertebral body.

The Pioneer Vertebral Spacer is a medical device and its predicate device is K043206.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This 510(k) submission primarily relies on bench testing (mechanical and chemical information) and demonstrated substantial equivalence to a predicate device (K043206).
• The document does not mention a "test set" in the context of clinical data, human subjects, or image-based evaluations. Therefore, there is no sample size for a test set and no data provenance in terms of country of origin or retrospective/prospective human data.

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

• Not applicable. There is no mention of a test set involving expert review of clinical cases.

4. Adjudication method for the test set:

• Not applicable. There is no mention of a test set involving adjudication.

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:

• No MRMC study was done. This device is a passive vertebral spacer, not an AI-powered diagnostic or assistive tool.

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

• No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established through engineering principles, material science testing (mechanical and chemical data), and comparison to the characteristics and performance of a legally marketed predicate device. There is no biological or diagnostic ground truth (like pathology or outcomes data) directly mentioned as part of the submission for this type of device.

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 there is no training set for an AI/ML algorithm.

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