(195 days)
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the. treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR System 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.
The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
The MaxFuse VBR System is a radiolucent, multilevel corpectomy system with VBR devices in a variety of footprint options, height options, and lordotic angle options to accommodate a wide variety of patient anatomy. The MaxFuse VBR devices may be used with bone graft.
This K131724 510(k) premarket notification describes the MaxFuse VBR System, a radiolucent, multilevel corpectomy system used in the thoracolumbar spine. The device is a vertebral body replacement (VBR) system indicated for replacing diseased vertebral bodies due to tumors, achieving anterior decompression, restoring height to collapsed vertebral bodies, and treating thoracic and lumbar spine fractures. It is intended for use with supplemental internal fixation systems.
Here's an analysis of the acceptance criteria and the study conducted for the device:
Acceptance Criteria and Device Performance
This submission focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing rather than clinical study. The acceptance criteria are implicit in meeting the standards of the specified ASTM tests, showing "equivalent results" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static and Dynamic Axial Compression Bending (ASTM F 2077) | Substantial equivalence established through side-by-side testing to legally marketed predicate devices, with "equivalent results." |
| Static Subsidence (ASTM F 2267) | Substantial equivalence established through side-by-side testing to legally marketed predicate devices, with "equivalent results." |
| Static Expulsion (Draft Z8423Z, Submitted to ASTM F04.25.02.02) | Substantial equivalence established through side-by-side testing to legally marketed predicate devices, with "equivalent results." |
No clinical study to demonstrate "device performance" in terms of patient outcomes or biological response is mentioned in this summary. The performance data provided is purely mechanical.
Study Details:
This submission relies on bench testing to demonstrate substantial equivalence, not a clinical study involving human subjects or artificial intelligence. Therefore, many of the requested categories related to clinical trials or AI performance are not applicable.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of human subjects or data records. Rather, it refers to the number of physical devices or constructs tested according to the ASTM standards. The specific number of devices tested for each standard (ASTM F 2077, ASTM F 2267, Draft Z8423Z) is not provided in this summary.
- Data Provenance: The data is from laboratory bench testing of the MaxFuse VBR System and predicate devices. No country of origin is specified for these tests, but they were conducted to U.S. ASTM standards by the manufacturer (Pioneer Surgical Technology, Inc., U.S.). This is a form of prospective testing tailored for regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is defined by the objective mechanical measurements dictated by the ASTM testing standards. The standards themselves are developed by expert consensus within ASTM, but no individual experts are cited for establishing ground truth for this specific device's test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was mechanical bench testing against established performance standards, not a diagnostic or clinical assessment requiring adjudication.
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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 a physical implant, not an AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on objective mechanical measurements according to established ASTM standards (ASTM F 2077, ASTM F 2267, and Draft Z8423Z). These standards define acceptable performance metrics for static and dynamic axial compression bending, static subsidence, and static expulsion.
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The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant.
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How the ground truth for the training set was established: Not applicable, as there is no training set mentioned or implied.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.