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The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

The JASPER Spinal Fixation System II is indicated for the following:

• Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Stenosis
• Pseudoarthrosis
• Failed previous fusion

The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the JASPER Spinal Fixation System II is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The JASPER Spinal Fixation System II is a top-loading multiple component, posterior(thraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System II will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

All products are made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.

The provided text is a 510(k) summary for a medical device (The JASPER Spinal Fixation System II) and does not contain information about acceptance criteria or a study proving that a device meets such criteria, especially regarding AI/ML performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, material, scientific technologies, and intended use. It explicitly states: "No new mechanical testing was performed as no non-previously cleared components were added to the JASPER Spinal Fixation System II." This indicates that the submission relies on the prior clearances of its predicate devices and does not present new performance data for the device itself or any AI/ML component.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

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The JASPER Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

The JASPER Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Stenosis
• Pseudoarthrosis
• Failed previous fusion

The JASPER Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the JASPER Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The JASPER Spinal Fixation System is a top-loading multiple component, posterior(thoraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

Materials : All products are made of titanium alloy(Ti-6AI-4V ELI, ASTM F136)and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.

The provided text is a 510(k) summary for the JASPER Spinal Fixation System. It describes the device, its indications for use, and a comparison to predicate devices, along with a brief mention of performance testing. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

Here's a breakdown of why this information is missing:

• Acceptance Criteria Table & Reported Performance: The document states that "Bench testing results demonstrate that JASPER Spinal Fixation System performs equivalently to the predicates in static compression bending, static torsion and fatigue compression bending construct testing (in accordance with ASTM F1717-15) and static and torsional gripping capacity and transverse moment testing (in accordance with ASTM F1798)." This indicates that performance tests were conducted against specific standards (ASTM F1717-15 and ASTM F1798), and the device's performance was found to be "equivalently" to predicates. However, the exact numerical acceptance criteria, the specific numerical results obtained for the JASPER system, or the numerical performance of the predicate devices are not provided. Therefore, a table of acceptance criteria and reported device performance cannot be generated from this text.

• Sample Size for Test Set and Data Provenance: The document mentions "bench testing" but does not specify the sample size (e.g., number of constructs or individual components tested) nor the provenance of any data (as it's a mechanical device, data provenance like country of origin or retrospective/prospective is not applicable in the same way as for AI/diagnostic devices).

• Number of Experts, Qualifications, and Adjudication Method: These points are relevant for studies involving human interpretation or clinical data (e.g., medical imaging devices). The JASPER Spinal Fixation System is a mechanical implant. The performance assessment described is physical bench testing against engineering standards. Therefore, these categories are not applicable to the information provided.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC study is typically performed for diagnostic devices (especially those involving AI assistance) where human readers evaluate cases with and without algorithmic aid. This is not applicable to a spinal fixation system, which is a physical implant.

• Standalone (Algorithm Only) Performance: Similar to the above, this is relevant for AI algorithms. The JASPER Spinal Fixation System is a physical device, not an algorithm.

• Type of Ground Truth Used: For mechanical testing, the "ground truth" would be the engineering specifications and the physical measurements obtained during the tests. The document refers to "ASTM F1717-15" and "ASTM F1798" as the standards used, which implicitly define the framework for establishing whether the device performs acceptably.

• Sample Size for Training Set and How Ground Truth for Training Set Was Established: These questions are specific to machine learning/AI models. The JASPER Spinal Fixation System is a mechanical medical device, not an AI product. Therefore, these questions are not applicable to the provided document.

In summary, the document states that the device meets acceptance criteria by performing "equivalently" to predicate devices based on specific ASTM standards for mechanical testing. However, it does not provide the detailed quantitative results or specific criteria that would allow for a comprehensive answer to your questions in the desired format.

Ask a specific question about this device