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The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Streamline MIS Spinal Fixation System is a temporary, multiple component cannulated pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct through an open or percutaneous approach. The implant components include rods, extended tab cannulated polyaxial pedicle screws, crosslinks, and locking set screws that are fabricated from titanium alloy (ASTM F136) and provided nonsterile. The components are available in various sizes to accommodate differing patient anatomy. The system is attached to the pedicles by means of screws to the posterior, noncervical spine. The spinal construct is completed by connecting the screws with titanium alloy rods. Crosslinks can be used if additional stabilization is necessary.

The Streamline MIS Spinal Fixation System includes instrumentation to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Class I manual instruments are also included.

I am sorry, but based on the provided text, there is no information regarding the acceptance criteria, device performance, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or the specific type of ground truth used for the Streamline MIS Spinal Fixation System.

The document is a 510(k) premarket notification for a medical device (spinal fixation system) and primarily focuses on demonstrating substantial equivalence to a predicate device. It highlights:

• Device Description and Indications for Use: What the device is and what it's used for.
• Comparison to Predicate: Stating that the new device has the same intended use, technological characteristics, operating principle, design features, performance, base materials, and shelf life as the predicate device(s).
• Summary of Mechanical Performance Data: Mentions "non-standard testing" for specific characteristics like torque to failure for instrumentation drivers, but does not provide acceptance criteria or specific performance results. It concludes that this testing "supports that Streamline MIS Spinal Fixation System is substantially equivalent to the predicate device for safety and efficacy."
• Summary of Magnetic Resonance (MR) Safety Evaluation: Mentions standard testing (ASTM F2503-13, ASTM F2502-15, ASTM F2213-17 and ASTM F2182-11a) to determine MR labeling as 'MR Conditional', but again, no specific acceptance criteria or performance metrics are listed.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study setup for evaluating an AI/algorithm-based device from this document. The document describes a mechanical spinal fixation system, not an AI or software-as-a-medical-device that would typically involve the kind of performance studies you are asking about (e.g., using experts, ground truth, training/test sets for an algorithm).

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