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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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The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. 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 of 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.

The 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.

The Streamline MIS Spinal Fixation System is a multiple component 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, polyaxial pedicle screws with extended tabs, crosslinks, and locking set screws. 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.

All implant components of the Streamline MIS Spinal Fixation System are manufactured from the implant grade Ti 6Al/4V ELI Alloy, Grade 23 (ASTM F136).

The Streamline MIS Spinal Fixation System components are used with the Streamline TL System locking set screws and crosslinks, and the Quantum Spinal System Crosslinks.

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.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details as requested:

Device: Streamline MIS Spinal Fixation System (Pedicle Screw System)

This document describes a 510(k) premarket notification for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria for performance metrics (like sensitivity/specificity for AI). Therefore, the "acceptance criteria" here refer to the standards for demonstrating substantial equivalence, and the "study" refers to the pre-clinical performance testing against those standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of human subject testing. The "test set" here refers to the physical device components tested in pre-clinical mechanical performance studies. The document does not specify the number of individual components or constructs tested for ASTM F1717.
• Data Provenance: The studies were pre-clinical performance tests conducted to physical samples of the device. The data is thus generated in a lab setting, not from patient data, and is therefore neither retrospective nor prospective. The location of the testing is not explicitly stated but is implied to be performed by or for the manufacturer (Pioneer Surgical Technology, Inc., Marquette, MI, USA).

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

Not applicable. "Ground truth" in this context refers to the outcome of physical/mechanical tests based on established engineering standards (ASTM F1717), not expert interpretation of medical images or patient outcomes. The evaluation is based on objective measurements from mechanical testing machines.

4. Adjudication Method for the Test Set

Not applicable. This was a pre-clinical mechanical performance study against a standard, not a study requiring adjudication of expert opinions.

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 510(k) submission for a non-AI, mechanical spinal fixation system. No human reader studies, AI assistance, or MRMC studies were conducted or are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by standardized mechanical testing protocols (ASTM F1717). This involves objective physical measurements of the device's strength, stiffness, and durability under compression, bending, and torsion, which are then compared to the performance of predicate devices or established minimum standards.

8. The Sample Size for the Training Set

No "training set" in the context of an AI algorithm is applicable. This is a mechanical device.

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

Not applicable, as there is no training set for an AI algorithm.

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