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The Streamline TL Spinal System components are non- cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: 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, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

The Streamline TL Spinal System consists of a variety of rods, polyaxial screws, transverse connectors, set screws and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, and Connecting components are comprised of Titanium Alloy per ASTM F 136. Rods are comprised of Titanium Alloy per ASTM F 136 or Cobalt Chromium Molybdenum Alloy per ASTM F 1537.

The provided text describes the 510(k) summary for the Pioneer Streamline TL Spinal System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of implants, cycles, or tests) used for the mechanical testing. It mentions "mechanical testing was presented to characterize construct and component performance."
• Data Provenance: The testing was conducted "per recognized ASTM F1717 as outlined in FDA's 'Guidance for Industry and Staff: Spinal Systems 510(k)s' issued May 3, 2004," and "additional testing was performed per internal protocols." This indicates the data is from laboratory testing (likely within the United States, given the FDA submission), not from human or animal subjects. It is prospective in the context of the device's design, as the tests were performed to support the 510(k) submission.

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

• This device is a mechanical implant, not an AI/software device that requires human expert interpretation of data or images. Therefore, the concept of "ground truth established by experts" in the context of medical imaging or clinical diagnosis is not applicable here.
• The ground truth for mechanical performance is established by the validated testing standards (ASTM F1717) and internal protocols, which are objective engineering criteria. The "experts" would be the engineers and technicians performing and interpreting these mechanical tests according to established scientific and engineering principles. Their specific qualifications (e.g., mechanical engineer, materials scientist) are not detailed but are implicit in conducting such tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert reviews of ambiguous cases, particularly for AI image analysis or diagnostic studies. This is a mechanical device submission where performance is assessed against objective engineering standards.

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, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are relevant.

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

• Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective engineering measurements and compliance with established international standards (ASTM F1717) and internal mechanical testing protocols. The "truth" is whether the device can withstand specified static and fatigue loads, and whether its components remain integrated under various stresses, performing equivalently to predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that uses a "training set." The design and manufacturing processes are informed by engineering principles, material science, and past experience with similar devices, rather than a data-driven training set.

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

• Not applicable, as there is no "training set" in the context of this device's submission.

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