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The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

• I ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• 2. spondylolisthesis,
• 3. trauma (i.e., fracture or dislocation),
• 4. spinal stenosis,
• 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• 6. tumor.
• 7. pseudoarthrosis, and
• 8. failed previous fusion
     The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.

The provided text is a 510(k) summary for a modification to the Firebird Spinal Fixation System, specifically the addition of a "Side-loading Body." This document describes a medical device and its regulatory submission, not a study involving AI or diagnostic performance metrics typically found in acceptance criteria for AI-powered devices.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, and training set information) are not applicable to this document as it pertains to a mechanical medical device and its physical performance testing for substantial equivalence, not a diagnostic or AI-based system.

Here's an attempt to answer the applicable questions based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Mechanical Device Context)

1. Sample size used for the test set and the data provenance: The document states "Mechanical testing... was conducted in accord with ASTM standards." ASTM standards for mechanical testing typically specify the number of samples required for each test (e.g., fatigue, static bending, axial pull-out). However, the specific sample sizes used for these tests are not provided in this 510(k) summary. Data provenance is implied to be from laboratory testing performed by or for Blackstone Medical, Inc. or its contract manufacturer. This is by nature prospective testing, as it's performed to evaluate the new component.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For mechanical performance testing of a spinal implant, "ground truth" is established by physical measurements and engineering analyses based on established ASTM standards, not by expert medical review.

3. Adjudication method: This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies where human disagreement needs resolution. Mechanical testing results are objective measurements.

4. 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: This is not applicable. This document describes a mechanical medical device, not an AI or diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. This refers to AI algorithm performance.

6. The type of ground truth used: For mechanical equivalence, the "ground truth" is defined by the performance specifications and physical characteristics of the legally marketed predicate devices and the established ASTM testing standards. The new device's performance is compared against these benchmarks to determine substantial equivalence.

7. The sample size for the training set: This is not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device.

8. How the ground truth for the training set was established: This is not applicable for the same reasons as above.

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