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The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in 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:

• 1. 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),
• spinal stenosis, 4)
• 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• 6. tumor,
• 7. pseudoarthrosis, and
• 8. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.

This document is a 510(k) Premarket Notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion. It indicates that the submission is for an expansion of a previously cleared system, focusing on adding new non-pedicle components (Hooks and Iliac Connectors). Therefore, the "device" in question refers to these additional components for the existing Firebird Spinal Fixation System.

It's important to note that this is a 510(k) submission, which typically demonstrates substantial equivalence to a predicate device rather than independent proof of safety and effectiveness through a clinical trial with specific performance criteria for AI/software-as-a-medical-device. The "performance data" here refers to mechanical testing for the new components.

Here's an analysis based on the provided text, recognizing the context of a spinal implant device and not an AI/software device:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" for this device:

For spinal fixation systems like this, acceptance criteria in a 510(k) context are typically demonstrated through:

• Mechanical Testing: Showing that the new components meet established standards for strength, durability, and resistance to wear, and perform comparably to legally marketed predicate devices. The document specifically mentions static compression bending, static torsion, and dynamic compression bending.
• Biocompatibility: (Though not explicitly detailed in this summary, it's an inherent requirement for implantable devices.)
• Design Rationale & Risk Analysis: Demonstrating that the design is appropriate for its intended use and that potential risks have been mitigated.
• Demonstration of Substantial Equivalence: The overarching goal of a 510(k) is to prove the device is as safe and effective as a legally marketed predicate device.

2. Sample Size for Test Set and Data Provenance

This document describes mechanical testing of physical implants, not a clinical study involving a "test set" of patients or data in the way an AI/software device would. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission. Mechanical tests would use a certain number of device components but this is not specified as a "sample size" in this document.

3. Number of Experts and Qualifications for Ground Truth

Again, this is a mechanical device submission, not an AI/software device. There were no experts used to establish "ground truth" in the clinical sense for a test set. The "ground truth" for mechanical testing is derived from established engineering standards and comparison to predicate device performance data (often from similar mechanical tests or published data).

4. Adjudication Method

Not applicable. There was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission is for a physical spinal implant, not an AI/software device that would assist human readers in diagnosis or analysis.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device; there is no algorithm or standalone software performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this device's performance demonstration relies on:

• Engineering Standards: Established international and national standards for spinal implant mechanical testing.
• Predicate Device Performance Data: Mechanical test results from the identified predicate devices (e.g., Firebird Spinal Fixation System Cobalt-Chrome Rods, Blackstone Pedicle Screw System, Synthes Universal Spine System, DePuy Acromed systems). The performance of the new components must demonstrate equivalence to these established predicate devices.

8. Sample Size for the Training Set

Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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