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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:

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),
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 document describes the K092624 premarket notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System with the addition of a Cobalt Chrome Rod. This is a medical device submission, and as such, the concept of "acceptance criteria" and "device performance" as it might apply to software or AI algorithms is not directly applicable in the same way. Instead, the "acceptance criteria" for a medical device like this is typically demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.

Here's a breakdown based on the provided text, adapted to the context of a medical hardware device:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For medical devices, "sample size" in this context typically refers to the number of devices or components tested. ASTM standards for medical devices usually specify the required number of samples for each test type to achieve statistical significance.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that the submission is to the FDA (USA), it is reasonable to infer the testing was likely conducted in the US or by a lab adhering to US standards. Mechanical testing on medical devices is inherently prospective, as it involves newly produced components subjected to defined test protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable. For mechanical testing of a medical device, "ground truth" is established by the specifications of the ASTM standards themselves and the objective measurements obtained from standardized testing equipment, not by a panel of human experts. Expert clinical opinion would be relevant in the initial design and indication definition, but not in validating the mechanical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable. Mechanical testing of physical medical devices does not involve human adjudication in the way clinical studies or image analysis might. The results are based on objective physical measurements and adherence to pre-defined test protocols.

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

This question is not applicable. The device is a spinal fixation system (hardware), not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant to this submission.

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

This question is not applicable. The device is a spinal fixation system, which is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical testing of this device is established by objective physical measurements (e.g., force, displacement, cycles to failure) in accordance with recognized industry standards (ASTM standards). These standards define the criteria for acceptable performance (e.g., fatigue life, strength) for spinal fixation systems.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing for a medical device like a spinal fixation system. The device's performance is evaluated against engineering standards and comparison to a predicate device.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this type of device submission.

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