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The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (TI-S2/S2Al and ilium) intended for fusion, with the additional conditions listed below:

• . Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion ●
• Pedicle screw is intended to be inserted into a pilot hole ●
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ●
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• . Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o
  • Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be O quided to tap pilot holes
  • All other pedicle screw spingl system components and accessories (including non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.

The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.

Patient-Specific Bone Models may also be provided.

The provided text describes the 510(k) summary for the FIREFLY® Pedicle Screw Navigation Guide (K181399). Based on the text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document simply states "Additional cadaveric accuracy testing" was performed. It does not specify the number of cadavers or pedicles used in this test set.
• Data Provenance: The study was "cadaveric accuracy testing," implying it was conducted on human cadavers. The country of origin and whether it was retrospective or prospective are not mentioned.

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

This information is not provided in the document. The text does not describe how ground truth was established for the cadaveric accuracy testing, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance.
• Effect size: Not applicable, as no such study is described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The FIREFLY® Pedicle Screw Navigation Guide is a physical device intended to guide surgical instruments. It is not an AI algorithm in the traditional sense that would have "standalone" performance without human-in-the-loop. The "performance data" section refers to cadaveric accuracy testing of the physical guide's ability to direct instrument placement, which inherently involves human surgeons using the device.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the cadaveric accuracy testing. For such a device, ground truth would typically be established by precise measurements of actual screw placement in relation to planned trajectories, possibly using highly accurate imaging techniques (e.g., post-operative CT scans with fiducial markers, or direct anatomical measurements). However, the specific method is not detailed.

8. Sample Size for the Training Set

The document states, "The FIREFLY® uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data." This indicates that each guide is patient-specific and generated from individual patient CT data. There isn't a "training set" in the conventional machine learning sense for the device itself, as it's a patient-specific physical guide based on pre-operative imaging rather than a learned algorithm trained on a large dataset.

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

As explained above, there isn't a traditional "training set" for an AI algorithm here. The "training" for the patient-specific guide comes from the individual patient's CT imaging data and the surgeon's presurgical planning. The "ground truth" for this process would be the surgeon's intended screw trajectory based on their anatomical assessment from the CT.

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