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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 (T1-S2/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 0 guided to tap pilot holes
  • All other pedicle screw spinal system components and accessories lincluding 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 purpose of this traditional 510(k) is to expand the FIREFLY® indications for use to allow compatibility with all pedicle screw systems (for their cleared indications for use) meeting certain criteria and use at an additional spinal level. The FIREFLY® design is the same as was originally cleared in K143222.

The provided document, K162419, describes the substantial equivalence determination for the "FIREFLY® Pedicle Screw Navigation Guide". While it mentions that "Additional cadaveric accuracy testing of the FIREFLY® Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended," it does not fully detail the acceptance criteria or the specifics of the study in a manner that allows for a comprehensive answer to all parts of your request.

Here's an attempt to answer based on the available information, noting where details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document states that acceptance criteria were met but does not explicitly list the specific quantitative acceptance criteria. It only generally refers to "accuracy."

Reported Device Performance: The document states that "Additional cadaveric accuracy testing... demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended." Specific performance metrics (e.g., mean angular deviation, mean translational error) are not provided in this document.

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

• Sample Size for Test Set: The document simply mentions "Additional cadaveric accuracy testing" without specifying the number of cadavers, pedicles, or screws tested.
• Data Provenance: "Cadaveric accuracy testing" implies the data was derived from cadaveric studies. The country of origin is not specified but given the FDA submission, it's likely a study conducted in the USA or adhering to US standards. It's inherently a retrospective analysis of the device's accuracy on cadaveric specimens.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the cadaveric study. For cadaveric studies involving pedicle screws, ground truth often involves post-operative CT scans or direct measurement by skilled researchers/surgeons.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. This type of study is more common for diagnostic imaging AI systems to assess human performance with and without AI assistance. This device is a surgical navigation guide.

6. Standalone (Algorithm Only) Performance Study

The document describes "accuracy testing," which is inherently a standalone performance evaluation of the device as it guides surgical instruments. However, the exact methodology and quantitative results for this standalone performance are not provided beyond the statement that acceptance criteria were met.

7. Type of Ground Truth Used

For "cadaveric accuracy testing," the ground truth typically involves:

• Post-operative imaging: High-resolution CT scans of the cadaveric spine with inserted pedicle screws, where the actual position of the screws relative to the pedicle canal is measured.
• Direct measurement: Physical dissection and measurement, though less common for pedicle screw accuracy compared to imaging.

The document does not explicitly state how the ground truth was established, but the context of pedicle screw accuracy testing points to methods that objectively verify screw placement against anatomical goals.

8. Sample Size for the Training Set

The document describes a "Pedicle Screw Navigation Guide," which is a mechanical guidance device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense. The device's design is based on patient-specific CT imaging for pre-surgical planning, but this is a process of individual case design, not an algorithm being "trained" on a large dataset. Therefore, the concept of a training set sample size is not applicable here.

9. How Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of mechanical surgical navigation guide.

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