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510(k) Data Aggregation
(82 days)
The FIREFLY® Midline Navigation Guide can be used with any 510(k) clearly marketed, pedicle screw spinal system (for its cleared indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures (T10-S2) intended for fusion, with the additions listed below:
- o 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 pedicle screw spinal system instruments may be used with the FIREFLY® Midline Screw Navigation Guide
- Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used with the FIREFLY® Midline Navigation O Guide to confirm pedicle integrity
- All other pedicle screw spinal system components and accessories [including non-guided taps] are to be O used, after removal of the FIREFLY® Midline Navigation Guide, as directed by the pedicle screw spinal system's instructions for use
This device is intended for single use only.
The FIREFLY® Midline 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.
The FIREFLY® Midline Navigation Guide uses Patient-Specific 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 Surgical Plan.
Patient-Specific Bone Models are also provided.
Here's a breakdown of the acceptance criteria and study information for the FIREFLY® Midline Navigation Guide, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not explicitly stated in terms of specific numerical thresholds for accuracy (e.g., angular deviation, translational error). | "The results demonstrated that the acceptance criteria were met and that the FIREFLY® Midline Navigation Guide's performance is adequate to perform as intended." | The document confirms that acceptance criteria were met, but does not detail the specific numerical values of these criteria or the test results. |
2. Sample Size and Data Provenance for Test Set
- Sample Size Used for Test Set: Not specified. The document only mentions "Cadaveric accuracy testing."
- Data Provenance: Cadaveric. The document does not specify the country of origin or if the cadavers were retrospectively or prospectively selected.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not specified. The document does not mention the involvement of experts in establishing ground truth for the cadaveric accuracy testing. It's likely that the ground truth for pedicle screw placement in cadaveric studies is often established by comparing the guided placement to anatomical landmarks or established safe zones, which may involve expert anatomical assessment, but the details are not provided.
4. Adjudication Method (Test Set)
Not specified. No information is provided regarding any adjudication method used for the cadaveric accuracy testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The device is a "Navigation Guide," implying it assists in physical placement rather than image interpretation by human readers.
6. Standalone Performance Study (Algorithm Only)
Yes. The "Cadaveric accuracy testing" appears to be a standalone performance study of the device's ability to guide instruments accurately, without human-in-the-loop performance being assessed in a comparative manner with human readers. The device guides the surgeon to create pilot holes, meaning its performance is inherently linked to its interaction with a surgeon, but the "accuracy testing" usually refers to the precision of the guide itself.
7. Type of Ground Truth Used
The type of ground truth used for the cadaveric accuracy testing is implicitly anatomical/physical measurement. The device guides instrument placement, and "accuracy testing" in this context would likely involve measuring the deviation of the guided trajectories from the presurgically planned trajectories or known correct anatomical paths within the cadaveric pedicles.
8. Sample Size for Training Set
The document does not mention a training set. The FIREFLY® Midline Navigation Guide uses "Patient-Specific Guides" based on "the patient's CT imaging data" and "trajectories chosen presurgically, by the surgeon." This suggests a patient-specific design approach rather than a machine learning model that requires a large training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set for an AI/machine learning model is described. The device's operation is based on pre-surgical planning by a surgeon using patient CT data, not on a trained algorithm.
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(56 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "the acceptance criteria were met" but does not detail what those criteria specifically were. | The results of "Additional cadaveric accuracy testing" demonstrated that the device met its unspecified acceptance criteria and its performance is adequate to perform as intended. |
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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