(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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.