(281 days)
The FIREFLY® Cervical Navigation Guide system is intended to provide mechanical guidance for the preparation and drilling of pilot holes for the placement of posterior cervical spine (C1-C7) and the upper thoracic spine (T1-T3). Pilot holes are created using the FIREFLY® Cervical Navigation Guide in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) during open, posterior spinal fixation procedures, on skeletally mature patients, that are intended for fusion. The patient's pedicles, pars, or lateral masses must be dimensionally adequate to safely accommodate a posterior cervical screw, as determined on a preoperative CT/CTA scan.
The FIREFLY® Cervical Navigation Guide system is compatible with FDA cleared, legally marketed, posterior cervical screw systems (and their respective components) that are specified in the precautions. Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm each pedicle's integrity. Only qualified compatible OEM posterior cervical screw system taps may be used to visually guide the tapping of pilot holes. All other posterior cervical screw system components and accessories (including non-visually guided taps) are to be used, after removal of the FIREFLY @ Cervical Navigation Guide, as directed by the posterior cervical screw system's instructions for use.
The FIREFLY® Cervical Navigation Guide system is only compatible with consoles systems (attachments and burs) listed in the precautions.
This system (guide, bone model, drill bit, and depth stop) are intended for single use only.
The FIREFLY® Cervical Navigation Guide is intended to assist in the accurate placement of posterior cervical screws. It consists of single-use components designed for treatment of a specific patient.
The FIREFLY® Cervical Navigation Guide uses Patient-Specific Cervical 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/CTA imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) for placing screws following the Approved Patient-Specific Surgical Plan.
Patient-Specific Bone Models are also provided.
The provided text describes a 510(k) premarket notification for the FIREFLY® Cervical Navigation Guide. It outlines the device's indications for use, technological characteristics, and a summary of performance data from cadaveric accuracy testing.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "Cadaveric accuracy testing of the FIREFLY® Cervical Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Cervical Navigation Guide's performance is adequate to perform as intended." However, the specific quantitative acceptance criteria and the corresponding reported device performance values (e.g., accuracy in angle or translation) are not explicitly provided in the document.
Therefore, the table cannot be fully constructed.
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: Not explicitly stated in the document. The text only mentions "Cadaveric accuracy testing." It does not specify the number of cadavers or the number of pilot holes tested.
- Data Provenance: The study was "Cadaveric accuracy testing." The country of origin is not specified, and it is a type of prospective study on cadavers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not explicitly stated.
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
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described. The device is a "Cervical Navigation Guide" which provides mechanical guidance for instrument placement. It is not an AI-assisted diagnostic or interpretation tool for human readers but rather a surgical guidance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is less directly applicable to a mechanical surgical navigation guide. The "performance" described is the accuracy of the guide itself in directing instruments. Since it's a mechanical guide, its function is inherently "standalone" in guiding the physical instrument, although a human surgeon is always "in the loop" operating the instruments through the guide. The cadaveric testing assesses the mechanical accuracy of the guide as intended.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the cadaveric accuracy testing, the ground truth would typically be established by highly precise measurements of the actual pilot hole trajectory and depth in relation to the pre-surgically planned trajectory, often using imaging (e.g., post-procedure CT scans) and/or metrology. The document does not specify the exact method for ground truth establishment.
8. The sample size for the training set
- The document describes a cadaveric performance study, not a machine learning model that relies on a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
- As this is not a machine learning device, this question is not applicable.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.