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.

Device Description

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.

AI/ML Overview

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.

Summary

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October 26, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Mighty Oak Medical, Inc. Mr. Mark A. Wylie VP of Quality and Regulatory 750 W. Hampden Avenue, Suite 120 Englewood, Colorado 80110

Re: K220132

Trade/Device Name: FIREFLY® Cervical Navigation Guide Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: QSD Dated: September 22, 2022 Received: September 26, 2022

Dear Mr. Wylie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220132

Device Name FIREFLY® Cervical Navigation Guide

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

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FIREFLY® Cervical Navigation Guide

Submitter:

Mighty Oak Medical, Inc. 750 W. Hampden Ave., Suite 120 Enalewood, CO 80110 (720) 398-9703

Mark A. Wylie, VP of Quality and Regulatory Contact: Date Prepared: 14JAN2022

Device

Trade Name:	FIREFLY® Cervical Navigation Guide
Common Name:	Posterior Cervical Screw Placement Guide
Device Classification:	Class II
Regulation, Name:	21 CFR 888.3075, Posterior Cervical Screw System
Device Product Code:	QSD

Type of 510(k)

Original Submission: Traditional

Predicate Device(s):

FIREFLY® Cervical Navigation Guide

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K153631	NKG	Virage OCT Spinal System	Zimmer
Reference Device
K181399	PQC	FIREFLY Pedicle Screw Navigation Guide	Mighty Oak Medical

Description

Patient-Specific Bone Models are also provided.

The primary purpose of the 510|k) is to receive clearance from the Food and Drug Administration ("FDA" or "the Agency") regarding the above requests.

The FIREFLY® Cervical Navigation Guide design is the sriginally cleared FIREFLY® Pedicle Screw Navigation Guide in K143222, K162419, and K181399.

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Indications for Use

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 screws in the 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 deferrined on a preoperative CT/CTA scan.

The FIREFLY® Cervical Navigation Guide system is compatible with FDA cleared, leagly marketed, posterior cervical screw systems (and their respective compatible 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 auglified compatible OEM posterior cervical screw system faps may be used to visually quide 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 FREFLY® 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 Power drill 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.

Materials

The patient-contacting components of the FIREFLY® Cervical Navigation Guide are manufactured from a polymer powder for use in additive manufacturing (HP High Reusability PA12).

Performance Data

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.

Technological Characteristics

The subject FIREFLY® Cervical Navigation Guide possesses the same technological characteristics as the predicate and reference devices. These include:

Creation of a pilot hole for insertion of a posterior cervical screw
. Performance
Manufacturing process ●
Sterilization .
Biocompatible materials
. Basic design

Technological characteristics which are different have been supported with descriptive information and/or performance data. Therefore the fundamental scientific technology of FIREELY® is the same as the previously cleared device.

Conclusion

The FIREFLY® Cervical Navigation Guide possesses the same intended use and technological characteristics as the predicate devices. Therefore the FREFLY® Cervical Navigation Guide is substantially equivalent for its intended use.

Regulation Number and Section

§ 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.