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.

Device Description

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.

AI/ML Overview

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.

Summary

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October 3, 2018

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

Re: K181883

Trade/Device Name: FIREFLY® Midline Navigation Guide Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: POC Dated: July 11, 2018 Received: July 13, 2018

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 Mav 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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K181883 Device Name

FIREFLY® Midline Navigation Guide

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) X

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

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FIREFLY® Midline Navigation Guide

Submitter:

Mighty Oak Medical750 W. Hampden Ave., Suite 120Englewood, CO 80110(720) 398-9703
Contact:	Mark A. Wylie, VP of Quality and Regulatory
Date Prepared:	11 July 2018
Device
Trade Name:	FIREFLY® Midline Navigation Guide
Common Name:	Pedicle Screw Placement Guide
Device Classification:	Class II
Regulation, Name:	21 CFR 888.3070, Pedicle screw spinal system
Device Product Code:	PQC

Predicate Device(s):

FIREFLY® Midline Navigation Guide

Primary Predicate:

K162419 (S.E. 10/28/2016)

Description

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.

Patient-Specific Bone Models are also provided.

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

The FIREFLY® Midline Navigation Guide design is the originally cleared FIREFLY® Pedicle Screw Navigation Guide in K143222 and K162419.

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Indications for Use

The FIREFLY® Midline 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 (T10-S2) intended for fusion, with the additional conditions listed below:

o Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
o Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
Pedicle screw's longitudinal axis matches the direction of insertion
o 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
o 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® o Midline Navigation Guide to confirm pedicle integrity
- All other pedicle screw spinal system components and accessories (including non o quided taps) are to be 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.

Materials

The patient-contacting components of the FIREFLY® Midline Navigation Guide are manufactured from epoxy resin (Accura ABS White SL 7810).

Performance Data

Cadaveric accuracy testing of the FIREFLY® Midline Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Midline Navigation Guide's performance is adequate to perform as intended.

Technological Characteristics

The subject FIREFLY® Midline Navigation Guide possesses the same technological characteristics as the predicate device. These include:

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 FIREFLY® is the same as the previously cleared device.

Conclusion

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

Regulation Number and Section

§ 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.