The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.

Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be 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.

Device Description

The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system 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.

AI/ML Overview

The provided text describes the FIREFLY™ Pedicle Screw Navigation Guide and its performance data. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information on ground truth establishment, expert consensus, or MRMC studies. The document is a 510(k) summary for FDA clearance, which typically presents a high-level overview rather than detailed scientific study breakdowns.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Accuracy	Not specified	Met acceptance criteria
Sterilization stability	Not specified	Met acceptance criteria

Missing Information: The specific numerical or qualitative acceptance criteria for accuracy and sterilization stability are not detailed in this document.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Cadaveric accuracy and sterilization stability testing."

Sample Size for Test Set: Not specified.
Data Provenance: Cadaveric testing. (Country of origin is not specified, and it's a prospective study as it was performed for this specific device).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document describes accuracy testing, but not a comparison of human readers with and without AI assistance to measure improvement effect size.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "Pedicle Screw Navigation Guide," which implies it is a physical guide used by a surgeon during surgery. It is not an AI algorithm in the traditional sense that would have "standalone" performance independent of human interaction in the operating room. Therefore, the concept of "standalone algorithm performance" as typically applied to AI image analysis is not relevant here. The accuracy refers to the guide's precision in directing the surgical instruments.

7. The Type of Ground Truth Used

Ground Truth: For accuracy, the "ground truth" would likely be the actual placement of the pilot holes or screws in the cadavers, as measured post-procedure (e.g., via CT scanning and comparison to pre-operative plans). This is implied by the term "accuracy testing," but the specific method of establishing this ground truth (e.g., using a gold-standard imaging technique and detailed measurements) is not specified.

8. The Sample Size for the Training Set

The device is a physical navigation guide, not a machine learning algorithm that requires a "training set" in the computational sense. The planning software uses patient CT images, but these are for individual patient planning, not for training a generalized model. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The document states: "Cadaveric accuracy and sterilization stability testing of the FIREFLY Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY Pedicle Screw Navigation Guide performance is adequate to perform as intended."

This indicates that an experimental study was conducted using cadaveric specimens to evaluate the precision of the guide in directing surgical instruments and to confirm its sterility after processing. However, the details of these studies, including specific methodologies, data collected, statistical analyses, and the actual numerical results against defined acceptance criteria, are not provided in this 510(k) summary.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

Mighty Oak Medical, Incorporated Mr. Mark A. Wylie Director of Quality 750 West Hampden Avenue, Suite 120 Englewood, Colorado 80110

Re: K143222

Trade/Device Name: FIREFLY™ Pedicle Screw Navigation Guide Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI Dated: November 6, 2015 Received: November 9, 2015

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K143222

Device Name FIREFLYTM Pedicle Screw Navigation Guide

Indications for Use (Describe)

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

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Section 8 – 510(k) Summary

Date:	December 8, 2015
Sponsor:	Mighty Oak Medical, Inc.
	750 W. Hampden Ave., Suite 120
	Englewood, CO 80110
	(720) 398-9703
Contact Person:	Mark A. Wylie, Director of Quality
Trade Name:	FIREFLY ™ Pedicle Screw Navigation Guide
Common Name:	Pedicle Screw Placement Guide
Device Classification:	Class II
Regulation, Name:	888.3070, Pedicle screw spinal system
Device Product Code:	MNI
Device Description:	The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system 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.
Intended Use:	The FIREFLY Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY ™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.Use of the FIREFLY ™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of

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	anatomical landmarks. Only compatible OEM taps that are supplied with thepedicle screw spinal systems specified in the instructions for use may be usedthrough the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. Allother pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle ScrewNavigation Guide, as directed by the pedicle screw spinal system's instructionsfor use.
	This device is intended for single use only.
Materials:	The patient-contacting components of the FIREFLY™ Pedicle Screw NavigationGuide are manufactured from titanium alloy (ASTM F136), various stainlesssteels (ASTM F899), and epoxy resin (Accura ABS White SL 7810).
Predicate Devices:	Primary:MySpine Pedicle Screw Placement Guides (Medacta International SA: K132788)
	Reference:VSP® System (3D Systems [formerly Medical Modeling Inc.]: K120956 andK133907),TRUMATCH Personalized Solutions (DePuy Synthes: K110397)
Performance Data:	Cadaveric accuracy and sterilization stability testing of the FIREFLY Pedicle ScrewNavigation Guide was performed. The results demonstrated that the acceptancecriteria were met and that the FIREFLY Pedicle Screw Navigation Guideperformance is adequate to perform as intended.
TechnologicalCharacteristics:	The FIREFLY Pedicle Screw Navigation Guide possesses the same technologicalcharacteristics as the predicate devices. These include:
	• performance,
	• manufacturing process,
	• biocompatible materials, and
	• basic design.
	Technological characteristics which are different have been supported withdescriptive information and/or performance data. Therefore the fundamentalscientific technology of the System devices is the same as previously cleareddevices.
Conclusion:	The FIREFLY Pedicle Screw Navigation Guide possesses the same intended useand technological characteristics as the predicate devices. Therefore the FIREFLYPedicle Screw 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.