The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation (T1 - S2/ Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: a) Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); b) Spondylolisthesis: c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumors: g) Pseudoarthrosis, and h) Failed previous fusion When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors. When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Firebird Spinal Fixation System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical or performance study in the way an AI/ML device would.

Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, AI performance metrics) is not applicable to this document as it pertains to a mechanical spinal fixation system, not a software or AI/ML device.

However, I can extract the relevant information regarding performance data as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (spinal fixation system), "acceptance criteria" are typically defined by the standard mechanical tests and their pass/fail requirements, demonstrating that the modified device's performance is equivalent to the predicate device.

Test Characteristic	Standard / Test / FDA Guidance	Reported Device Performance (Summary)
Static Torsion Test	N/A (No change from predicate device)	This test was not performed on the subject device because there were no changes that would affect its static torsional properties. The device is considered substantially equivalent to the predicate device in this regard.
Static Axial Compression Bending Test	N/A (No change from predicate device)	This test was not performed on the subject device because there were no changes that would affect its static axial compression bending properties. The device is considered substantially equivalent to the predicate device in this regard.
Dynamic Axial Compression Bending Test	ASTM F1717-14	Subject lined rods demonstrated substantial equivalence to the predicate device with respect to fatigue properties.
Axial Rod Gripping Test	ASTM F1798-13	Subject lined rods demonstrated substantial equivalence to the predicate device with respect to static axial rod gripping properties.

Explanation of "Acceptance Criteria" for this device: The primary "acceptance criterion" for this 510(k) submission is that mechanical testing demonstrates that the modified device (Firebird Spinal Fixation System with lined rods) is substantially equivalent to the predicate device (Firebird Spinal Fixation System K130932) and the other predicate (LDR Spine USA SpineTune TL System K120760) per the specified ASTM standards. The specific quantitative results (e.g., load-to-failure values, cycles to failure) are not provided in this summary, but the conclusion that equivalence was demonstrated indicates the acceptance criteria were met.

2. Sample size used for the test set and the data provenance:

Sample size: The document does not specify the number of samples used for each mechanical test.
Data provenance: The data provenance is from the mechanical testing performed on the device components themselves, adhering to specific ASTM standards in a laboratory setting. This is not clinical data (retrospective or prospective from a country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a mechanical device, and "ground truth" (in the context of expert consensus or pathology) is not established by human experts for mechanical performance testing. Ground truth for mechanical tests is the quantitative measurement of physical properties against engineering specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in studies involving interpretation of medical images or clinical outcomes. Mechanical testing does not involve this type of adjudication.

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:

Not Applicable. An MRMC study is relevant for diagnostic imaging devices involving human readers and AI. This document describes a spinal fixation system, which is a physical implant, not a diagnostic AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This refers to the performance of an AI algorithm without human involvement. This document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For mechanical performance testing, the "ground truth" is defined by the measured physical properties and performance characteristics (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1717-14, ASTM F1798-13) against the established performance of predicate devices.

8. The sample size for the training set:

Not Applicable. This is a mechanical device, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established:

Not Applicable. As above, no training set is involved for this type of device submission.

Summary

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

January 2, 2015

Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K141186

Trade/Device Name: Firebird Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP Dated: October 31, 2014 Received: November 6, 2014

Dear Ms. Geren:

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

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Page 2 - Ms. Jacki Geren

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/Resourcesfor You/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 vours.

Lori A. Wiggins -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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Indications for Use

510(k) Number (if known) K141186

Device Name Firebird Spinal Fixation System

Indications for Use (Describe)

a) Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);

b) Spondylolisthesis:

c) Trauma (i.e., fracture or dislocation);
d) Spinal stenosis;

e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);

f) Tumors:

g) Pseudoarthrosis, and

h) Failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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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Image /page/3/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol next to it. The abstract shape is made up of curved lines that form a circular shape with a gap in the middle.

510(k) Summary

Name:	Orthofix Inc.
Address:	3451 Plano ParkwayLewisville, Texas 75056
Telephone Number:	214-937-2000
Fax Number:	214-937-3322
Email:	jackigeren@orthofix.com
Registration Number:	3008524126
Contact Person:	Jacki GerenRegulatory Affairs Specialist
Date Prepared:	May 6, 2014
Name of Device
Trade Name/ProprietaryName:	Firebird Spinal Fixation System
Common Name:	Spinal Fixation System
Product Code:	NKB; OSH; KWP; MNH; MNI
Regulatory Classification:	21 CFR §888.3070Pedicle screw spinal system (Class III)
Review Panel:	Orthopedic Device Panel
Predicate Devices:	Orthofix Firebird Spinal Fixation System - K130932 (primary predicate)LDR Spine USA SpineTune TL System - K120760 (additional predicate)No reference devices were used in this submission
Reason for 510(k) Submission:	Modification to all straight titanium alloy (Ti-6AL-4V ELI) rods to placea line longitudinally along the length of the rod to provide betteridentification of induced curvature.
Device Description:	The Firebird Spinal Fixation System is a temporary, titanium alloy,multiple component system comprised of a variety of non-sterile, singleuse components, made of titanium alloy or cobalt chrome alloy, thatallow the surgeon to build a spinal implant construct. The system isattached to the vertebral body and ilium by means of screw or hookfixation to the non-cervical spine. The Firebird Spinal Fixation Systemconsists of an assortment of rods, multi-axial and mono-axial pediclescrews, set screws, lateral offsets, bone screws, screw bodies, hooks andiliac connectors.

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Image /page/4/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, bold letters. The shape is a curved, three-dimensional design, and the word "ORTHOFIX" is in a sans-serif font, with a registered trademark symbol next to the "X".

Intended Use / Indications for Use:

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non pedicle fixation (T1 - S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc a) confirmed by history and radiographic studies);
Spondylolisthesis: b)
Trauma (i.e., fracture or dislocation); C)
Spinal stenosis: d)
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); e)
f) Tumors;
Pseudoarthrosis, and g)
Failed previous fusion h)

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors,

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Characteristics	Firebird Spinal FixationSystem(Subject Device)	Predicate Device:Firebird Spinal FixationSystem(K130932)	Predicate Device:LDR Spine USASpineTune TL System(K120760)
Device Name	Firebird Spinal FixationSystem	Firebird Spinal FixationSystem (K130932)	SpineTune TL System(K120760)
Method ofFixation	Non-Cervical Fixation	Non-Cervical Fixation	Non-Cervical Fixation
Implantation	Posterior Approach	Posterior Approach	Posterior Approach
Design	This system allows asurgeon to build a spinalimplant construct	This system allows asurgeon to build a spinalimplant construct	This system allows asurgeon to build a spinalimplant construct
Material	Titanium alloy (Ti-6AL-4V ELI)	Titanium Alloy (Ti-6AL-4V ELI)	Titanium alloy
LongitudinalLine on Rods	Yes	No	Yes

Summary of Technological Characteristics of the Device Compared to the Selected Predicate Device

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Image /page/5/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol next to the word. The abstract shape is a curved, three-dimensional shape that resembles a stylized "O".

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Characteristics	Standard / Test / FDA Guidance
Static Torsion Test	N/A No change from the predicate device
Static Axial Compression Bending Test	N/A No change from the predicate device
Dynamic Axial Compression Bending Test	ASTM F1717-14
Axial Rod Gripping Test	ASTM F1798-13

Performance Data Summary

Mechanical testing for the subject Firebird Spinal Fixation System lined rods were conducted in accordance with ASTM F1717-14 Standard Test Method for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model and ASTM 1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Test results demonstrated that the subject lined rods are substantially equivalent to the predicate device Firebird Spinal Fixation System (K130932) which has the same intended use, similar indications, technological characteristics, and principles of operations

Basis of Substantial Equivalence

The subject Firebird Spinal Fixation System straight titanium alloy (Ti-6AL-4V ELI) lined rods are substantially equivalent to the predicate devices based on indications for use, intended use, design, materials and function and mechanical performance.

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.