The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and nonpedicle 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 confirmed by history and radiographic studies)
. spondy lolisthesis,
. trauma (i.e., fracture or dislocation),
. spinal stenosis,
. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
. tumor;
. pseudoarthrosis, and
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 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.

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. The expansion of indications for the Firebird Spinal Fixation System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediatric population.
A subset of the Firebird Spinal Fixation System and Phoenix MIS System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.5mm to 7.5mm and lengths ranging from 25mm to 60mm.

AI/ML Overview

The provided document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System. This type of regulatory submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a PMA.

Therefore, the document does not contain information about acceptance criteria and a study proving a device meets them in the way a diagnostic AI device or a novel therapeutic device would. Instead, it focuses on demonstrating equivalence to existing devices based on design, materials, indications for use, and mechanical performance.

I will attempt to extract the closest equivalents to your requested information where possible, based on the context of a 510(k) submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Device Performance

The Orthofix Firebird Spinal Fixation System is a Class III Preamendment Device (Pedicle screw spinal system) for which the manufacturer is seeking 510(k) clearance. A 510(k) clearance means the device is "substantially equivalent" to predicate devices. This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. It typically does not involve traditional clinical studies with acceptance criteria for device classification as one would expect for a novel device or an AI/diagnostic product.

Therefore, many of the requested points below are not directly applicable or quantifiable from this document.

A table of acceptance criteria and the reported device performance

Not applicable in the context of this 510(k) submission. The performance assessment is focused on "substantial equivalence" to predicate devices, primarily through mechanical testing and engineering analysis rather than specific clinical acceptance criteria.

The document states:
"Previous mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and finite element analysis."

While these tests have criteria for compliance with the standard, the document does not present a table of these criteria alongside specific device performance data. The conclusion drawn is that the device is substantially equivalent based on these results.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not explicitly stated for the mechanical testing mentioned. When mechanical testing is performed, the "sample size" refers to the number of physical devices or components tested. The data provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Mechanical testing does not involve "experts" establishing ground truth in the way a diagnostic study would. The standards for mechanical testing (e.g., ASTM F1717-04) define the methods and parameters.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Mechanical testing does not involve adjudication.
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. This is a spinal fixation system, not a diagnostic or AI-powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a spinal fixation system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set by engineering standards (e.g., ASTM F1717-04). For the expansion of indications (specifically for adolescent idiopathic scoliosis), the document mentions: "Published clinical results and engineering analysis supported expansion of indications." This implies that existing clinical literature for similar predicate devices, combined with engineering analysis (which would include the mechanical testing), served as the basis for justifying the expanded indications. Outcomes data or expert consensus from previously published studies might have indirectly informed this, but no new study for this submission is detailed.
The sample size for the training set

Not applicable. This is a spinal fixation system, not a machine learning model requiring a training set.
How the ground truth for the training set was established

Not applicable. This is a spinal fixation system, not a machine learning model.

Summary regarding the Firebird Spinal Fixation System and 510(k) process:

The K130932 submission for the Firebird Spinal Fixation System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This is achieved by showing that the device:

Has the same intended use.
Has the same basic technological characteristics (design, materials: titanium alloy per ASTM F136 and cobalt chrome per ASTM F1537, as with predicates).
Performs as safely and effectively as the predicate devices.

The "proof" the device meets acceptance criteria in this context relies on:

Mechanical Testing: Static and dynamic compression bending, and static torsion testing per ASTM F1717-04.
Finite Element Analysis (FEA).
Comparison to existing predicate devices: K081684, K082797, K100044, K093926, K122901 (Orthofix Inc.), K113666 (Stryker Spine), K091445 (Medtronic Sofamor Danek USA), K994121 (Synthes Spine), K121630 (K2M, Inc.), K111492 (Medtronic Sofamor Danek USA).

The document states: "Previous testing performed on this device indicates that the Firebird Spinal Fixation System is substantially equivalent to predicate devices." and "Published clinical results and engineering analysis supported expansion of indications." This means the mechanical performance met relevant engineering standards, and the safety and efficacy for the expanded indications (specifically pediatric adolescent idiopathic scoliosis) were supported by existing clinical literature and the device's engineering characteristics being similar to already approved predicate devices.

Summary

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K130932 Page 1 of 4

510(k) Summary

Submitter:	Orthofix, Inc.3451 Plano ParkwayLewisville, TX 75056
Contact:	Jacki GerenRegulatory Affairs SpecialistOrthofix, Inc.214.937.2100 (phone)214.937.3322 (fax)jackigeren@orthofix.com
	AUG 07 2013
Date Prepared:	April 2, 2013
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800 (phone)
Product Code(s):	NKB; OSH; KWP; MNH; MNI
Classification Name:	Pedicle screw spinal system
Device Class:	Class III Preamendment Device, 21 CFR §888.3070 - Pediclescrew spinal system - * Class III Summary and CertificationRequired
Classification Panel:	Orthopedic
Proprietary Name:	Firebird Spinal Fixation System
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 chromealloy, that allow the surgeon to build a spinal implant construct.The system is attached to the vertebral body and ilium by means ofscrew or hook fixation to the non-cervical spine. The FirebirdSpinal 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.The expansion of indications for the Firebird Spinal FixationSystem is proposed for the inclusion of adolescent idiopathicscoliosis alone, and not other indications for a pediatric population.

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A subset of the Firebird Spinal Fixation System and Phoenix MIS System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.5mm to 7.5mm and lengths ranging from 25mm to 60mm.

Indications For Use:

The Firebird Spinal Fixation System is intended for posterior, noncervical pedicle, and non-pedicle fixation (TI-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 confirmed by history and radiographic studies)
spondylolisthesis. .
trauma (i.e., fracture or dislocation), .
. spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or . lordosis).
tumor. ●
. pseudoarthrosis, and
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 SI or S2 spinal level.

The Phoenix MIS Spinal 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.

Titanium alloy per ASTM F136 and Cobalt-Chrome per ASTM F1537.

Materials:

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Predicate Devices:

The Firebird Spinal Fixation System is substantially equivalent to the predicate devices:

K081684, K082797, K100044, K093926 and K122901-Firebird Spinal Fixation System manufactured by Orthofix Inc.

K113666-XIA III Spinal System manufactured by Stryker Spine

K091445-CD HORIZON Spinal System manufactured by Medtronic Sofamor Danek USA

K994121-USS Small Stature manufactured by Synthes Spine

K121630- Range Spinal System manufactured by K2M, Inc.

K111492-TSRH Spinal System manufactured by Medtronic Sofamor Danek USA

The design features, material and indications for use of the Firebird Spinal Fixation System are substantially equivalent to the XIA III (K113666), CD Horizon Spinal System (K091445), USS Small Stature (K994121), Range Spinal System (K121630), and the TSRH Spinal System (K111492). The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design.

Performance Data: Previous testing performed on this device indicates that the Firebird Spinal Fixation System is substantially equivalent to predicate devices. Previous mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and finite element analysis. Published clinical results and engineering analysis supported expansion of indications.

The Firebird Spinal Fixation System is shown to be substantially Conclusion: equivalent to previously cleared devices with respect to intended use, design, function, materials, and performance.

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The Firebird Spinal Fixation System has the same technological characteristics, materials and intended use as the predicate devices.

The subject Firebird Spinal Fixation System and the Design: predicate devices are designed for posterior fixation from T1 to S2/Ilium using a posterior approach.

Materials: The subject Firebird Spinal Fixation System and the predicate devices are all manufactured with titanium alloy (Ti6al4V ELI per ASTM F136) or cobalt chrome (per ASTM F1537)

The subject Firebird Spinal Fixation System and the predicate devices (all system rods) are manufactured with the option of titanium alloy (Ti6al4V ELI per ASTM F136) or Cobalt Chrome (per ASTM F1537).

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

August 7, 2013

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

Re: K130932

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, MNH, MNI, KWP Dated: July 03, 2013 Received: July 08, 2013

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 not : 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 cither 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 that + Dr. has Intatutes 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 (reporting of medical device-related adverse cvents) (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources.forYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours.

Erin I. Keith

For

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

Enclosure

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5. Indications for Use

510(k) Number (if known): K130932

Device Name: Firebird Spinal Fixation System

. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
. spondy lolisthesis,
. trauma (i.e., fracture or dislocation),
. spinal stenosis,
. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
. tumor;
. pseudoarthrosis, and
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 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130932

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.