The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6AI-4V ELI) with lengths ranging from 25mm to 70mm.

The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.

The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.

AI/ML Overview

The provided text is a 510(k) summary for the Orthofix FIREBIRD SI Fusion System. It describes the device, its intended use, and a summary of non-clinical performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the document in relation to your request about acceptance criteria and the study proving the device meets them:

Key Finding:

The document describes non-clinical mechanical testing to demonstrate substantial equivalence for a bone screw, not a medical imaging or AI-enabled device requiring clinical performance studies with human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (sensitivity, specificity, human reader improvement, etc.) is not applicable to this specific submission.

The "acceptance criteria" here relate to engineering specifications and mechanical performance of a medical implant, as assessed by ASTM standards.

Let's break down what information is available and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of mechanical tests performed and the standards they were conducted under. It does not provide specific numerical acceptance criteria (e.g., "must withstand X N of force") or the exact numerical results for each test (e.g., "device withstood Y N of force"). It refers to Appendices (e.g., Appendix B: Static Cantilever Beam Testing 10117508AA) where these results would presumably be detailed. Without access to these appendices, specific performance numbers cannot be reported in a table.

However, based on the type of device and the nature of the 510(k) submission, the "acceptance criteria" are implicitly that the new 9mm FIREBIRD SI Screws perform comparably or better than the predicate/reference devices in the mechanical tests, thereby demonstrating substantial equivalence.

Inferred Acceptance Criteria (Based on context of a 510(k) for a mechanical implant):

Device mechanical properties (strength, fatigue life etc.) meet or exceed those specified in the relevant ASTM standards for the intended use.
Device mechanical properties are substantially equivalent to the predicate device (SambaScrew 3D SI Fusion System) and reference device (SAMBA Screw System).

Reported Device Performance (Qualitative, as specific numbers are not provided in the summary):

The mechanical tests (Static and Dynamic cantilever beam, Static Torsion, Static Axial Pull-Off) were conducted in accordance with ASTM F2193 and ASTM F543.
The conclusion states: "The performance and technological characteristics of the subject device are similar to the reference device (K121148) in terms of design, materials and performance characteristics." and "There are no significant differences between the subject device, predicate device and reference device, which would adversely affect the use of the product."

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

Sample Size: Not explicitly stated in the summary for the mechanical tests. For mechanical testing of medical devices, sample sizes are typically small (e.g., n=5 or n=10 per test) as determined by the specific ASTM standard.
Data Provenance: The tests were "conducted" as part of the submission, presumably by the manufacturer or a third-party testing lab. The location/country of origin of the data is not specified, but the submission is to the US FDA. The nature of the study is non-clinical engineering testing, not clinical data, so the retrospective/prospective distinction is not applicable in the typical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

N/A. This information is relevant for clinical studies, especially those involving AI for diagnostic interpretation. For a bone screw's mechanical performance, "ground truth" is established by the physical testing and measurement against engineering standards. There are no clinical "experts" establishing a diagnostic ground truth here.

4. Adjudication Method for the Test Set

N/A. Adjudication is relevant for ambiguous clinical cases in diagnostic studies. For mechanical testing, the results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a mechanical implant, not an imaging device or AI-assisted diagnostic tool. MRMC studies are used to assess the impact of a new diagnostic method (often AI) on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

N/A. This device does not involve an algorithm or AI.

7. Type of Ground Truth Used

Engineering Standards and Measurements: The "ground truth" for this device's performance is derived from the physical properties and mechanical behavior of the screws as measured in laboratory tests, compared against the requirements of ASTM standards and the performance of predicate devices.

8. Sample Size for the Training Set

N/A. There is no "training set" as this is not an AI/machine learning product.

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

N/A. As above, no training set.

In summary, the provided document describes a 510(k) submission for a mechanical medical implant (bone screw) that relies on non-clinical performance data (mechanical testing) to demonstrate substantial equivalence. It does not involve clinical performance data, AI algorithms, or diagnostic capabilities that would necessitate the types of "acceptance criteria" and "study proofs" typically requested for AI/imaging devices (e.g., sensitivity, specificity, human reader studies, expert adjudication).

Summary

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April 2, 2020

Orthofix Inc. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K200696

Trade/Device Name: FIREBIRD SI Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: March 16, 2020 Received: March 17, 2020

Dear Ms. Koch:

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

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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/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, MBE Assistant Director (Acting) 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) K200696

Device Name FIREBIRD SI Fusion System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A small registration mark is visible to the upper right of the word "ORTHOFIX".

FIREBIRD SI Fusion System

510(k) SUMMARY

FIREBIRD SI Fusion System (Formally SambaScrew 3D SI Fusion System)

510(k) Owner Information
Name:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214-937-2100214-937-3322jackikoch@orthofix.com
Registration Number:	2183449
Contact Person:	Jacki Koch, Senior Regulatory Affairs Specialist
Date Prepared:	March 16, 2020
Name of DeviceTrade Name / ProprietaryName:	FIREBIRD SI Fusion System
Common Name:	Sacroiliac Joint Fixation Bone Screw
Product Code:	OUR
Regulatory Classification:	Class II – 21 CFR § 888.3040
Review Panel:	Orthopedic Device Panel
Primary Predicate:	K183342 - SambaScrew 3D SI Fusion System
Reference Device:	K121148 - SAMBA Screw System

Reason for 510(k) Submission: Due to advancements in surgeon requests, Orthofix is submitting this Special 510(k) premarket notification for the addition of the following device below to the previously cleared SambaScrew 3D SI Fusion System (K183342) now branded as the FIREBIRD SI Fusion System:

. Addition of new 9mm FIREBIRD SI Screws

Device Description

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K200696 - Page 2 of 3

Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the upper right of the "X" in "ORTHOFIX".

FIREBIRD SI Fusion System

The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.

Intended Use / Indications for Use

The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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

The technological characteristics of the FIREBIRD SI Fusion System are similar to the predicate (K183342 SambaScrew 3D SI Fusion System) in terms of intended use, indication for use and patient population. The subject 9mm FIREBIRD SI Screws are similar to the reference device (K121148 SAMBA Screw System) in terms of design and performance characteristics.

The technical characteristics of the subject device present no significant differences between the predicate and reference devices which would adversely affect the use of the product.

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

Mechanical testing consisting of Static and Dynamic cantilever beam Test. Static Torsion Test and Static Axial Pull-Off Test were conducted in accordance to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and in accordance to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.

SubjectDevice	Mechanical Testing	Appendix
	Static cantilever beam test perASTM F2193-18a StandardSpecifications and Test Methodsfor Components Used in theSurgical Fixation of the SpinalSkeletal System	Appendix B: Static Cantilever Beam Testing10117508AA
9mmFIREBIRDSI Screws	Dynamic cantilever beam test perASTM F2193-18a StandardSpecifications and Test Methodsfor Components Used in theSurgical Fixation of the SpinalSkeletal System	Appendix C: Dynamic Cantilever BeamTesting 10117509AA
	Static torsion test per ASTM F543-17 Standard Specification andTest Methods for Metallic MedicalBone Screws	Appendix D: Static Torsion Testing10117507AA

Table 1: Mechanical Performance Testing

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FIREBIRD SI Fusion System

	Static axial pullout test per ASTMF543-17 Standard Specificationand Test Methods for MetallicMedical Bone Screws	Appendix E: Static Axial Pullout Testing10117506AA
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Conclusions

The addition of the 9mm FIREBIRD SI Screws to the previously cleared FIREBIRD SI Fusion System (formally known as SambaScrew 3D SI Fusion System) does not change the previously cleared (K183342) indications for use, intended use, contraindications, warnings or precautions. Furthermore, the surgical approach and implantation technique remains the same as previously cleared (K183342).

The performance and technological characteristics of the subject device are similar to the reference device (K121148) in terms of design, materials and performance characteristics.

There are no significant differences between the subject device, predicate device and reference device, which would adversely affect the use of the product.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.