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, ●
degenerative sacroiliitis, ●
to augment immobilization and stabilization of the sacroiliac ioint in skeletally mature . patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint. ●

Device Description

The FIREBIRD SI Fusion System is a temporary multiple component system consisting of nonsterile 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-6Al-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.

The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

AI/ML Overview

The provided text is a 510(k) summary for the FIREBIRD SI Fusion System. It states that there are no changes to the technological characteristics, intended use, or overall risks associated with the device compared to its predicate device. Therefore, no new design verification or validation testing was required for this particular submission. The summary explicitly states that the previous testing performed for earlier 510(k) clearances (K201664, K200696, and K183342) is applicable.

This means the document does not contain the information requested regarding acceptance criteria and study details for the current K203138 submission because new studies were not conducted. It refers to previous clearances.

To answer your request, I would need access to the 510(k) summaries or supporting documentation for the predicate devices mentioned, specifically:

K201664 - Orthofix Inc. - FIREBIRD SI Fusion System (Primary Predicate)
K200696 (Mentioned as having applicable testing)
K183342 (Mentioned as having applicable testing)

Without access to those specific documents, I cannot provide the detailed acceptance criteria and study information you've requested.

However, based on the provided text, I can state the following:

1. A table of acceptance criteria and the reported device performance

Not provided in this document. The document states "no new design verification or validation testing was required" for this submission (K203138). It refers to previous 510(k)s for relevant data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in this document.

3. 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/Not provided in this document. This device is a bone fixation system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the way you're describing. Its testing would involve mechanical and biocompatibility assessments, not clinical interpretation.

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

Not applicable/Not provided in this document.

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/Not provided in this document. This device is a physical implant, not an AI diagnostic tool.

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

Not applicable/Not provided in this document.

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

Not applicable/Not provided in this document for the reasons stated above (physical implant, not an AI/diagnostic device). "Ground truth" for this type of device would typically relate to mechanical properties (e.g., strength, fatigue life) matching specific standards or predicate performance, and biocompatibility.

8. The sample size for the training set

Not applicable/Not provided in this document. No AI training set is relevant for this physical device.

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

Not applicable/Not provided in this document.

In summary: The provided document is a 510(k) summary for a physical medical device (bone fixation system). It leverages previous clearances for its substantial equivalence argument, stating that no new testing was required for this specific submission (K203138) because the device's technological characteristics, intended use, and risks are unchanged from its predicates. The questions you've posed (especially those about AI, readers, ground truth establishment, training sets) are highly relevant for AI/Software as a Medical Device (SaMD), but generally are not directly applicable to the type of device described in this 510(k) (a physical implantable screw system).

Summary

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November 18, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K203138

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: October 19, 2020 Received: October 20, 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 mediation-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, M.B.E. Assistant Director 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K203138

Device Name FIREBIRD SI Fusion System

Indications for Use (Describe)

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,

· degenerative sacroiliitis,

· to augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

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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510(k) SUMMARY

FIREBIRD SI Fusion System

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:	October 19, 2020
Name of DeviceTrade Name / Proprietary Name:	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:	K201664 - Orthofix Inc. - FIREBIRD SI Fusion System
Reference Device:	K193524 - SI-Bone, Inc. – SI-BONE iFuse Implant System

Device Description

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

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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, ●
degenerative sacroiliitis, ●
to augment immobilization and stabilization of the sacroiliac ioint in skeletally mature . patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint. ●

Summary of Substantial Equivalence

There are no changes to the technological characteristics of the device that are the subject of this 510(k). The FIREBIRD SI Fusion System implants are technologically identical to and has the same intended use and substantially similar indications for use as the previously cleared predicate devices (K201664; as well as the reference predicate cleared in K193524). The proposed indications for use statement does not introduce any new indications, does not alter the therapeutic effect or use of the implants and does not expand use of the implants beyond uses contemplated under the cleared predicate (510(k)s. In conclusion, the FIREBIRD SI Fusion System with clarified indication for use statement is substantially equivalent to the predicate devices.

Summary of Verification and Validation Activities

There were no changes in the design, technological features, intended use or overall risks associated with the FIREBIRD SI Fusion System. Therefore, no new design verification or validation testing was required; the design verification and validation testing previously conducted and submitted in previously cleared FIREBIRD SI Fusion System 510(k)s is applicable (K201664, K200696 and K183342).

Orthofix follows established quality system and design control requirements in accordance with the Quality System Regulation (21 CFR 820) and declares conformance to design controls and risk-based assessment procedures, including Hazards Analysis and FMEA assessments.

Conclusion

The intended use and the technological characteristics are unchanged compared to the predicate device; therefore, the subject device is substantially equivalent to the predicate device.

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.