The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.

AI/ML Overview

The provided FDA 510(k) clearance letter for the "panaSIa SI Fusion System" describes a medical device, specifically a smooth or threaded metallic bone fixation fastener, intended for sacroiliac (SI) joint fusion.

Based on the provided document, the acceptance criteria and the study proving the device meets these criteria are limited in detail. This is typical for a 510(k) clearance for this type of device, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than extensive clinical studies or AI algorithm performance validation.

Here's an analysis of the provided information, addressing your points where possible, and noting where information is not present in the document.

Overview of Device and Clearance Type

The panaSIa SI Fusion System is a physical implant (a threaded, expandable device made of titanium grade alloy) used for sacroiliac joint fusion. The FDA clearance is a 510(k), which means the manufacturer demonstrated the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on non-clinical testing (e.g., mechanical performance) and comparison of design, materials, and indications for use, rather than extensive human clinical trials or complex AI performance metrics.

Acceptance Criteria and Study Details (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission (510(k) for a physical implant), the "acceptance criteria" are not explicitly quantifiable metrics like sensitivity/specificity for an AI algorithm. Instead, they are typically the successful fulfillment of recognized standards and comparative performance to predicates.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Document)	Reported Device Performance (From Document)
Intended Use Equivalence	Same intended use as predicate devices.	"The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." - Matches indications for predicate devices.
Principles of Operation Equivalence	Similar principles of operation as predicate devices.	"The subject device and the predicate devices have similar principles of operation..."
Design Equivalence	Similar design as predicate devices.	"...designs..."
Material Equivalence	Similar materials as predicate devices.	"...and use similar materials. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy."
Performance (Mechanical) Equivalence	Meets or exceeds mechanical testing standards (ASTM F3574) and performs comparably to predicate in relevant tests (e.g., cadaver testing).	"The non-clinical testing data submitted and relied upon to demonstrate substantial equivalence included static and dynamic vertical shear testing per ASTM F3574 and cadaver testing with comparison to the additional predicate device."
Safety & Effectiveness	Demonstrates comparable safety and effectiveness to predicate devices.	"The panaSIa SI Fusion System is as safe, as effective, and performs as well as, or better, than the predicate devices."

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

Sample Size: The document mentions "cadaver testing," which refers to ex vivo testing of the device. However, it does not specify the sample size (i.e., number of cadavers or test specimens from cadavers) used for this testing.
Data Provenance: The document does not specify the country of origin of the cadaver data or whether the testing was retrospective or prospective. Given it's cadaver testing, it's inherently a controlled, ex vivo experimental setup rather than a patient-based retrospective/prospective study.

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

This information is not applicable/not provided in this type of 510(k) submission. The "ground truth" for a physical implant's mechanical performance is typically established by engineering standards (like ASTM F3574) and direct measurement, not by expert consensus on image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies or clinical trials where human interpretation or consensus is required. This information is not applicable/not provided for a mechanical device performance test.

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

This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). This device is a physical implant; therefore, no MRMC study was done or is relevant for this submission.

6. Standalone (Algorithm Only) Performance Study

This refers to the performance of an AI algorithm alone, without human intervention. Since this is a physical medical device and not an AI algorithm, a standalone algorithm performance study was not conducted or is not relevant.

7. Type of Ground Truth Used

For the non-clinical performance testing:
- Mechanical Standards: Adherence to established engineering standards (ASTM F3574 for static and dynamic vertical shear testing).
- Comparative Performance: The performance of the device was directly compared against a predicate device in cadaver models. While not explicitly stated as "ground truth," the predicate device's known performance serves as the benchmark against which the new device is measured.
- No clinical outcomes or pathology ground truth was used for this 510(k) clearance, as it is based on substantial equivalence through non-clinical testing.

8. Sample Size for the Training Set

This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through a formalized data training set as seen in AI development.

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

As there is no AI "training set," this question is not applicable.

In summary, the provided FDA 510(k) clearance letter details a non-AI medical device (an SI joint fusion implant). The "acceptance criteria" and "study" proving these criteria are primarily based on:

Substantial equivalence to legally marketed predicate devices in terms of intended use, principles of operation, design, and materials.
Non-clinical performance testing, specifically:
- Adherence to ASTM F3574 for static and dynamic vertical shear testing.
- Comparative cadaver testing against an additional predicate device.

The document does not delve into the detailed quantitative results of these tests (e.g., exact maximum shear force sustained), sample sizes of cadavers, or the specific methods of ground truth establishment beyond relying on industry standards and direct comparison. This level of detail for non-clinical testing is typically found within the full 510(k) submission, not the public-facing clearance letter.

Summary

FDA 510(k) Clearance Letter - panaSIa SI Fusion System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 9, 2025

Wenzel Spine, Inc.
℅ Justin Eggleton
Vice President, Head of Musculoskeletal Regulatory Affairs
MCRA, LLC
803 7th Street NW, Third Floor
Washington, District of Columbia 20001

Re: K250247
Trade/Device Name: panaSIa 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: January 27, 2025
Received: June 16, 2025

Dear Justin Eggleton:

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 (the 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 available 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.

July 9, 2025

Wenzel Spine, Inc.
℅ Justin Eggleton
Vice President, Head of Musculoskeletal Regulatory Affairs
MCRA, LLC
803 7th Street NW, Third Floor
Washington, District of Columbia 20001

Dear Justin Eggleton:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250247 - Justin Eggleton Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250247 - Justin Eggleton Page 3

assistance/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,

MAZIAR SHAHMOHAMMADI -S

For: Brent Showalter, Ph.D.
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

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250247

Device Name
panaSIa SI Fusion System

Indications for Use (Describe)
The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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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Page 5

510(k) Summary

Device Trade Name: panaSIa SI Fusion System

Manufacturer: Wenzel Spine, Inc.
2535 Brockton Drive, Suite 450
Austin, TX 78758

Contact: Justin Eggleton
Vice President, Head of Musculoskeletal Regulatory Affairs
MCRA, LLC
803 7th Street, NW
Washington, DC 20001
jeggleton@mcra.com

Prepared by: MCRA, LLC
803 7th Street, NW, 3rd Floor
Washington, DC 20001
Office: 202.552.5800

Date Prepared: July 8, 2025

Classifications: 21 CFR §888.3040

Class: II

Product Code: OUR

Primary Predicate: Camber Spine Technologies Camber Sacroiliac (SI) Fixation System (K233972)

Additional Predicate: Medtronic Sofamor RIALTO™ SI Fusion System (K161210)

Indications For Use:
The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description:
The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.

K250247- Page 1 of 2

Page 6

Performance Testing Summary:
To support the clearance of the subject device, Wenzel Spine completed non-clinical testing. The non-clinical testing data submitted and relied upon to demonstrate substantial equivalence included static and dynamic vertical shear testing per ASTM F3574 and cadaver testing with comparison to the additional predicate device.

Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate devices with respect to intended use, principles of operation, indications for use, design, materials, and performance.

The subject device and the predicate devices are intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The subject device and the predicate devices have similar principles of operation, designs, performance, and use similar materials.

Conclusion:
The subject device and the predicate devices have the same intended use, have similar technological characteristics, principles of operation, performance, and are made of similar materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The panaSIa SI Fusion System is as safe, as effective, and performs as well as, or better, than the predicate devices.

K250247- Page 2 of 2

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.