The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac ioint disruptions and degenerative sacroiliitis.

Device Description

The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws.

AI/ML Overview

This document describes the regulatory submission for the SImmetry Sacroiliac Joint Fusion System, a medical device, and therefore does not contain information related to software or AI system performance, ground truth, or study designs typically associated with such. The document focuses on showing substantial equivalence to a predicate device through non-clinical bench testing.

Here's an analysis of the provided text based on the requested information regarding acceptance criteria and a study proving those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Bending Fatigue	"Results demonstrate that the implants perform as well or better than the predicate devices."
Torsion	"Results demonstrate that the implants perform as well or better than the predicate devices."

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

The document does not specify a "test set" in the context of clinical data, as this is a 510(k) submission for a modification to a previously cleared device, focusing on non-clinical bench testing.

Sample Size: Not explicitly stated for bench tests (e.g., number of screws tested). It refers to "the worst case SImmetry implant" which suggests a limited number of samples were used for testing the specific modification.
Data Provenance: The data is from "Non-Clinical bench tests" performed by Zyga Technology, Inc. There is no information regarding country of origin or whether it's retrospective or prospective, as these terms are not applicable to bench testing.

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

This information is not applicable. The "ground truth" here is established by standardized mechanical testing protocols (ASTM F1264 for bending fatigue and ASTM F543 for torsion). No human experts or clinical ground truth are involved in evaluating the performance of the device against these mechanical standards.

4. Adjudication Method for the Test Set

This is not applicable. The "test set" refers to mechanical bench testing, where outcomes are quantitative measurements based on engineering standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for evaluating human performance, often in conjunction with AI, typically in diagnostic imaging. The submission is for a medical implant and relies on non-clinical bench testing, not clinical studies involving human readers. Therefore, no effect size for human readers improving with or without AI assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This document describes a physical medical implant, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by standardized mechanical test methods (ASTM F1264 for bending fatigue and ASTM F543 for torsion) and comparison against a legally marketed predicate device. The goal is to demonstrate that the modified device performs "as well or better" than the predicate under these objective engineering tests.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

This information is not applicable, as there is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of non-clinical bench tests.

Study Design: Mechanical testing was performed on "the worst case SImmetry implant" using established ASTM standards.
Tests Conducted:
- Bending fatigue per ASTM F1264
- Torsion per ASTM F543
Objective: To demonstrate that the modified SImmetry Sacroiliac Joint Fusion System performs as well as or better than its predicate device (K111801).
Conclusion: The tests demonstrated that the implants perform "as well or better than the predicate devices," leading to the conclusion of substantial equivalence based on mechanical performance.

This type of submission focuses on demonstrating the safety and effectiveness of a device modification through engineering principles and comparative mechanical performance, rather than clinical efficacy, for which a different type of study would be required.

Summary

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K130092

510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

1. Submitter / Contact Person / Date of Preparation

Submitter	Zyga Technology, Inc.700 10th Ave SouthMinneapolis, MN 55415-1745
Contact Person	Diane BrinzaDirector of Regulatory AffairsPh. 612.455.1061, ext. 104Fax. 612.455.1064
Date of Preparation	January 11, 2013

2. General Information

Trade Name	SImmetry® Sacroiliac Joint Fusion System
Common / UsualName	Fixation Device/Bone Screw
Classification	Smooth or threaded metallic bone fixation fastenerProduct Code, OUR21 CFR § 888.3040Class II
Manufacturer	Zyga Technology, Inc.700 10th Ave South Suite 20Minneapolis, MN 55415-1745
Identification ofPredicate Devices	K111801Zyga Technology, Inc.SImmetry Sacroiliac Joint Fusion System
Reason for PremarketNotification	This premarket notification addresses the addition of a newwasher component and geometrical modifications to thedevice including modification of the surface finish, threadprofile, and drive features for the implant.

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Device Description	The SImmetry Sacroiliac Joint Fusion System consists ofcannulated screws available in titanium having diametersranging from 6.5mm-12.5mm; and lengths of 30mm-70mm;titanium washers are available for the 6.5mm diameterscrews.
Intended Use /Indications for Use	The SImmetry® Sacroiliac Joint Fusion System is intendedfor sacroiliac joint fusion for conditions including sacroiliacioint disruptions and degenerative sacroiliitis.
TechnologicalCharacteristic	The principle of operation and fundamental scientifictechnology of the subject devices is identical to that of theidentified predicate.
Materials	The subject devices are manufactured from Titanium Alloy(Ti-6Al-4V ELI).
TechnologicalComparison .	The modification of the SImmetry Sacroiliac Joint FusionSystem does not represent a change in technologicalcharacteristics from that of the indicated predicate device.and therefore does not raise any new questions of safety oreffectiveness.
Summary ofNon-clinicalPerformance Data	Non-Clinical bench tests were performed using the worstcase SImmetry implant in bending fatigue per ASTM F1264and in torsion per ASTM F543. Results demonstrate that theimplants perform as well or better than the predicatedevices.
Conclusion	Equivalence for the SImmetry Sacroiliac Joint FusionSystem is based on the same indications for use, designfeatures, operational principles, and material compositionand mechanical performance when compared to thepredicate device cleared under K111801.

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

February 27, 2013

Zyga Technology, Incorporated % Ms. Diane Brinza Director of Regulatory, Clinical and Quality Assurance 700 10th Avenue South, Suite 20 Minneapolis, Minnesota 55415-1745

Re: K130092

Trade/Device Name: SImmetry Sacroiliac Joint 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: February 1, 2013 Received: February 4, 2013

Dear Ms. Brinza:

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 (reporting of medical

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Page 2 - Ms. Diane Brinza

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ErinI.D.Keith

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

Enclosure

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Attachment A
	Indications for Use Statement

510(k) Number (if known)	K130092
Device Name	SImmetry Sacroiliac Joint Fusion System
Indications for Use	The SImmetry ® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Prescription Use (Per 21 CFR 801.109)	√

	OR	Over-The-Counter Use (21 CFR 801 Subpart C)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth 詞詞ank -S

Division of Orthopedic Devices

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.