(24 days)
The SImmetry™ Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
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 use with the 6.5mm diameter screws.
The provided document is a 510(k) summary for the SImmetry™ Sacroiliac Joint Fusion System. This type of document is for a medical device that achieves substantial equivalence to a predicate device, rather than a novel AI/software as a medical device (SaMD) that would typically involve acceptance criteria and a study proving device performance in the way your request describes.
Therefore, the document does not contain the information needed to fulfill most of your request, such as acceptance criteria, specific study details with sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set information.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K110512) through:
- Identical intended use/indications for use.
- Identical design features, operational principles, and material composition.
- Mechanical performance testing to show the device provides necessary rigidity.
Here's a breakdown of what can be extracted and why other parts of your request cannot be answered from this specific document:
1. A table of acceptance criteria and the reported device performance
-
Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance, as this is a medical implant, not a diagnostic AI/SaMD.
-
Reported Device Performance: The document states, "Mechanical testing for axial pull out strength, driving torque, static bend strength and bending fatigue provided in this and previous 510(k)s demonstrate that the SImmetry Sacroiliac Joint Fusion System provides the necessary rigidity to support the intended use."
Performance Metric (Type of Test) Reported Outcome Axial pull out strength Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance). Driving torque Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance). Static bend strength Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance). Bending fatigue Demonstrated necessary rigidity to support intended use (compared to predicate, implicitly meeting its performance).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes mechanical testing of physical implants, not an AI/SaMD test set. There's no mention of human data, clinical performance, or a "test set" in the context of diagnostic accuracy.
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. There is no "ground truth" establishment by medical experts described, as this is a mechanical device, not an AI system being evaluated for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No adjudication method is necessary or mentioned for the mechanical testing described.
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. This is not an AI/SaMD and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. For the mechanical tests, the "ground truth" would be the engineering specifications and material properties, against which the device performance is measured. This is not a "ground truth" in the diagnostic sense.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/SaMD and therefore has no training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This is not an AI/SaMD and therefore has no training set or associated ground truth establishment.
{0}------------------------------------------------
JUL 2 1 2011
510(k) Summary
[As required by 21 CFR 807.92(c)]
1. Submitter / Contact Person / Date of Preparation
| Submitter | Zyga Technology, Inc.700 10th Ave South, Suite 20Minneapolis, MN 55415-1745 |
|---|---|
| Contact Person | Diane BrinzaDirector of Regulatory and Clinical AffairsPh. 612.455.1061, ext. 104Fax. 612.455.1064 |
| Date of Preparation | June 22, 2011 |
2. General Information
| Trade Name | SImmetry™ Sacroiliac Joint Fusion System |
|---|---|
| Common / UsualName | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Classification | Class II (per 21 CFR § 888.3040) |
| Manufacturer | Zyga Technology, Inc.700 10th Ave SouthMinneapolis, MN 55415-1745 |
| Identification ofPredicate Devices | K110512Zyga Technology, Inc.SImmetry™ Sacroiliac Joint Fusion System |
| Device Description | The SImmetry™ Sacroiliac Joint Fusion Systemconsists of cannulated screws available in titaniumhaving diameters ranging from 6.5mm-12.5mm; andlengths of 30mm-70mm; titanium washers areavailable for use with the 6.5mm diameter screws. |
| Intended Use /Indications for Use | The SImmetry™ Sacroiliac Joint Fusion System isintended for sacroiliac joint fusion for conditionsincluding sacroiliac joint disruptions and degenerativesacroiliitis. |
| TechnologicalCharacteristic | The principle of operation and fundamental scientifictechnology of the subject devices is identical to that ofthe identified predicate. |
| Materials | The subject devices are manufactured from TitaniumAlloy (Ti-6Al-4V ELI). |
| TechnologicalComparison | The principle of operation and fundamental scientifictechnology of the subject devices is identical to that ofthe identified predicate device. |
Page of 2
{1}------------------------------------------------
长川时时
.
| Summary ofNon-clinicalPerformance Data | Mechanical testing for axial pull out strength, drivingtorque, static bend strength and bending fatigueprovided in this and previous 510(k)s demonstratethat the SImmetry Sacroiliac Joint Fusion Systemprovides the necessary rigidity to support the intendeduse. |
|---|---|
| Conclusion | Equivalence for the SImmetry Sacroiliac Joint FusionSystem is based on the same intended use, designfeatures, operational principles, and materialcomposition and mechanical performance whencompared to the predicate device cleared underK110512. |
and the comments of the comments of the comments of
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zyga Technology, Incorporated % Ms. Diane Brinza Director of Regulatory Clinical and Quality Assurance 700 10th Avenue South, Suite 400 Minneapolis, Minnesota 55415
JUL 2 1 2011
Re: K111801
Trade/Device Name: SImmetryTM 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: June 22, 2011 Received: June 27, 2011
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Ms. Diane Brinza
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/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,
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
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 sacroillitis.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
for M. Melkerson
(Division/Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11180/
- lof/
§ 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.