The Mixing Syringe System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Device Description

The Mixing Syringe System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger), and mixing system funnel. The Mixing Syringe System is provided sterile, for single use only.

AI/ML Overview

The provided text describes the "Mixing Syringe System," a medical device, and the basis for its 510(k) clearance. However, it does not detail a study involving AI, human readers, or the establishment of ground truth for such a study. The information focuses on the device's functional performance and substantial equivalence to predicate devices, not on a diagnostic or interpretive AI algorithm.

Therefore, many of the requested elements (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered based on the provided text, as they pertain to studies involving AI algorithm performance and clinical interpretation that were not performed or reported here.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance
Simulated Use Testing	Met all specified criteria
Volume Verification	Met all specified criteria
Separation Force Testing	Met all specified criteria
Liquid Leak Testing	Met all specified criteria
Biocompatibility Evaluation	Met all specified criteria

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

Not Applicable. The described tests are for the physical device's function (e.g., volume, leak, force) and biocompatibility, not for evaluating an AI algorithm's performance on a dataset of patient data. The text states: "All testing was performed on test units representative of finished devices." It does not specify sample sizes for these tests, nor does it refer to patient data or its provenance.

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. Ground truth in the context of expert review is not relevant for the physical device performance tests described.

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

Not Applicable. Adjudication methods for expert review are not relevant here.

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

No. An MRMC study was not conducted as this device is a physical syringe system, not an AI-powered diagnostic or interpretive tool that assists human readers.

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

No. A standalone algorithm performance study was not conducted as this device is a physical syringe system, not an AI algorithm.

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

Not Applicable. The "ground truth" for the device's performance tests would be objective measurements against predefined engineering specifications (e.g., a volume measurement device for volume verification, force gauges for separation force, visual inspection for leakage). It's not clinical "ground truth" established by experts or pathology.

8. The sample size for the training set

Not Applicable. There is no AI algorithm, therefore no training set.

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

Not Applicable. There is no AI algorithm, therefore no training set or ground truth for it.

In summary, the provided document is a 510(k) summary for a physical medical device (Mixing Syringe System) and focuses on its mechanical, functional, and biocompatibility performance. It does not involve any AI components, human reader studies, or the evaluation of an algorithm's diagnostic accuracy.

Summary

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K133021 Page 1 of 2

510(k) Summary

JAN 13 2014

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Device Trade Name:	Mixing Syringe System
Manufacturer:	Zimmer Knee Creations, Inc.841 Springdale Dr.Exton, PA 19341
Contact:	Mr. Shaun HansonAssociate Director of DevelopmentPhone: 484-753-5461Fax: 202-552-5798
Prepared by:	Musculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800
Date Prepared:	December 5, 2013
Common Name:	Piston Syringe
Classification:	21 CFR 880.5860
Class:	II
Product Code:	EME

Indications For Use:

The Mixing Syringe System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Device Description:

Predicate Device:

The Mixing Syringe System has the same indications for use, design, function, materials, and is substantially equivalent to the Arthrex Mixing and Delivery System (K121124) and InFill graft Delivery System (K121476, K111632).

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Performance Standards:

All necessary testing has been performed for the Mixing Syringe System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device design was qualified through the following tests:

Simulated Use Testing ●
Volume Verification .
Separation Force Testing .
Liquid Leak Testing .
Biocompatibility Evaluation .

Conclusion:

The Mixing Syringe System met all specified criteria and did not raise new safety or effectiveness questions. The indications, intended use, and fundamental scientific technology of the Mixing Syringe System are the same as those for the predicate device. Therefore, the Mixing Syringe System is substantially equivalent to the Arthrex Mixing and Delivery System (K121124) and InFill graft Delivery System (K121476, K111632).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Zimmer Knee Creations, Incorporated Mr. Shaun Hanson Associate Director of Development 841 Springdale Drive Exton, Pennsylvania 19341

January 13, 2014

Re: K133021

Trade/Device Name: Mixing Syringe System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: December 6, 2013 Received: December 9, 2013

Dear Mr. Hanson:

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

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Page 2 - Mr. Shaun Hanson

forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

For

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 4.

K133021 510(k) Number (if known):

Device Name: Mixing Syringe System

The Mixing Syringe System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Prescription Use 4 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

for BSA

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K133021

Page 1 of 1

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).