This is a 510(k) premarket notification for a medical device (Zimmer® Plates and Screws System (ZPS) - Screws only) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through clinical trials. Therefore, much of the requested information regarding AI models, comparative effectiveness studies, and detailed ground truth establishment is not applicable to this type of submission.

However, I can provide the available information from the document that aligns with your request for acceptance criteria and study data related to the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance / Conclusion
Sterilization Validation: Achieve a minimum gamma dose of 20kGy and a Sterility Assurance Level (SAL) of $10^{-6}$ or better.	The devices can be terminally sterilized to a SAL of $10^{-6}$ or better.
Shelf Life: Product has a specified shelf life.	Accelerated aging showed that the product has a shelf life of 10 years.
Sterile Packaging: Withstand normal distribution and storage conditions and maintain sterile barrier properties throughout the specified product shelf life.	(Implied to have met, as device is provided sterile) To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
Biocompatibility: Tested per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58).	All testing passed.
Mechanical Performance (through engineering evaluations and nonclinical lab testing): Address differences in screw diameters, partial vs. full threads, starting load, material strength, and drive types. Include cross-sectional analysis, fatigue failure, insertion torque, and torque to failure.	The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

Note: The document explicitly states: "Clinical data and conclusions were not needed for this device." This immediately tells us that a clinical study as typically defined for efficacy or safety of a new drug or novel device was not performed. The focus is on non-clinical performance to show substantial equivalence.

Information on AI-specific questions (not applicable to this document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no clinical test set for AI. The non-clinical tests involved specific numbers of samples for each mechanical or biological test, but these are not reported in detail in this summary.
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, no expert-based ground truth for AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no test set requiring adjudication in this context.
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, this is a hardware device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a hardware device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For non-clinical tests, the "ground truth" is defined by the objective measurement criteria of the specific ASTM or ISO standards used (e.g., specific torque values, fatigue cycles, SAL values, cytocompatibility metrics).
The sample size for the training set: Not applicable, no AI training set.
How the ground truth for the training set was established: Not applicable, no AI training set.

Summary of the Study (Non-Clinical Performance):

The performance of the Zimmer® Plates and Screws System (ZPS) - Screws only, to demonstrate substantial equivalence, relied entirely on non-clinical performance testing and engineering evaluations. These included:

Sterilization Validation: Demonstrated the device could be terminally sterilized to a SAL of $10^{-6}$ or better using a minimum gamma dose of 20kGy.
Shelf Life Testing: Accelerated aging studies were conducted, concluding a 10-year shelf life.
Sterile Packaging Testing: Designed to ensure the integrity of the sterile barrier under normal distribution and storage conditions for the specified shelf life.
Biocompatibility Testing: Performed on the screw material according to ISO 10993-1 and 21 CFR § 58 (Good Laboratory Practices), with all tests passing.
Engineering Evaluations and Mechanical Testing: This included analysis of various screw characteristics (diameters, thread types, starting load, material strength, drive types) and specific tests like cross-sectional analysis, fatigue failure, insertion torque, and torque to failure.

The conclusion drawn from these non-clinical studies was that the devices are safe and effective and substantially equivalent to the predicate devices. No clinical studies were deemed necessary due to the nature of the device (temporary internal fixation) and the demonstration of equivalence through non-clinical means.

Summary

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Sponsor:

Date:

Trade Name:

Common Name:

and References:

Predicate Devices:

Classification Names

Contact Person:

DEC 1 9 2011

P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131

510(k) Summary

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760

December 19, 2011

Zimmer® Plates and Screws System (ZPS) - Screws only

Temporary Internal Fixation Devices

Single/multiple component metallic bone fixation appliances and accessories - 21 CFR 888.3030, Smooth or threaded metallic bone fixation fastener - 21 CFR 888.3040

Synthes 1.5mm Mini Fragment LCP System (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K060710, K082527), Synthes 6.5mm Cancellous Screws (K061621), Pioneer Cannulated Screw System (washer - K003496) and DePuy ACE Composite Locking Nut (K983265).

Device Description: Temporary internal fixation devices, such as the ZPS screws, are designed to stabilize fractures during the normal healing process.

Intended Use: Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

Comparison to Predicate Device: The ZPS Screws are similar in intended use, screw diameter, thread and drive types, and performance characteristics to the predicate devices. The proposed screws are provided sterile vs. non-sterile.

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

. Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL of 10to or better.
. Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
. Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
◆ Biocompatibility - Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.

Providing these screws pre-sterilized did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.

The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, material strength and the differences between the drive types. Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The bird is composed of curved lines that create a sense of movement. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

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

Zimmer Inc. % Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708

DEC 1 9 2011

Re: K112885

Trade/Device Name: Zimmer® Plates and Screws System (ZPS) – Screws Only Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: September 29, 2011 Received: September 30, 2011

Dear Mr. McKelvey:

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 r trade of a rised 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 or uny 1 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 Of ICP and 607), lacemig (21 CFR 803); good manufacturing practice requirements as set

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Page - 2 - Mr. Stephen H. McKelvey

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 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,
Erin Keith

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

Enclosure

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Indications for Use

510(k) Number (if known): K 112885 (pg 1/1)

Device Name:

Zimmer 9 Plates and Screws System (ZPS) - Screws only

Indications for Use:

Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

for March Mekkuser

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112885

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.