The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Device Description

The Stryker Universal Neuro 3 System comprises of an aluminum module which houses a comprehensive selection of plates, meshes, screws and instrumentation needed to fixate cranial bone flaps. Currently, all devices are provided non-sterile and require cleaning and sterilization prior to implantation. All implants (plates and screws) are single use devices whereas all instruments except for drills (screwdriver handle, blade) can be reused.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Stryker Universal Neuro 3 System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on modifications to an existing device (Stryker Universal Neuro 3 System, K112557). Therefore, the "acceptance criteria" and "reported device performance" are primarily related to proving that these modifications do not negatively impact the safety and effectiveness of the device and that the new features meet specific standards.

Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (SAL): SAL of 10⁻⁶	Achieved through Sterilization validation testing.
Residual (Cleaning): Assurance of reliable cleaning	Confirmed through Residual testing.
Pyrogenicity: Absence of pyrogenic substances	Confirmed through Pyrogenicity testing.
Cytotoxicity: Absence of cytotoxic effects	Confirmed through Cytotoxicity testing.
Packaging and Sealing Validation: Sterility maintained throughout shelf life, considering shipping stresses	Confirmed through Packaging and Sealing validation.
MRI Compatibility: Displacement Force	Confirmed through MRI compatibility testing.
MRI Compatibility: Torque	Confirmed through MRI compatibility testing.
MRI Compatibility: Artifacts	Confirmed through MRI compatibility testing.
MRI Compatibility: Heating under magnetic resonance environment	Confirmed through MRI compatibility testing.
Equivalence to Predicate Device (K112557): Same design, dimensional specifications, and material compositions as the pre-modified version.	Stated that the modified system will have the "exact same design," "same set of plates and screws in same dimensional specifications," and "no change in material compositions" as the predicate device.

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

The document does not provide specific sample sizes for the test sets (e.g., number of units tested for sterility, packaging, or MRI compatibility). It mentions "various verification and validation activities" were performed. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be part of the manufacturer's (Stryker) internal testing and documentation for FDA approval. The studies are prospective in nature, as they are being conducted to validate the modified device's performance.

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

This type of information is not applicable to the studies described. The "ground truth" for these tests (sterility, pyrogenicity, MRI compatibility, etc.) is established by adherence to recognized standards and validated laboratory methodologies, not by expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers (e.g., radiologists assessing medical images). This is not relevant to the laboratory-based and engineering performance testing described for this medical device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to AI-powered diagnostic devices where human readers' performance with and without AI assistance is being evaluated. The Stryker Universal Neuro 3 System is a surgical implant/fixation system, not a diagnostic AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This is also inapplicable as the device is a hardware implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria listed above is based on:

Established Standards and Regulations: For sterility (SAL of 10⁻⁶), pyrogenicity, cytotoxicity, and packaging integrity, there are well-defined international and national standards (e.g., ISO standards, FDA guidance) that dictate the test methods and acceptable limits.
Engineering Specifications: For MRI compatibility, the ground truth is based on the physical properties of the materials and device design, evaluated against established safety limits for the MRI environment.
Predicate Device Performance: A significant aspect of the "ground truth" is that the modified device must perform equivalently to its predicate device (K112557), which was already deemed safe and effective.

8. The Sample Size for the Training Set

There is no "training set" in the context of this device. A training set is used for machine learning algorithms. The Stryker Universal Neuro 3 System is a physical medical device.

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

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

Summary

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K131775 Stryker Universal Neuro 3 System

stryker

750 Trade Centre Way ் செய்வில் பல்கலைக்கு கொண்டுள்ளது.
Portage, MI 490002
1: 269 324 5346 (: 877 648 7114
1: 269 324 5346 (: 877 648 7114
100W 2018 5346 (: 1269 324 5346 1

510(k) Summary of Safety and Effectiveness:

	Stryker Universal Neuro 3 System	OCT 17 2013
--	----------------------------------	-------------

Proprietary Name:	Stryker Universal Neuro 3 System
Common Name:	Neuro Plating System
Classification Name and Reference:	Preformed alterable cranioplasty plate- 21 CFR §882.5320Burr hole cover- 21 CFR §882.5250Cranioplasty plate fastener- 21 CFR §882.5360
Regulatory Class:	Class II
Device Product Code(s):	GWO, GXR and HBW
Predicate devices:	1. Stryker Universal Neuro 3 System(K112557)2. Stryker QuikFlap Sterile Procedure Pack(K120352)
510(k) Contact Person:	Manish PatelStryker Craniomaxillofacial750 Trade Centre Way, Suite 200Portage, MI 49002Phone: 269-389-4271Fax: 877-648-7114manish.patel@stryker.com
Date Prepared:	June 14, 2013

Page 1 of 3

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Traditional 510(k)

Introduction:

This Special 510(k) is being submitted to the U.S. FDA to grant clearance to market the Stryker Universal Neuro 3 System cleared via K 1 12557 with the proposed modifications.

Proposed Modifications:

The only modifications to the existing Stryker Universal Neuro 3 system are:

し、 Change in sterility and packaging to offer the existing cleared implants in a sterile fashion in addition to the current non-sterile version.
1. J Addition of MRI conditional statement to the IFU of the device.

Intended Use:

The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy. craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Device Description:

Technological Characteristics:

The subject Stryker Universal Neuro 3 System when provided sterile with MRI conditional statement, will have the exact same design as its predicate version. Both subject and predicate devices will offer the same set of plates and screws in same dimensional specifications. There will be no change in material compositions as well. All plates and screws will be fabricated from commercially pure grades of titanium.

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Summary of Performance testing:

Various verification and validation activities were performed based on results of the risk analysis to demonstrate that the design outputs of the modified device meets the design input requirements. Activities included - Sterilization to ensure a sterility assurance level of 10° Residual, Pyrogenicity and Cytotoxicity testing to assure reliable cleaning of the devices; Packaging and sealing validation to assure that sterility is maintained throughout shelf life taking into account shipping stresses and lastly, MRI compatibility to study displacement force, torque, artifacts and heating under magnetic resonance environment.

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Image /page/3/Picture/0 description: The image contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The image is a simple black and white image.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

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

October 17, 2013

Stryker Craniomaxillofacial Mr. Manish Patel Senior Regulatory Compliance Analyst 750 Trade Centre Way, Suite 200 Portage, MI 49002

Re: K131775

Trade/Device Name: Stryker Universal Neuro 3 System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: July 18, 2013 Received: July 19, 2013

Dear Mr. Patel:

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 - Mr. Manish Patel

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ReportalProblem/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.

Sincerely yours,

Joyce MWhang -S

Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131775

Device Name: Stryker Universal Neuro 3 System

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).