The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects. The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Alliance Spine RAAS Cranial Plating System. This type of submission is focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device), rather than proving the device meets explicit acceptance criteria through a standalone clinical study like a De Novo application might.

Therefore, the structure of the response will reflect that the "acceptance criteria" are essentially the performance characteristics of the predicate devices, and the "study" is the non-clinical testing demonstrating similar performance.

Acceptance Criteria and Study for the Alliance Spine RAAS Cranial Plating System (K141123)

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly derived from the performance of the predicate devices. The new device is considered substantially equivalent if its performance is comparable.

Performance Attribute (Implicit Acceptance Criteria based on Predicate Devices)	Alliance Spine RAAS Cranial Plating System Performance (Reported)
Mechanical Strength (Static Axial Compression): Peak load and stiffness comparable to predicate burr hole plates.	Peak load and stiffness values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
Screw Insertion/Removal Torque: Driving torque values comparable to predicate screws.	Driving torque values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
Screw Ultimate Torque: Peak torque values comparable to predicate screws.	Peak torque values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
Screw Axial Pullout Strength: Peak load values comparable to predicate screws.	Peak load values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
Material Composition: Use of biocompatible materials (ASTM F136, ASTM F67).	Plates and Burr Hole Covers - ASTM F136; Mesh - ASTM F67; Screws - ASTM F136. All consistent with predicate materials.
Dimensions (Thickness): Comparable plate and mesh thicknesses to predicate devices.	Plates & Burr Hole Covers - 0.5mm; Mesh - 0.3mm and 0.6mm. Comparable to predicate range (e.g., 0.25 to 1.0mm, 0.1 to 0.6mm).
Sterilization Method: Compatibility with standard sterilization methods.	End User (steam) sterilization.

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

Test Set Sample Size: The document does not specify a precise sample size for each test (e.g., number of burr hole plates or screws tested). It refers to "Worst case Burr Hole plates" and "Worst case screws," implying a representative selection but not a fixed number.
Data Provenance: The data is generated from non-clinical bench testing, conducted specifically for this 510(k) submission. The location of the testing is not specified. It is a prospective generation of data for the submission.

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

This information is not applicable (N/A) in this context. For a 510(k) submission, the "ground truth" for mechanical performance is established through adherence to recognized international and national standards (e.g., ASTM F382, ASTM F543) and comparison to the known performance of predicate devices. There wouldn't be a panel of human "experts" establishing a ground truth for mechanical test results in the same way they might for clinical interpretations.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Mechanical testing results are objective measurements against defined standards and predicate performance, not subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a cranial plating system, a physical implant, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This information is not applicable (N/A). This product is a physical medical device (cranial plating system), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence in this 510(k) is:

Adherence to recognized industry standards: ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
Performance metrics of predicate devices: The tests were designed to show that the subject device's mechanical properties (e.g., peak load, stiffness, torque values) were "acceptable based on intended use and predicate data," implying that the predicate's performance served as the benchmark.

8. The Sample Size for the Training Set

This information is not applicable (N/A). As this is a physical medical device without any AI/machine learning components, there is no "training set."

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

This information is not applicable (N/A), as there is no training set for this type of device.

Summary

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

February 27, 2015

Alliance Partners, LLC % Mr. Kellen Hills Quality & Regulatory Consultant Orchid Design. A Division of Orchid Orthopedic Solutions 4600 East Shelby Drive, Suite 1 Memphis. TN 38118

Re: K141123

Trade/Device Name: Alliance Spine RAAS Cranial Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: February 20, 2015 Received: February 25, 2015

Dear Mr. Kellen Hills,

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

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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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS 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) K141123

Device Name RAAS Cranial Plating System

Indications for Use (Describe)

The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.

Type of Use (Select one or both, as applicable)

For Activities Under CEE 301.5(c)	For Site Controls Under CEE 301.5(d)
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X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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(a)(1)	Submitted By:	Alliance Partners, LLC(dba Alliance Spine™)14206 Northbrook Dr.San Antonio, TX 78232
	Date:	February 20, 2015
	Contact Person:	Tim M. LohnesSenior Regulatory ConsultantOrchid Design
	Phone:Fax:	203-922-0105203-922-0130
(a)(2)	Proprietary Name:	RAAS Cranial Plating System
	Common Name:	Bone Plates, Bone Fixation Fasteners
	Classification Names and References:	882.5320 - Preformed alterablecranioplasty plate882.5250 - Burr hole cover882.3560 - Cranioplasty plate fastener
	Product Codes:	GWO, GXR, HBW
(a)(3)	Predicate Devices:	Stryker-NEURO II (K031659)OsteoMed-Low Profile Neuro (K111176)
	SUBJECT DEVICE	PREDICATE DEVICES
Manufacturer	Alliance Spine	Stryker	OsteoMed
System Name	RAAS CranialPlating System	Neuro 2 Cranial PlateSystem	Low Profile NeuroFixation System
510(k)	Subject	K031659	K111176
Product Codes	GWO, GXR, HBW	JEY, HWC	GWO, GXR
Indications for Use	The RAAS CranialPlating System isindicated forosteotomy,craniotomy,cranial fractures,andreconstruction ofnon-load bearingcranial areas.	The Stryker LeibingerUniversal NeuroSystem is a low-profile plate andscrew systemintended forosteotomy,craniotomy,stabilization and rigidfixation of craniofacialfractures andreconstruction ofnon-load bearingareas.	The OsteoMedLowProfile NeuroFixation System isindicated for use inostemtomies,fractures orreconstruction ofcranial bones.Implants and drillsare single use only.
Sterilization	End User (steam)	Non-sterile and sterile	Not specified
Shelf Life	n/a	Not specified	Not specified
Implant Material:
Plates andBurr Hole Covers -	ASTM F136	CP Ti	ASTM F136/F67
Mesh –	ASTM F67	CP Ti	ASTM F136/F67
Screws -	ASTM F136	Ti Alloy	ASTM F136
Thickness:
Plates & Burr HoleCovers -	0.5mm	0.6 and 0.5mm	0.25 to 1.0mm
Mesh -	0.3 and 0.6mm	0.1, 0.2, 0.3 and0.6mm	0.25 to 1.0mm
SurfaceTreatment:Plates & Burr HoleCovers	None	Type III Anodized	Not specified
SurfaceTreatment: Mesh	Type III Anodized	Type III Anodized	Not specified
Screws - type	Self-tapping,drilling, andrescue	Self-tapping, drilling,and rescue	"Auto Drive" andrescue
Screws:diameter/length	1.5 x 4 & 5mm,1.7 x 5 & 6mm	1.5mm x 4, 5 & 6mm1.7mm x 4mm	1.6mm x 4, 5, 6 & 8mm, 1.9mm x 4, 5, 6 & 8mm
SurfaceTreatment: Screws	Type III Anodized	Type III Anodized	Not specified

Device Description: (a)(4)

The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.

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The Alliance Spine™ RAAS Cranial Plating System is indicated for osteotomies, craniotomy, cranial fractures, and reconstruction of non-load bearing cranial areas.

Technological Characteristics: (a)(6)

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(b)(1) Non-clinical testing:

Test	Test Method Summary	Results
Static Axial Compression	Worst case Burr Hole plateswere subjected to loading asdescribed in ASTM F382.	Peak load and stiffness valueswere acceptable based onintended use and predicate data.Subject device expected toperform similarly to predicate.
Insertion/Removal Torque	Worst case screws wereinserted into and thenremoved from a test block asdescribed in ASTM F543.	Driving torque values wereacceptable based on intendeduse and predicate data. Subjectdevice expected to performsimilarly to predicate.
Ultimate Torque	Worst case screws were fixedbelow the head and subjectedto loading as described inASTM F543.	Peak torque values wereacceptable based on intendeduse and predicate data. Subjectdevice expected to performsimilarly to predicate.
Axial Pullout	Worst case screws wereinserted to a fixed depth andsubjected to loading asdescribed in ASTM F543.	Peak load values were acceptablebased on intended use andpredicate data. Subject deviceexpected to perform similarly topredicate.

Clinical testing: (b)(2)

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

(b)(3) Conclusions:

Based on the information provided in this premarket notification, we believe that the subject RAAS Cranial Plating System demonstrates substantial equivalence and has a safety and effectiveness profile that is similar to the identified predicate devices.

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).