The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:
• Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal Stenosis

Device Description

The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included.

The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).

AI/ML Overview

This document is a 510(k) premarket notification for the Nakoma ACP System, a spinal intervertebral body fixation orthosis. It includes information about the device's indications for use, its comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in a pass/fail quantifiable manner, but it does describe the non-clinical testing performed and the conclusion drawn from it. The "acceptance criteria" here are implied to be "perform equivalently to the predicates" as verified by the stated tests.

Acceptance Criteria (Implied)	Reported Device Performance
Static Compression equivalent to predicates (per ASTM F1717)	"the subject devices were found to perform equivalently to the predicates."
Static Torsion equivalent to predicates (per ASTM F1717)	"the subject devices were found to perform equivalently to the predicates."
Dynamic Compression equivalent to predicates (per ASTM F1717)	"the subject devices were found to perform equivalently to the predicates."

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

The document mentions "non-clinical testing" and refers to ASTM F1717 for mechanical tests. It states "the subject devices were found to perform equivalently to the predicates." However, it does not specify the sample size used for these tests. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as these are mechanical tests, not clinical data from patients.

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)

This question is not applicable to the provided document. The device in question is a medical implant (spinal fixation system), and the evaluation discussed is based on non-clinical mechanical testing (ASTM F1717). Therefore, there is no "ground truth" derived from expert consensus on medical images or patient outcomes in this context.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where disagreements need to be resolved. This document focuses on non-clinical mechanical testing, which does not involve subjective interpretations requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states under "(b)(2) Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The device is a spinal implant, not an AI-assisted diagnostic tool for human readers.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical medical implant, not a software algorithm.

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

The "ground truth" for the non-clinical testing was based on the established performance characteristics and specifications of the predicate devices as determined by ASTM F1717 standards for mechanical testing. The goal was to show equivalence to these established benchmarks.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence of a physical medical device through mechanical testing, not on developing or training an algorithm.

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

This question is not applicable, as there is no training set involved in this submission.

Summary

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

November 6, 2014

Alliance Partners, LLC % Ms. Kellen Hills Quality & Regulatory Consultant Orchid Design 4600 East Shelby Drive Memphis, Tennessee 38118

Re: K141993

Trade/Device Name: Nakoma ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 8, 2014 Received: August 11, 2014

Dear Ms. 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kellen Hills

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/Resourcesfor You/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 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 vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K141993

Device Name Nakoma ACP system

Indications for Use (Describe)

spine fusion in patents with the following indications:
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• Degenerative Disk Disease	(as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma	(including fractures)
• Tumors
• Deformities or curvatures	(including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal Stenosis

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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(a)(1)	Submitted By:	Alliance Partners, LLC
		14206 Northbrook Dr.
		San Antonio, TX 78232
	Phone:	210-314-2525
	Fax:	210-314-2524
	Date:	November 6, 2014
	Contact Persons
	Primary:	Kellen Hills (Orchid Design Consulting)
	Secondary:	Frank Morris (Alliance Partners, LLC)
(a)(2)	Proprietary Name:	Nakoma ACP
	Common Name:	Anterior Cervical Plate
	Classification Name and Reference:	21CFR 888.3060 - Spinal intervertebral body
		fixation orthosis
	Product Code:	KWQ
(a)(3)	Predicate Devices:

redicate Devices Custom Spine-REGENT (K091134) Primary: Secondary: Aesculap-QUINTEX (K100243)

Device Description: (a)(4)

The purpose of this submission is to gain initial marketing authorization in the United States.

(a)(5) Indications for Use:

Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis or scoliosis)
· Pseudoarthrosis
Failed previous fusions
Spondylolisthesis

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Spinal Stenosis
(a)(6) Comparison of Technological Characteristics:
- The fundamental scientific technology, materials of construction and mechanism of operation is the same between the subject Nakoma ACP and predicate Regent ACP device. Both are intervertebral fusion devices, designed to provide support and stabilization in order to achieve fusion between adjacent vertebrae. Both subject and predicate devices are made from titanium alloy and incorporate retention clips and multiple screw options. Both subject and predicate devices offer plates and screws in comparable size ranges. Both devices utilize instrumentation common to spinal fusion surgery.

Additionally, Aesculap's QUINTEX system was used as a dimensional predicate for the Level 5 plates of the subject Nakoma ACP system.

(b)(1) Non-clinical testing:
Testing in accordance with ASTM F1717 (i.e., static compression, static torsion, dynamic compression) was conducted and the subject devices were found to perform equivalently to the predicates.

(b)(2) Clinical testing:

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 and the details specified in FDA guidance "Spinal System 510(k)s", we believe that the subject Nakoma ACP system is as safe, as effective, and performs as well as or better than the predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.