The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:

Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
o Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
Pseudoarthrosis ●
Failed previous fusions ●
Spondylolisthesis ●
Spinal Stenosis ●

Device Description

The Medina Anterior Cervical Plate System (ACP) System is intended for anterior screw fixation to the cervical spine. The Medina ACP system consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and commercially pure titanium per ASTM F67. Components of the Medina ACP System should not be used with components from any other system or manufacturer, with exception of the Cage Pins which are to be used only with Alliance Spine's Alamo C or Alamo C-Ti systems. The Medina ACP System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.

AI/ML Overview

The provided text describes a medical device, the Medina Anterior Cervical Plate System, and its substantial equivalence determination by the FDA. However, the text does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in relation to an AI algorithm.

The information provided focuses on:

Regulatory Clearance (K201521): The FDA's substantial equivalence determination for the Medina Anterior Cervical Plate System.
Device Description: What the device is, its materials, and intended use.
Indications for Use: The medical conditions for which the device is intended.
Technological Characteristics: Comparison to predicate devices.
Performance Data (Non-Clinical): Mechanical testing (static compression bending, static torsion, dynamic compression bending) against ASTM F1717, concluding substantial equivalence to predicate devices in terms of strength.

Therefore, I cannot provide the requested table and study details as they pertain to AI algorithm performance and acceptance criteria, as this information is not present in the provided document.

The document describes a physical medical device (an anterior cervical plate system) and its mechanical performance testing, not an AI or software-as-a-medical-device (SaMD) product.

Summary

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August 6, 2020

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Alliance Partners, LLC % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K201521

Trade/Device Name: Medina Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 5, 2020 Received: June 8, 2020

Dear Mr. Wright:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement on last page.
510(k) Number (if known)K201521
Device Name
Medina Anterior Cervical Plate System
Indications for Use (Describe)

Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
o 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)
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Submitter's Name:	Alliance Partners, LLC
Submitter's Address:	14206 Northbrook DriveSan Antonio, Texas 78232
Submitter's Telephone:	210-314-2525
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	June 5, 2020
Trade or Proprietary Name:	Medina Anterior Cervical Plate System
Common or Usual Name:	Anterior Cervical Plate System
Classification:	Class II per 21 CFR §888.3060
Product Code:	KWQ
Classification Panel:	Orthopedic and Rehabilitation Devices

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures) ●
Tumors ●
o Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudoarthrosis ●
Failed previous fusions ●
Spondylolisthesis ●
Spinal Stenosis ●

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TECHNOLOGICAL CHARACTERISTICS

The Medina Anterior Cervical Plate System is made from titanium alloy per ASTM F136 and commercially pure titanium per ASTM F67. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

. Indications for Use
Materials of manufacture ●
Structural support mechanism ●
. Sizes

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K141993	Nakoma ACP	Alliance Partners, LLC	Primary
K060025	Slimplicity Anterior Cervical Plate System	Spinal USA	Additional
K091936	BladeTM Anterior Cervical Plate System	Nexxt Medical, Inc.	Additional

PERFORMANCE DATA

The Medina Anterior Cervical Plate System has been tested in the following test modes:

Static compression bending per ASTM F1717 ●
Static torsion per ASTM F1717
Dynamic compression bending per ASTM F1717 ●

The results of this non-clinical testing show that the strength of the Medina Anterior Cervical Plates System is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Medina Anterior Cervical Plate System is substantially equivalent to the predicate device.

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.