The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

Device Description

The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.

AI/ML Overview

The provided text is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and its technological characteristics. However, the document does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or MRMC studies for a device with those functionalities.

The performance data mentioned in the document is exclusively for non-clinical mechanical testing of the implant's structural integrity. Therefore, I cannot provide the requested information related to the acceptance criteria and study that proves a device meets diagnostic performance criteria because such data is not present in the provided text.

The closest information related to "acceptance criteria" is that the device was tested per ASTM F1717 for mechanical properties and the results showed "sufficient" strength and substantial equivalence to predicate devices.

Here's an overview of what is in the document regarding performance, and why it doesn't match your request:

Performance Data Section from Document:
"The Axis Anterior Cervical Plate System has been tested in the following test modes:

Static & Dynamic Compression Bending per ASTM F1717
Static Torsion per ASTM F1717
The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This information pertains to material science and mechanical engineering, not diagnostic accuracy or AI performance.

Therefore, I cannot populate the table or answer the questions related to diagnostic performance or AI effectiveness.

Summary

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June 13, 2023

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Southern Medical (Pty) Ltd % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K231145

Trade/Device Name: Axis 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: April 21, 2023 Received: April 21, 2023

Dear Nathan 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 medical devices and radiation-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,

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Colin O'Neill, M.B.E. 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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Indications for Use

510(k) Number (if known) K231145

Device Name

Axis Anterior Cervical Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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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K231145 - 510(K) SUMMARY

Submitter's Name:	Southern Medical (Pty) Ltd
Submitter's Address:	55 Regency DriveRoute 21 Corporate ParkIrene, Centurion, Gauteng 0178South Africa
Submitter's Telephone:	+27 12 667 6243/4
Contact Person:	Nathan Wright MSEmpirical Technologies1-719-351-0248nwright@empiricaltech.comImage: Empirical Technologies logo
Date Summary was Prepared:	April 21, 2023
Trade or Proprietary Name:	Axis Anterior Cervical Plate System
Common or Usual Name:	Anterior Cervical Plate System
Classification Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification:	Class II per 21 CFR §888.3060
Product Code:	KWQ
Classification Panel:	Orthopedic – Spinal (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Axis Anterior Cervical Plate System is intended for use in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours: (d) deformity (defined as kyphosis, lordosis or scoliosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

TECHNOLOGICAL CHARACTERISTICS

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
Structural support mechanism ●
Materials of manufacture ●
Sizes and features ●

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Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	ProductCode	PredicateType
K201979	Cervical Plate System	Eminent Spine, LLC	KWQ	Primary
K132994	Anodyne Anterior CervicalPlate System	CoreLink, LLC	KWQ	Additional

Performance Data

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

Static & Dynamic Compression Bending per ASTM F1717 ●
Static Torsion per ASTM F1717 ●

The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Axis 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.