The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis.
trauma (i.e. fractures or dislocations),
tumors,
deformity (defined as kyphosis, lordosis, or scoliosis),
pseudoarthrosis,
failed previous fusion,
spinal stenosis.

The Elatus Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an aqunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

Device Description

The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.

The Elatus Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Elatus Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

AI/ML Overview

The provided text is a 510(k) summary for the Paeon Anterior Cervical Plate System and Elatus Lumbar Plate System. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared predicate devices.

**However, this document does not describe:

Acceptance criteria in terms of performance metrics for an AI/ML powered device.
A study proving the device meets specific acceptance criteria using a test set of data.
Details about sample sizes, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for data-driven performance evaluation.**

This document is a regulatory submission for spinal intervertebral body fixation orthoses, which are physical medical devices (implants for spinal fusion), not AI/ML-powered software devices. The "performance testing" section explicitly states that "The additional components added in this submission do not require additional mechanical testing." and refers to substituting mechanical test data from predicate devices. This is typical for physical devices demonstrating substantial equivalence based on material, design, and manufacturing process similarity to existing devices.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML-based device from the provided text. The questions posed in the prompt (e.g., "Number of experts used to establish the ground truth", "MRMC comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document pertains to.

Summary

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January 11, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Aegis Spine, Inc. Kihyang Kim RA 9781 S. Meridian Blvd. Ste 300 Englewood, Colorado 80112

Re: K223719

Trade/Device Name: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 9, 2022 Received: December 12, 2022

Dear Kihyang Kim:

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,

Anne D. Talley -S
for

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) K223719

Device Name

Paeon Anterior Cervical Plate System

Indications for Use (Describe)

· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis.
· trauma (i.e. fractures or dislocations),
tumors,
· deformity (defined as kyphosis, lordosis, or scoliosis),
· pseudoarthrosis,
· failed previous fusion,
· spinal stenosis.

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

Residential Use (24 CFR 982 Subpart M)

Day Care Operation (24 CFR 982 Subpart G)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223719

Device Name

Elatus Lumbar Plate System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1.

Submitter's Name:	Aegis Spine, INC.
Submitter's Address:	9781 S. Meridian Blvd, Ste 300Englewood, CO 80112
Submitter's Telephone:	+1.303.741.4123
Contact Person:	Kihyang Kim+1.303.741.4123khkim@aegisspine.com khkim3747@gmail.com
Date Prepared:	January 10, 2023

DEVICE IDENTIFICATION 2.

Device Trade Name	Paeon Anterior Cervical Plate System
Common/Usual Name	Appliance, Fixation, Spinal Intervertebral Body
Regulation Class /Number	Class II / 21 CFR 888.3060
Regulation Name	Spinal Intervertebral Body Fixation Orthosis
Product Code	KWQ
Classification Panel	Spinal Devices (DHT6B)

Device Trade Name	Elatus Lumbar Plate System
Common/Usual Name	Lumbar Spinal Plate
Regulation Class /Number	Class II/ 21 CFR 888.3060
Regulation Name	Spinal Intervertebral Body Fixation Orthosis
Product Code	KWQ
Classification Panel	Spinal Devices (DHT6B)

3. PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT.

The subject devices are identical to the predicate devices in all characteristics.

Subject Device Name	510K NO.	Trade or Proprietary or Model Name	Predicate Type
PAEON AnteriorCervical Plate System	K 221050	Paeon Anterior Cervical Plate System,Spinema Lumbar Plate System.	Primary
	K 210035	Paeon Anterior Cervical Plate System,Spinema Lumbar Plate System.	Additional
	K 143271	CastleLoc Anterior Plate System	Additional
	K 190425
Elatus Lumbar PlateSystem	K 221050	Paeon Anterior Cervical Plate System,Spinema Lumbar Plate System.	Primary
	K 210035	Paeon Anterior Cervical Plate System,Spinema Lumbar Plate System.	Additional
	K 142699	LITe Plate System	Additional
	K 143626	Trinica® Anterior Lumbar Plate System	Additional

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The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices.

4. MATERIALS

Paeon Anterior Cervical Plate System	Ti-6Al-4V ELI titanium alloy (ASTM F136)
Elatus Lumbar Plate System	Ti-6Al-4V ELI titanium alloy (ASTM F136)

And the additional components material is the same material used in the predicate devices (K 210035 K 221050).

న్. DESCRIPTION OF THE DEVICE

6. INDICATION FOR USE

degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
. spondylolisthesis,
. trauma (i.e., fractures or dislocations),
. tumors.
. deformity (defined as kyphosis, lordosis, or scoliosis),
. pseudoarthrosis,
. failed previous fusion,
spinal stenosis.

The Elatus Lumbar Plate System is indicated for use via the anterior, lateral, or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

7. PERFORMANCE TESTING

Paeon Anterior Cervical Plate System

The additional components added in this submission do not require additional mechanical testing. None of the additional components is the worst case of the Paeon Anterior Cervical Plate System.

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Elatus Lumbar Plate System

The additional components added in this submission do not require additional mechanical testing. None of the additional components is the worst case of the Elatus Lumbar Plate System.

Therefore, we substitute mechanical test data of Paeon Anterior Cervical Plate System and Elatus Lumbar Plate System for additional components with the predicate device data (K210035/K221050).

8. SUMMARY OF TECHNOLOGY CHARACTERISTICS

Subject devices are identical to the predicate devices in all (design feature, indications for use, surgical approach and manufacturing process) characteristics.

9. SUBSTANTIAL EQUIVALENCE

Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, function, and materials used.

10. CONCLUSION

The overall technology characteristics lead to the conclusion that the Paeon Anterior Cervical Plate System, and Elatus Lumbar Plate System is substantially equivalent to the predicate devices (K210035/K221050).

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.