The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

Device Description

The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The Xenco Medical Multilevel CerviKit plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths.

AI/ML Overview

This document is a 510(k) premarket notification for the Xenco Medical Multilevel CerviKit, a spinal intervertebral body fixation orthosis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided text regarding acceptance criteria and performance study:

The provided document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical device (a spinal implant) whose acceptance is based on demonstrating substantial equivalence to existing predicate devices through non-clinical mechanical testing.

Therefore, many of the typical questions for an AI/ML device's acceptance criteria and study design (e.g., sample size for test set with data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (non-clinical testing) as described in this specific 510(k) submission.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

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

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is that the Xenco Medical Multilevel CerviKit performed "equivalently" to the predicates in the specified non-clinical tests. The specific numerical thresholds for "equivalence" are not detailed in this summary but would be part of the full test reports referenced.

Acceptance Criterion (Implied)	Reported Device Performance
Mechanical performance equivalent to predicate devices	The results of these evaluations indicate that the Xenco Medical Multilevel CerviKit is equivalent to the predicate devices.
Pass Static and dynamic compression testing per ASTM F1717	Conducted and passed.
Pass Static torsion testing per ASTM F1717	Conducted and passed.
Pass Push-out testing for screws	Conducted and passed.

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

Sample Size: Not explicitly stated in this 510(k) summary for the non-clinical tests. Typically, in mechanical testing for a spinal implant, a certain number of samples (e.g., n=5 or more) per test group would be used to establish statistical significance or demonstrate compliance with a standard.
Data Provenance: Not applicable in the sense of patient data. This refers to laboratory-generated mechanical test data.
Retrospective or Prospective: Not applicable. These are in vitro mechanical tests.

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)

Not Applicable. This is not a diagnostic device or an AI/ML algorithm that relies on expert human interpretation of medical images. The "ground truth" for mechanical testing is established by adherence to recognized ASTM standards and engineering principles. The experts involved would be mechanical engineers and biomedical engineers overseeing and conducting the tests.

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

Not Applicable. As this is mechanical testing, there is no human interpretation or adjudication in the medical imaging sense. The test results are quantitative measurements against predefined criteria in the ASTM standards.

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 MRMC study was done. This device is a physical implant, not an AI or imaging diagnostic tool.

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

Not Applicable. This is not an algorithm.

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

Ground Truth for Mechanical Performance: The "ground truth" for demonstrating substantial equivalence is based on established engineering and biomechanical principles captured in ASTM standards (e.g., ASTM F1717) and the established performance characteristics of the predicate devices. The physical properties and mechanical behavior of the device under simulated physiological loads are the "truth" being assessed.

8. The sample size for the training set

Not Applicable. This device does not involve machine learning or a "training set."

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

Not Applicable. As there is no training set for an AI/ML model.

Summary Specific to this Device Submission:

The Xenco Medical Multilevel CerviKit is a Class II medical device. Its acceptance and clearance are based on demonstrating substantial equivalence to legally marketed predicate devices. This equivalence is primarily supported by:

Non-clinical (mechanical) testing: Static and dynamic compression testing (per ASTM F1717), static torsion testing (per ASTM F1717), and push-out testing for screws.
Comparison of design, materials (Titanium alloy - Ti-6Al-4V ELI), and indications for use to predicate devices (K160702 Astura Medical ZION Anterior Cervical Fixation System and K080646 Biomet C-TekV MaxAnrm Anterior Cervical Plate).
No clinical studies were performed.

The "study" that proves the device meets "acceptance criteria" here refers to the in-vitro mechanical testing, where the "acceptance criteria" are implied to be performance results comparable or superior to the predicate devices as per relevant ASTM standards.

Summary

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December 21, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Xenco Medical, LLC % Linda Braddon, PhD President / CEO Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock. Georgia 30188

Re: K213456

Trade/Device Name: Xenco Medical Multilevel CerviKit Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 25, 2021 Received: October 26, 2021

Dear Dr. Braddon:

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. 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)

K213456

Device Name Xenco Medical Multilevel CerviKit

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image is a logo for Xenco Medical. The logo is a green hexagon with the letters "Xm" in white. The word "Xenco" is stacked on top of the word "Medical". The hexagon is made up of smaller triangles of different shades of green.

510(k) Summary: Xenco Medical Multilevel CerviKit

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date Prepared	December 20, 2021
Submitted By	Xenco Medical, LLC9930 Mesa Rim RdSan Diego, CA 92121858-202-1505email: sales@xencomedical.com
Contact	Secure BioMed Evaluations7828 Hickory Flat Hwy, Suite 120Woodstock, GA 30188770-837-2681Contact: Linda Braddone-mail: Regulatory@SecureBME.com
Trade Name	Xenco Medical Multilevel CerviKit
Common Name	Anterior Cervical Plate
Classification Name	Spinal intervertebral body fixation orthosis
Class	II
Product Code	KWQ
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
Primary PredicateDevice	K160702 Astura Medical ZION Anterior Cervical Fixation System
Additional PredicateDevice	K080646 Biomet C-TekV MaxAnrm Anterior Cervical Plate
Reference Devices	K160313 Xenco Medical Cervical Interbody SystemK191074 Xenco Medical Sorrento Bone Graft Substitute
Device Description	The Xenco Medical Multilevel CerviKit is intended for anterior screwfixation of the plate to the cervical spine. The fixation construct consistsof a cervical plate that is attached to the vertebral body of the cervicalspine with bone screws using an anterior approach. Plates are availablein a variety of lengths addressing multiple levels of fixation. The XencoMedical Multilevel CerviKit plate incorporates graft windows on thelongitudinal center line for intraoperative visualization and for screwfixation of bone graft. Fixed or variable bone screws are available in twodiameters and a variety of lengths.
Materials	Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136
SubstantialEquivalence Claimedto Predicate Devices	The Xenco Medical Multilevel CerviKit is substantially equivalent to thepredicate devices in terms of intended use, design, materials used, andmechanical performance.
Indications for Use	The Xenco Medical Multilevel CerviKit is intended for anterior screwfixation to the cervical spine. It is to be used in skeletally mature patientsas an adjunct to fusion of the cervical spine (C2 to T1). The system isindicated for use in the temporary stabilization of the anterior spine duringthe development of cervical spinal fusions in patients with: 1) degenerativedisc disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies), 2) spondylolisthesis, 3) trauma (including fractures ordislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, orscoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinalstenosis.
Non-clinical TestSummary	The following analyses were conducted:• Static and dynamic compression testing per ASTM F1717• Static torsion testing per ASTM F1717• Push-out testing for screwsThe results of these evaluations indicate that the Xenco Medical MultilevelCerviKit is equivalent to the predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Xenco Medical considers the Multilevel CerviKit to be substantiallyequivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation,technology, materials, and indications for use.

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Image /page/4/Picture/0 description: The image is a logo for Xenco Medical. The logo is a green hexagon with the text "Xenco Medical" written in white. The "X" is larger than the rest of the text. The hexagon is made up of smaller triangles of varying shades of green.

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.