The Nutech Spine and Biologics Anterior Cervical Plate System is interior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc 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, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Device Description

The Anterior Cervical Plate System consists of single level titanium bone plates of various sizes and titanium bone screws in various diameters and lengths to allow for patient specific configurations. The triangular shape of the plate allows for adjacent level fusion without removal of prior Nutech Cervical Plates. Implants are made from Ti 6AI4V ELI, per ATSM F136. The instrumentation allows for simple preparation and placement of the implant construct.

AI/ML Overview

The provided FDA document describes the Nutech Spine and Biologics Anterior Cervical Plate System, which is an implantable medical device, not an AI/ML powered device. Therefore, the information regarding AI/ML device specific acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable.

The document generally outlines the regulatory process for this type of device and refers to performance testing that confirms its structural integrity and mechanical properties.

Here's an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them, tailored to the context of a non-AI medical device:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from FDA Review)	Reported Device Performance (from Summary)
Intended Use Equivalence	Device's intended use must be substantially equivalent to a predicate device.	The subject device is intended for anterior screw fixation to the cervical spine (C2-T1) for specific conditions, matching the predicate.
Indications for Use Equivalence	Device's indications for use must be substantially equivalent to a predicate device.	Indications include degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis, matching the predicate.
Technological Characteristics Equivalence	Device materials, design, and other technological characteristics must be substantially equivalent to a predicate.	The device consists of titanium bone plates and screws made from Ti 6AI4V ELI, similar to the predicate. Documentation confirms substantial equivalence in these aspects.
Performance (Mechanical)	Device must meet established performance standards for static and dynamic mechanical integrity.	Static Compression Bending, Static Torsion, Static Tension Bending, and Dynamic Compression Bending testing (per ASTM F1717-18) confirmed that the Subject device performed as intended.

Study Details (as inferable for a non-AI implantable device)

Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for an AI/ML device. For this implantable device, "test set" refers to the physical devices manufactured and tested for mechanical properties. The document doesn't specify the exact number of physical devices tested but states that testing was performed per ASTM F1717-18 standards. The "provenance" would be the manufacturing lot and controlled laboratory conditions where the mechanical tests were conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of an implantable device, "ground truth" is established by engineering specifications and industry standards (like ASTM F1717-18). The "experts" would be engineering and quality control professionals overseeing the testing, but their specific number and qualifications are not typically detailed in a 510(k) summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials for diagnostic devices or AI systems where human interpretation is involved. For mechanical testing, the results are quantitative measurements against predetermined pass/fail criteria according to ASTM standards.
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: Not applicable. This is a non-AI implantable device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a non-AI implantable device.
The type of ground truth used: For this device, the "ground truth" for performance is based on engineering specifications and established mechanical test standards (ASTM F1717-18) to ensure the device can withstand the forces it will encounter in the body. For safety and substantial equivalence, the primary ground truth is comparison to the legally marketed predicate device.
The sample size for the training set: Not applicable. This is a non-AI implantable device, so there is no training set as understood in AI/ML.
How the ground truth for the training set was established: Not applicable.

Summary

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November 24, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.

Nutech Spine and Biologics % Mr. Daniel Lanois Consultant SurgOp Support 101 Lamond Ct Prosper, Texas 75078

Re: K202972

Trade/Device Name: 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: March 17, 2020 Received: September 30, 2020

Dear Mr. Lanois:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

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)

K202972

Device Name Anterior Cervical Plate System

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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Date Prepared	November 18, 2020
Manufacturer	Nutech Spine and Biologics
Address	600 Luckie Drive, Suite 424, Birmingham, Alabama 35223
Telephone	205-329-7285
Fax	888-475-7793
Contact Person	Daniel Lanois
Address	Consultant
	SurgOp Support LLC
	101 Lamond Ct, Prosper, TX 75078
Telephone	678-371-3605
Fax
Email	daniel@surgopsupport.com
Trade Name	Anterior Cervical Plate System
Common Name	Anterior Cervical Plate System
Panel Code	Orthopedic/87
Classification Name	Spinal Intervertebral Body Fixation Orthosis
Class	Class II
Regulation Number	21 CFR 888.3060
Product Code	KWQ
	Name of Primary Predicate Device	510(k) #	Manufacturer
	Diamond Anterior Cervical Plate System	K100265	Amendia
Description	The Anterior Cervical Plate System consists of single level titanium boneplates of various sizes and titanium bone screws in various diameters andlengths to allow for patient specific configurations. The triangular shape ofthe plate allows for adjacent level fusion without removal of prior NutechCervical Plates. Implants are made from Ti 6AI4V ELI, per ATSM F136. Theinstrumentation allows for simple preparation and placement of the implantconstruct.
Indications andIntended Use	The Nutech Spine and Biologics Anterior Cervical Plate System is intendedfor anterior screw fixation to the cervical spine (C2-T1) for the followingindications: degenerative disc disease (as defined by neck pain of discogenicorigin with degeneration of the disc confirmed by patient history andradiographic studies), trauma (including fractures), tumors, deformity(kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions,spondylolisthesis, and spinal stenosis.
TechnologicalCharacteristics/SubstantialEquivalence	Documentation was provided to demonstrate that the Subject device, issubstantially equivalent to the Predicate. The Subject device is substantiallyequivalent to the Predicate device in intended use, indications for use,materials, technological characteristics, and labeling.
PerformanceData	Static Compression Bending, Static Torsion, Static Tension Bending, andDynamic Compression Bending testing (per ASTM F1717-18) confirmed thatthe Subject device performed as intended.
Conclusion	Based on the intended use, indications for use, technological characteristics,materials, and comparison to Predicate devices, the Subject device has been

510(k) Summary (as required by 21 CFR 807.92)

Regulation Number and Section

N/A