Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and 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)trauma (including fractures); 3)tumors: 4)deformity(defined as kyphosis, lordosis,or scoliosis); 5)pseudoarthrosis; 6)failed previous fusions

Device Description

Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.

Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.

Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

AI/ML Overview

This document, K223753, is a 510(k) premarket notification for a Cervical Plate System. It seeks to demonstrate substantial equivalence to a legally marketed predicate device (K141632 ZEVO™ Anterior Cervical Plate System).

The request asks for acceptance criteria and a study that proves the device meets these criteria. However, the provided text does not contain information about an AI/ML-based medical device, nor does it describe a study involving human-in-the-loop performance, expert consensus on images, or training/test sets for an algorithm.

Instead, this submission details the regulatory approval process for a physical orthopedic implant used in spinal surgery. The "acceptance criteria" discussed are primarily related to biocompatibility and mechanical testing of the physical device to ensure its safety and efficacy, not performance metrics of an AI algorithm.

Therefore, I cannot provide the requested information. The document explicitly states:

"No clinical performance data was provided to demonstrate substantially equivalence." (Section 5.8)
The non-clinical performance data focuses on biocompatibility testing (ISO 10993-1) and mechanical testing (ASTM F1717) for the physical implant (Static compression bending test, Static torsion test, Dynamic compression bending test).

To explicitly answer your questions based only on the provided text, and acknowledging the mismatch with your request for AI/ML study details:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied from tests performed): The Cervical Plate System must demonstrate biocompatibility and mechanical performance (static compression bending, static torsion, dynamic compression bending) that is substantially equivalent to the predicate device, as per ASTM F1717 and ISO 10993-1.
- Reported Device Performance: The document states these tests were "performed... to demonstrate substantially equivalent of safety and efficacy with the predicate device," but it does not provide numerical results or specific performance metrics from these tests. It only states that the information provided "demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device." This implies the acceptance criteria were met, but the specific data is not in this summary.
Sample sizes used for the test set and the data provenance: This is not applicable to this document as it does not describe an AI/ML study with test sets of data. The "test set" here refers to physical samples of the cervical plate subjected to mechanical and biocompatibility tests. No information on the number of physical samples tested is provided, nor is the "provenance" of such samples described in terms of geographical origin or retrospective/prospective collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth, in the context of an AI/ML study, would involve expert labeling of medical images or data. No such process is described for this physical device. The "ground truth" for a physical device is its material properties and mechanical behavior under stress.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable as there is no data labeling or consensus-building process for an AI/ML system.
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: This is not applicable to this submission. The device is a physical implant, not an AI assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. There is no algorithm described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" refers to established material properties and biomechanical standards. The document refers to ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ISO 10993-1 (Biological evaluation of medical devices). These standards serve as the "ground truth" for evaluating the physical and biological characteristics of the device.
The sample size for the training set: This is not applicable as there is no AI/ML model or training set.
How the ground truth for the training set was established: This is not applicable as there is no AI/ML model or training set.

In summary, the provided document is a 510(k) summary for a physical medical device (Cervical Plate System) and does not involve AI/ML technology or studies with expert reading of medical images.

Summary

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March 14, 2023

Double Medical Technology Inc. Yan Zuo International RA Supervisor No. 18, Shanbianhong East Road, Haicang District Xiamen. Fujian 361026 China

Re: K223753

Trade/Device Name: Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 8, 2022 Received: December 14, 2022

Dear Yan Zuo:

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,

Colin O'neill -S

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) K223753

Device Name Cervical Plate System

Indications for Use (Describe)

2)trauma (including fractures);

3)tumors:

4)deformity(defined as kyphosis, lordosis,or scoliosis);

5)pseudoarthrosis;

6)failed previous fusions

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)

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K223753- 510(k) Summary

5.1 Submitter
Name	Double Medical Technology Inc.
Address	No. 18, Shanbianhong East Road, Haicang District, Xiamen,361026, P. R. China
Phone	+86 592 6885079
Contact person	Yan Zuo
Date prepared	March 10th, 2023
5.2 Proposed Device
Trade/proprietary name	Cervical Plate System
Common or usual name	Cervical Plate System
Classification name	Spinal Intervertebral Body Fixation Orthosis
Regulation number	21 CFR 888.3060
Product code	KQW
Regulatory class	II
Classification panel	Orthopedic
5.3 Predicate Device
Legally marketeddevice(s) to whichequivalence is claimed	Primary predicate device:K141632 ZEVO™ Anterior Cervical Plate System
Reason for 510(k)submission	New device(Implant)

K223753- 510(k) Summary

5.4 Device Description

Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

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5.5 Indication for Use

(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) trauma (including fractures);
(3) tumors;
(4) deformity(definedaskyphosis, lordosis,or scoliosis);
(5) pseudoarthrosis;
(6) failed previous fusions.

5.6 Comparison of Technological Characteristics with the Predicate Device

The rationale for substantial equivalence is based on consideration of the following characteristics:

Regulatory Classification: Same as the predicate devices

Indications for Use: Substantially equivalent (SE) to the predicate devices

Materials: Substantially equivalent (SE) to the predicate devices

Design Features: Substantially equivalent (SE) to the predicate devices

5.7 Non-Clinical Performance Data

5.7.1 Biocompatibility testing

The biocompatibility evaluation for the Cervical Plate System was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

5.7.2 Mechanical testing

The following tests were performed (per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model on Anterior Cervical Spine Plate System to demonstrate substantially equivalent of safety and efficacy with the predicate device.

Static compression bending test
Static torsion test
Dynamic compression bending test

5.8 Clinical Data

No clinical performance data was provided to demonstrate substantially equivalence.

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5.9 Conclusion

The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) 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.