The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:

-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies)

-Spondylolisthesis

-Fracture
-Spinal stenosis

-Tumors (primary and metastatic)

-Failed previous fusions

-Pseudoarthrosis

-Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

Device Description

The Eisertech, LLC. Cervical Plate (K113170) is a spinal internal fixation device which is provided in a variety of sizes ranging from 20mm in length. The device is designed to accommodate fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. Instrumentation to facilitate implantation of the cervical plate is included with the device. This instrumentation is the subject of the present Traditional 510(k) submission. Specifically, the present Traditional 510(k) submission seeks to add two additional base material options as well as a surface treatment to all previously cleared instruments for use with the cervical plate system. The purpose of the surface treatment is to add scratch resistance and hydrophobicity to the instruments. There are no changes to the implants and the surface treatment is not being applied to the implants.

AI/ML Overview

This document is a 510(k) summary for a medical device called a "Cervical Plate". However, the submission K190565 is not for the cervical plate itself, but rather for instrumentation to facilitate implantation of the cervical plate. Specifically, it seeks to add two additional base material options and a surface treatment to these previously cleared instruments. The core cervical plate device, identified as the predicate, is K113170.

Therefore, the performance testing and acceptance criteria described in the document are focused on demonstrating that the changes to the instruments do not negatively impact safety and effectiveness, nor do they raise new questions. It does not describe a study proving the performance of the cervical plate itself, but rather the performance of the modified instruments.

Given this, I will answer the questions based on the information provided regarding the modified instrumentation.

Here's an analysis of the provided text:

A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a numerical or pass/fail threshold format for the performance tests. Instead, it states that testing was performed to "ensure" or "demonstrate" certain outcomes. The reported performance is a conclusion that these aims were met.

Acceptance Criteria Description (Implicit)	Reported Device Performance
Ensure that the addition of a surface treatment to previously cleared instruments does not negatively impact biocompatibility of the instruments.	"Biocompatibility Testing was performed to ensure that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact biocompatibility of the instruments." (Implies successful demonstration, i.e., no negative impact found).
Demonstrate that the coating provides additional wear resistance to the instruments.	"Additionally, ball on flat wear testing... was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration, i.e., coating provides additional wear resistance).
Demonstrate that the coating provides additional corrosion resistance to the instruments.	"Additionally, ... corrosion resistance testing was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration, i.e., coating provides additional corrosion resistance).
Demonstrate the effect of the surface treatment on the instruments' mechanical properties related to indentation.	"Additionally, ... instrumented indentation testing... was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration regarding the mechanical properties under indentation, likely linking to wear resistance, as the primary stated purpose of the coating is scratch resistance and hydrophobicity, and the performance testing aims to show additional wear/corrosion resistance.) The document does not state specific acceptance criteria values (e.g., "indentation depth less than X µm") nor does it provide quantitative results. It only states the testing was performed to demonstrate the effect.

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

The document does not specify the sample sizes used for the biocompatibility, wear, indentation, or corrosion resistance testing. It also does not provide information about the provenance of data (e.g., country of origin, retrospective or prospective). These types of tests are typically in vitro or in vivo (for biocompatibility) and not based on patient data provenance.
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)

This type of information (number and qualifications of experts for ground truth) is relevant to clinical studies involving human interpretation or pathology. Since the described tests are device performance tests related to materials science (biocompatibility, wear, corrosion, indentation) for surgical instruments, the concept of "ground truth" established by clinical experts for a "test set" in the context of diagnostic or interpretive performance does not apply here. The "ground truth" for these tests would be derived from validated testing methodologies and their results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Similar to point 3, adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus or tie-breaking mechanism is needed to establish a "ground truth" for comparison with an AI system. This concept is not applicable to the material and mechanical performance testing described in this document.
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. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices, often involving AI assistance, by comparing the performance of multiple human readers on multiple cases. The submission K190565 is for changes to surgical instruments (not a diagnostic device, and no AI component is mentioned). Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question relates to the performance of an AI algorithm in isolation. Since the device in question (modified surgical instruments) does not involve an AI algorithm, no standalone algorithm performance testing was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the material and mechanical tests (biocompatibility, wear, indentation, corrosion), the "ground truth" is established by the results of standardized and validated laboratory testing methods. This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather objective measurements and observations from controlled experiments. For biocompatibility, this usually involves in vitro (e.g., cytotoxicity) and/or in vivo (e.g., irritation, sensitization) tests against recognized standards (e.g., ISO 10993 series).
The sample size for the training set

The concept of a "training set" and "test set" is central to machine learning and AI development. Since this submission is for physical surgical instruments and does not involve AI, there is no training set in this context. The "tests" described are physical performance tests, not AI model evaluations.
How the ground truth for the training set was established

As there is no training set for an AI model, this question is not applicable.

Summary

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May 31, 2019

EiserTech, LLC % Dawn Norman Executive VP MRC-X, LLC 6075 Poplar Ave Memphis, Tennessee 38119

Re: K190565

Trade/Device Name: Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: February 22, 2019 Received: March 5, 2019

Dear Dawn Norman:

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

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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 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,

for CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K190565

Device Name Cervical Plate

Indications for Use (Describe)

-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies)

-Spondylolisthesis

-Fracture
-Spinal stenosis

-Tumors (primary and metastatic)

-Failed previous fusions

-Pseudoarthrosis

-Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

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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510(k) Summary

Cervical Plate February 22, 2019

Company:	Eistertech, LLC9988 Hibert Street Suite 302San Diego, CA 92131
EstablishmentRegistration:	3009381326
Primary Contact:	Dawn NormanPhone: 618-604-3064
Company Contact:	Lukas EisermannPhone: 888-262-2817
Trade Name:	Cervical Plate
Common Name:	Anterior Cervical Plate
Classification:	Class II
Regulation Number: 21 CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis
Panel:	87- Orthopedic
Product Code:	KWQ
Primary PredicateDevice:	Eisertech,LLC Cervical Plate (K113170)

Device Description:

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Indications for Use:

-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

Spondylolisthesis
Fracture
Spinal stenosis
Tumors (primary and metastatic)
Failed previous fusions
Pseudoarthrosis
Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

Substantial Equivalence:

The subject Cervical Plate components are substantially equivalent to the following Primary Predicate device:

Eisertech, LLC Cervical Plate: K113170

The subject components are similar to the predicate devices in terms of indications, geometry, and materials. Biocompatibility and wear testing have confirmed that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact the performance of the instruments. Thus, it can be concluded that the subject devices raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices.

Performance Testing:

Biocompatibility Testing was performed to ensure that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact biocompatibility of the instruments. Additionally, ball on flat wear testing, instrumented indentation testing, and corrosion resistance testing was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments.

Conclusion:

There are no substantial differences between the Cervical Plate and the predicate device with respect to intended use and technological characteristics, including basic design, base materials of manufacture, mechanical properties, and intended effect.

Therefore, the Cervical Plate can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.

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.