The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions with 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
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Spondylolisthesis
Spinal stenosis

Device Description

The ARENAL Anterior Cervical Plate System is interior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Arenal Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not contain information about a study proving device performance against acceptance criteria in the context of AI/software or human readers, as the device is a spinal implant.

Therefore, many of the requested categories are not applicable to the information provided.

However, I can extract information related to the performance of the device based on mechanical testing.

Here's the relevant information derived from the provided text for the mechanical testing of the device:

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

Test Type	Acceptance Criteria (from FDA Spinal Plating Systems guidance document)	Reported Device Performance (Arenal Anterior Cervical Plate System)
Static compression	Not explicitly stated, but implied as a numerical threshold in the guidance document.	Static Compression Bending Yield was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document.
Static compression	Not explicitly stated, but implied as a numerical threshold in the guidance document.	Static Compression Bending Stiffness was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document.
Dynamic compression	Not explicitly stated, but implied as a numerical threshold for runout load @ 5M cycles in the guidance document.	Dynamic Compression Bending Runout Load @ 5M cycles was in excess of the acceptance criteria listed in FDA Spinal Plating Systems guidance document. (This indicates better performance than criteria)
Static torsion	Not explicitly stated, but implied as a numerical threshold in the guidance document.	Static Torsion Yield was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document.
Static torsion	Not explicitly stated, but implied as a numerical threshold in the guidance document.	Static Torsion Stiffness was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document.

Study that proves the device meets the acceptance criteria:

The study referenced is a series of non-clinical mechanical tests performed according to ASTM standards for spinal implant constructs. These tests are:

Static compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Dynamic compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Static torsion per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

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: The document does not specify the sample size (number of devices tested) for each test.
Data Provenance: The tests were performed as part of the 510(k) submission process for a medical device (Arenal Anterior Cervical Plate System). The origin is not specified but is implicitly from testing conducted to support a US FDA submission. It is prospective testing, specifically designed to demonstrate safety and effectiveness for regulatory clearance.

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. The ground truth for mechanical testing is based on physical measurements and engineering principles, not expert interpretation.

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

Not applicable. Mechanical test results are quantitative and do not require adjudication.

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

Not applicable. This device is a physical spinal implant, not an AI or software-based diagnostic tool that would involve human readers.

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

Not applicable. This device is a physical spinal implant, not an AI algorithm.

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

The "ground truth" for these tests are the defined physical properties and performance characteristics as outlined in the ASTM F1717 standard and the FDA Spinal Plating Systems guidance document. This is based on engineering standards and regulatory requirements for spinal implants.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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May 17, 2024

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 & 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.

EffortMed, LLC % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven. Utah 84401

Re: K240935

Trade/Device Name: Arenal 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: April 3, 2024 Received: April 5, 2024

Dear J.D. Webb:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 FDA

Colin O'Neill, MBE Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

Device Name

Arenal 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)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Spondylolisthesis
Spinal stenosis

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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510(k) #: K240935	510(k) Summary		Prepared on: 2024-04-04
Contact Details			21 CFR 807.92(a)(1)
Applicant Name		EffortMed, LLC
Applicant Address	4766 NW 91st Way Coral Springs FL 33067 United States
Applicant Contact Telephone	917-566-3479
Applicant Contact	Mr. Steven Brown
Applicant Contact Email		sbrown@effortmed.com
Correspondent Name		The OrthoMedix Group, Inc.
Correspondent Address		4313 W. 3800 S. West Haven UT 84401 United States
Correspondent Contact Telephone		512-590-5810
Correspondent Contact		Mr. J.D. Webb
Correspondent Contact Email		jdwebb@orthomedix.net
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Arenal Anterior Cervical Plate System
Common Name		Spinal intervertebral body fixation orthosis
Classification Name		Appliance, Fixation, Spinal Intervertebral Body
Regulation Number		888.3060
Product Code(s)	KWQ
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)		Product Code
K162638	CETRA™ Anterior Cervical Plate System		KWQ
K211718	Venus Cervical Plate System		KWQ
Device Description Summary			21 CER 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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- Degenerative Disc Disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies) - Trauma (including fractures)

Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Spondylolisthesis
Spinal stenosis

Indications for Use Comparison

The Arenal Anterior Cervical Plate System has the same Indications for Use as the predicate.

Technological Comparison

Indications for Use: no difference Materials: no difference Design/geometry: similar Dimensions: similar Operating Principle: no difference Sterility: no difference There are no substantial differences between the Arenal Anterior Cervical Plate System and

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following tests were performed in determining substantial equivalence of the ARENAL Anterior Cervical Plate:

-Static compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

*Static Compression Bending Yield was in exceptance criteria listed in FDA Spinal Plating Systems quidance document. *Static Compression Bending Stiffness was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.

-Dynamic compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

*Dynamic Compression Bending Runout Load @ 5M cycles was in excess of the acceptance criteria listed in FDA Spinal Plating Systems quidance document.

-Static torsion per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a

Vertebrectomy Model

*Static Torsion Yield was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.

*Static Torsion Stiffness was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.

Not Applicable

The Arenal Anterior Cervical Plate System is substantially equivalent to the legally marketed device identified above.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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.