The Wolff's Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

• Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;

· Spondylolisthesis;
Spinal Stenosis:
· Trauma (including fractures);
· Tumor;
· Deformity (i.e., scoliosis, kyphosis, and/or lordosis);
· Pseudoarthrosis; and
· Failed previous fusions

Device Description

The Spinal Simplicity Wolff's Law Anterior Cervical Plate System is a dynamic cervical plate designed for the anterior cervical spine (C2-C7). The Wolff's Law Plate System consists of one-level plates in multiple lengths with both fixed- and variable-angle screws. The plates are translatable and use a nitinol Compression Element to provide continuous compression at each level. The Wolff's Law Cervical Plate consists of components made from titanium alloy Ti6Al4V ELI per ASTM F136 and superelastic nitinol per ASTM F2063. The fixed and variable screws are made from Titanium alloy Ti6Al4V ELI per ASTM F136. The Anterior Cervical Plate System is provided to the end-user sterile and is single use.

AI/ML Overview

The FDA 510(k) summary for the "Wolff's Law Anterior Cervical Plate System" describes non-clinical performance testing rather than a study involving an AI/CAD software device with specific acceptance criteria and human readers.

Therefore, I cannot provide information on the following as it is not present in the provided document:

A table of acceptance criteria and the reported device performance for an AI/CAD device.
Sample size used for the test set and data provenance.
Number of experts used to establish the ground truth and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
Standalone performance (algorithm only) of an AI/CAD device.
Type of ground truth used for an AI/CAD device.
Sample size for the training set.
How the ground truth for the training set was established.

However, based on the provided document, I can extract information related to the performance study of the Wolff's Law Anterior Cervical Plate System (a medical device, not an AI/CAD software):

1. Type of Study:
Non-clinical mechanical tests were performed to establish substantial equivalence for the Wolff's Law Anterior Cervical Plate System. Clinical performance testing was explicitly not performed for this submission.

2. Tests Performed and Guidance:
The study utilized FDA Guidance Document "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff" and the following ASTM tests:

ASTM F1717 Static Compression Bending
ASTM F1717 Static Torsion
ASTM F1717 Static Tension Bending
ASTM F1717 Dynamic Compression Bending
ASTM F543 Axial Screw Pullout/Pushout
ASTM F2129 & ASTM F3044 Corrosion Testing
ASTM F1877 Particulate Analysis
ASTM F2004 Transformational Temperature

3. Purpose of the Study:
The purpose of these non-clinical tests was to demonstrate that the Wolff's Law Anterior Cervical Plate System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device. The document explicitly states: "Performance testing device has mechanical performance substantially equivalent to that of the predicate."

4. Acceptance Criteria (Implied):
While not explicitly presented in a table in the provided text, the acceptance criteria for these mechanical tests are implicitly that the Wolff's Law Anterior Cervical Plate System must have mechanical performance substantially equivalent to the predicate device(s). This substantial equivalence is assessed against the standards outlined in the FDA Guidance Document and the specific ASTM standards listed. The document does not provide specific numerical thresholds or target values that define "substantial equivalence" in this summary.

5. Predicate Devices:
The predicate devices used for comparison are:

K083020 DynaTran™ Anterior Cervical Plating (ACP) System
K143626 SC-AcuFix® Ant-Cer Dynamic Cervical Plating System
K051665 Synthes Vectra-T System

In summary, the provided document details non-clinical mechanical testing for a spinal implant, not an AI/CAD system. Therefore, most of the requested information regarding AI/CAD specific acceptance criteria and study details are not applicable or available in this text.

Summary

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May 24, 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 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.

Spinal Simplicity LLC Adam Rogers Vice President of Regulatory and Engineering 6363 College Blvd Ste 320 Overland Park. Kansas 66211

Re: K240592

Trade/Device Name: Wolff's Law 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 1, 2024 Received: March 1, 2024

Dear Adam Rogers:

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 QS 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 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,

Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.05.24
13:52:10-04'00'
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

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Indications for Use

Submission Number (if known)

K240592

Device Name

Wolff's Law Anterior Cervical Plate System

Indications for Use (Describe)

• Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;

· Spondylolisthesis;
Spinal Stenosis:
· Trauma (including fractures);
· Tumor;
· Deformity (i.e., scoliosis, kyphosis, and/or lordosis);
· Pseudoarthrosis; and
· Failed previous fusions

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K240592 Page 1 of 2

Prepared on: 2024-05-21

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Spinal Simplicity LLC
Applicant Address	6363 College Blvd Ste 320 Overland Park KS 66211 United States
Applicant Contact Telephone	913-451-4414
Applicant Contact	Mr. Adam Rogers
Applicant Contact Email	arogers@spinalsimplicity.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Wolff's Law 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
K083020	DynaTran™ Anterior Cervical Plating (ACP) System	KWQ
K143626	SC-AcuFix® Ant-Cer Dynamic Cervical Plating System	KWQ

Device Description Summary

Synthes Vectra-T System

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

KWQ

21 CFR 807.92(a)(4)

The Wolff's Law Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

• Degenerative Disc Disease (DDD) – as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies;

• Spondylolisthesis;

• Spinal Stenosis;

K051665

· Trauma (including fractures);

· Tumor;

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

• Pseudoarthrosis; and

• Failed previous fusions

Indications for Use Comparison

The indications for use of the primary and secondary predicate devices fully encompasses the Wolff's Law Anterior Cervical Plate System indication for use statement. The types of conditions for which the Wolff's Law Anterior Cervical Plate System is used are identical to the predicate devices. The slight differences in the indications for use statements do not constitute a new intended use.

Technological Comparison

The Wolff's Law Anterior Cervical Plate System has similar technological characteristics, surgical approach, materials, range of sizes, design and principles of operation as the predicate devices. Any differences in technological characteristics do not raise different questions of safety or effectiveness. Performance testing device has mechanical performance substantially equivalent to that of the predicate.

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

Non clinical mechanical tests were performed to substantial equivalence of the Wolffs Law Anterior Cervical Plate System. Custom test were also performed to support the performance and substantial equivalence of the device. FDA Guidance Document Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Druq Administration Staff was used to support the performance testing and the following ASTM test were performed:

ASTM F1717 Static Compression Bending ASTM F1717 Static Torsion ASTM F1717 Static Tension Bending ASTM F1717 Dynamic Compression Bending ASTM F543 Axial Screw Pullout/Pushout ASTM F2129 & ASTM F3044 Corrosion Testing ASTM F1877 Particulate Analysis ASTM F2004 Transformational Temperature

Clinical performance testing was not performed for this submission.

Spinal Simplicity concludes that the performance testing provided in this 510(k) application demonstrates that the Wolffs Law Anterior Cervical Plate System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device.

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.