The MONDRIAN Lumbar Plate System is indicated as additional support during fusion in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Description

The MONDRIAN Anterior Lumbar Plate System is anterior lumbar fusion devices used to provide structural stability in skeletally mature individuals. The system consists of plates, screws, and instruments to facilitate the installation of the implants. Plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

AI/ML Overview

Based on the provided FDA 510(k) Clearance Letter for the MONDRIAN™ Anterior Lumbar Plate System, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics. It is not a detailed study report for a novel medical device, especially an AI-powered one. Therefore, many of the requested items related to AI device performance evaluation (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable or present in this type of document because the device in question is a physical surgical implant, not an AI/software device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical Performance	Demonstrated through non-clinical bench testing for:
- Static Compression Bending	Results indicate performance suitable for intended use.
- Dynamic Compression Bending	Results indicate performance suitable for intended use.
- Static Torsion	Results indicate performance suitable for intended use.
- Dynamic Torsion	Results indicate performance suitable for intended use.
- Static Compression Shear	Results indicate performance suitable for intended use.
- Dynamic Compression Shear	Results indicate performance suitable for intended use.
- Subsidence	Results indicate performance suitable for intended use.
Biocompatibility	Implied by use of ASTM F136 Titanium Alloy and ASTM F899 Stainless Steel, common in orthopedic implants.
Sterilization	User-required steam sterilization, similar to predicate devices.

Explanation: The "acceptance criteria" for a physical implant device like the MONDRIAN™ Anterior Lumbar Plate System are primarily related to its mechanical strength, durability, material safety (biocompatibility), and functionality under simulated physiological loads. The reported device performance is that the non-clinical tests showed the device meets these requirements and performs within its intended uses, indicating no new safety or effectiveness concerns compared to the predicate device. Specific numerical acceptance thresholds are not detailed in this high-level summary but would be part of the full submission.

Study Details (Focusing on the provided document's context)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "sample size" in the context of clinical data or AI test sets, as this is a non-clinical bench testing submission for a physical implant. The "test set" for this device refers to the number of implants or test specimens subjected to the various mechanical tests. This information is typically found in the test reports themselves, not the 510(k) summary.
- Data Provenance: Not applicable in the context of country of origin for clinical data, as no clinical studies were performed ("Clinical Tests: N/A"). The non-clinical tests would have been performed in a laboratory setting, likely within the manufacturing entity's or a contract testing facility's country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This question typically pertains to studies involving human interpretation (e.g., radiologists, pathologists) to establish ground truth for AI algorithms. For a physical implant, "ground truth" is established by engineering specifications, material standards, and validated mechanical testing methodologies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to resolve disagreements among human experts in establishing ground truth for clinical studies or AI performance evaluation. For mechanical testing, results are objective measurements against predefined engineering criteria, eliminating the need for adjudication.
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 not relevant here as the MONDRIAN™ Anterior Lumbar Plate System is a physical surgical implant, not an AI software device intended to assist human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This refers to the performance of an AI algorithm alone. The MONDRIAN™ Anterior Lumbar Plate System is a physical medical device; thus, this type of standalone performance evaluation is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Material Standards: For this device, the "ground truth" for evaluating its performance comes from established engineering principles, material science (e.g., ASTM F136 and ASTM F899 standards for Titanium Alloy and Stainless Steel), and validated mechanical testing protocols. The device's ability to withstand specified loads (static and dynamic) without failure or excessive deformation, and its material compliance, constitute the 'ground truth' it must meet.
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of machine learning or AI for this physical medical device.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this physical device, the concept of establishing ground truth for it does not apply.

In summary, the provided document details the 510(k) clearance for a physical implant device. The "study" proving it meets acceptance criteria consists of non-clinical mechanical bench testing demonstrating its equivalence in performance and characteristics to legally marketed predicate devices, rather than clinical trials or AI performance evaluations.

Summary

FDA 510(k) Clearance Letter - MONDRIAN™ Anterior Lumbar Plate System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.06.07
Silver Spring, MD 20993
www.fda.gov

January 26, 2024

CTL Medical Corporation
℅ Dhaval Saraiya
Regulatory Affairs and Quality Assurance Consultant
Omnee Strategic Solutions, Inc.
7 Desrosiers Landing
South Grafton, Massachusetts 01560

Re: K231715
Trade/Device Name: MONDRIAN™ Anterior Lumbar Plate System
Regulation Number: 21 CFR 888.3060
Regulation Name: Appliance, Fixation, Spinal Intervertebral Body
Regulatory Class: Class II
Product Code: KWQ
Dated: December 28, 2023
Received: December 29, 2023

Dear Dhaval Saraiya:

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).

Page 2

K231715 - Dhaval Saraiya Page 2

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 (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

Brent Showalter -S

Brent Showalter, Ph.D.
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

Page 3

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K231715

Device Name
MONDRIAN™ Anterior Lumbar Plate System

Indications for Use (Describe)
The MONDRIAN Lumbar Plate System is indicated as additional support during fusion in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K231715 - Page 1 of 1

Page 4

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the MONDRIAN Anterior Lumbar Plate System 510(k) premarket notification.

Sponsor: CTL Medical Corporation
Sean Suh
4550 Excel Pkwy
Ste 300
Addison, TX 75001

Contact Person: Dhaval S.
Omnee Strategic Solutions, Inc.
Regulatory/Quality Consultant
Email: omneestrategicsol@gmail.com

Date: Jan 25, 2024

Trade Name: MONDRIAN™ Anterior Lumbar Plate System
Common Name: Spinal Intervertebral Body Fixation Orthosis
Classification Name: KWQ – Appliance, Fixation, Spinal Intervertebral Body (21 CFR 888.3060)

Predicate Device(s):

Type	K Number	Device Name	Manufacturer
Primary Predicate	K213641	MONDRIAN ALIF Cage with Supplementary Fixation Plate System	CTL Medical
Additional Predicate	K173885	Genesys Spine Binary Lumbar Plate System	Genesys Spine
Additional Predicate	K131981	CEZANNE II Interbody Fusion System	CTL Medical

Purpose and Device Description:

The purpose of this submission is to request clearance for the new MONDRIAN Anterior Lumbar Plate System. The MONDRIAN Anterior Lumbar Plate System is anterior lumbar fusion devices used to provide structural stability in skeletally mature individuals. The system consists of plates, screws, and instruments to facilitate the installation of the implants. Plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

K231715 - Page 1 of 2

Page 5

Intended Use and Indications for Use:

Summary of Technological Characteristics:

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

Intended Use: The intended use is similar to the intended use cleared in K173885.
Indications for Use: The indications for use are similar to the indications for use cleared in K173885.
Materials: The MONDRIAN Anterior Lumbar Plate System implants are manufactured from Titanium Alloy per ASTM F136 and instruments are manufactured from Stainless Steel per ASTM F899 which are commonly used materials in orthopedic implants and instruments and similar to materials used in the identified predicate devices.
Design Features: The design features for the MONDRIAN Anterior Lumbar Plate System implants and instruments are identical to those in currently marketed devices cleared in K213641. There are no design differences between the subject device and the devices cleared under K213641.
Sterilization: The MONDRIAN Anterior Lumbar Plate System implants and instruments are offered to the user in the non‐sterile configuration. The non‐sterile implants and instruments will be required to be steam sterilized by the user prior to use, similar to the devices cleared in the identified predicate devices.

Summary of Performance Data (Nonclinical and/or Clinical):

Non-Clinical Tests:
- Static Compression Bending
- Dynamic Compression Bending
- Static Torsion
- Dynamic Torsion
- Static Compression Shear
- Dynamic Compression Shear
- Subsidence
Clinical Tests:
- N/A

Substantial Equivalence

The MONDRIAN Anterior Lumbar Plate System has been shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.

K231715 - Page 2 of 2

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.