The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

Device Description

The MediExpand TL Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The columns can of the device can be adjusted to the exact length required by the patient's anatomy after implantation. Once it is adjusted to the desired length the columns are mechanically locked in place. The devices have a cylindrical space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "MediExpand TL Expandable VBR System." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.

The document primarily details the performance testing done according to ASTM F2077 to demonstrate that the device performs equivalently to the predicate devices, particularly under static and dynamic loading. This type of testing is mechanical, not clinical, and does not involve human readers, expert ground truth, or patient outcome data as would be found in a clinical study for AI performance validation.

Here's an assessment based on the available information:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail numerical thresholds for clinical performance in the provided text. The implicit acceptance criterion is "substantial equivalence" to predicate devices, supported by mechanical testing.
- Reported Device Performance: "Static and dynamic testing of the MediExpand TL Expandable VBR System was performed in accordance with ASTM F2077 as recommended by the FDA Guidance for Spinal System 510(k)'s." However, specific numerical results of this testing (e.g., load capacity, fatigue life) are not detailed in this summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable as the study described is mechanical testing, not a clinical study involving a test set of patient data.
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, as this is mechanical device testing, not a study requiring expert ground truth for interpretation of patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 medical implant, not an AI diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the mechanical testing would be the specified performance requirements of ASTM F2077 and the performance characteristics of the predicate devices. This involves engineering specifications and materials science data, not clinical ground truth.
The sample size for the training set:
- Not applicable.
How the ground truth for the training set was established:
- Not applicable.

Summary

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October 24, 2019

CMF Medicon Surgical Inc. % David Klementowski Sr. Consultant Regulatory Compliance Associates 102 Finwood Dr. Baldwinsville, New York 13027

Re: K190349

Trade/Device Name: MediExpand TL Expandable VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: September 17, 2019 Received: September 19, 2019

Dear Mr. Klementowski:

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

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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 (OS) 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 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,

Katherine D. Kavlock -S

for Ronald P. Jean, Ph.D. Director (Acting) 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)

K190349

Device Name

MediExpand TL Expandable VBR System

Indications for Use (Describe)

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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In accordance with Title 21 of the Code of the Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitter's Name and Address:	CMF MEDICON SURGICAL INC11200 St. Johns Industrial Pkwy N. Suite 1Jacksonville, FL 32246USA
Official Contact:	Matthias Alber
Contact Person and Telephone:	David Klementowski315-345-9514
Date Summary Prepared:	12/20/2018
Device Name:	Classification Name – Spinal IntervertebralBody Fixation Orthosis
	Common or Usual Name - Spinal VertebralBody Replacement Device
	Proprietary Name – MediExpand TLExpandable VBR System
Device Class:	Class II
Classification:	21 CFR § 888.3060
Product Code:	MQP
Predicate Devices
Primary Predicate Device:	Nuvasive X-Core Expandable VBR System(K142205)
Additional Predicate Device:	Aesculap HydroLift VBR System (K083186)

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Device Description:

Indication for Use:

Technological Characteristics:

As was established in this submission, the subject MediExpand TL Expandable VBR System is substantially equivalent to the other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent based on having the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function.

Performance Testing:

The MediExpand TL Expandable VBR System and the predicate devices Nuvasive X-Core Expandable VBR System and Aesculap HydroLift VBR System are similar in design, material, and indicated use, and are both cleared devices.

Static and dynamic testing of the MediExpand TL Expandable VBR System was performed in accordance with ASTM F2077 as recommended by the FDA Guidance for Spinal System 510(k)'s.

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Conclusion:

Based on the indication for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject MediExpand TL Expandable VBR System has been shown to be substantially equivalent to the legally marketed predicate devices.

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.