The Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Small VBR is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Small VBR is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Small VBR is optional.

Device Description

Small VBR™ is a system of corpectomy devices used to provide mechanical support to the cervical and thoracolumbar spine. Small VBR™ is a cylindrical implant with the capability for device expansion. The ends of the device incorporate a ring of teeth to engage the endplates of adjacent vertebrae. The device is offered non-sterile in various combinations of expansion range, angulation and footprint to accommodate patient anatomy.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "Small VBR™" (Vertebral Body Replacement). This document describes the device, its intended use, and its equivalence to legally marketed predicate devices, primarily through mechanical testing.

**Crucially, this document does not describe a study involving:

Acceptance criteria based on AI or diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
Human readers, radiologists, or expert consensus for ground truth establishment.
Training or test sets for an algorithm.
Multi-reader multi-case (MRMC) comparative effectiveness studies.**

Instead, the performance data section states: "Mechanical testing of the worst case Small VBR™ devices included static and dynamic compression and static and dynamic torsion following ASTM F2077. The mechanical test results demonstrate that Small VBR™ device performance is substantially equivalent to itself as a predicate device."

Therefore, based solely on the provided text, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or AI. The study described is a mechanical testing study for a spinal implant, comparing its physical performance to a predicate device.

Here's what I can extract based on the provided text about the mechanical testing:

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

Acceptance Criteria (based on ASTM F2077)	Reported Device Performance
Demonstrated static compression performance per ASTM F2077	Mechanical test results demonstrate substantial equivalence to predicate device.
Demonstrated dynamic compression performance per ASTM F2077	Mechanical test results demonstrate substantial equivalence to predicate device.
Demonstrated static torsion performance per ASTM F2077	Mechanical test results demonstrate substantial equivalence to predicate device.
Demonstrated dynamic torsion performance per ASTM F2077	Mechanical test results demonstrate substantial equivalence to predicate device.

Note: The specific numerical values for acceptance criteria or device performance are not provided in this document, only that they followed ASTM F2077 and demonstrated substantial equivalence.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated but implied to be "worst case Small VBR™ devices" for mechanical testing. For mechanical testing, this typically refers to a representative number of devices to ensure statistical validity, but the exact count isn't given.
Data Provenance: Not applicable in the context of patient data. The "data" refers to mechanical test results from the manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2077) and the physical properties of the device, not by expert human interpretation.

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

Not applicable. This is a mechanical engineering test, not a diagnostic study requiring human 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:

No, an MRMC study was not done. This device is a physical spinal implant, not an AI-powered diagnostic tool.

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

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

7. The type of ground truth used:

The ground truth is established by the ASTM F2077 standard for mechanical testing of spinal implants.

8. The sample size for the training set:

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

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

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

In summary, the provided document details the regulatory clearance of a physical medical device (spinal implant) based on mechanical testing demonstrating substantial equivalence, not a study evaluating diagnostic performance or AI.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

November 1, 2019

ulrich GmbH & Co. KG % Mr. Hans Stover President & CEO ulrich medical USA 18221 Edison Avenue Chesterfield, Missouri 63005

Re: K192117

Trade/Device Name: Small VBRTM Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MOP, PLR Dated: August 5, 2019 Received: August 6, 2019

Dear Mr. Stover:

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 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) K192117

Device Name Small VBR™

Indications for Use (Describe)

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) Summary

Image /page/3/Picture/2 description: The image shows the logo for Ulrich Medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized to include a black square to its left. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.

Date:	5 August 2019
Sponsor:	ulrich GmbH & Co. KG
	Buchbrunnenweg 12
	89081 Ulm
	Germany
	Phone: +49 (0) 731-9654-1304
	Fax: +49 (0) 731-9654-2802
Contact Person:	Hans Stover
	ulrich medical USA, Inc.
	18221 Edison Avenue
	Chesterfield, MO 63005
	(636) 519-0268 Office
	(636) 519-0271 Fax
Proposed Trade Name:	Small VBR™
Common Name:	Vertebral body replacement
Device Classification:	Class II
Classification Name:	Spinal intervertebral body fixation orthosis
Regulation:	21 CFR 888.3060
Device Product Code:	MQP, PLR
Purpose:	The aim of this submission is to request additional cervical spine indicationsfor the Small VBR™.
Device Description:	Small VBR™ is a system of corpectomy devices used to provide mechanicalsupport to the cervical and thoracolumbar spine. Small VBR™ is a cylindricalimplant with the capability for device expansion. The ends of the deviceincorporate a ring of teeth to engage the endplates of adjacent vertebrae.The device is offered non-sterile in various combinations of expansionrange, angulation and footprint to accommodate patient anatomy.
Intended Use:	The Small VBR is intended for use in skeletally mature patients in thecervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace acollapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis,trauma (i.e. fracture), or for reconstruction following corpectomy performedto achieve decompression of the spinal cord and neural tissues indegenerative disorders.The Small VBR is also intended to restore the integrity of the spinal columneven in the absence of fusion for a limited time period in patients withadvanced stage tumors involving the cervical, thoracic, and lumbar spine in
	whom life expectancy is of insufficient duration to permit achievement offusion, with bone graft used at the surgeon's discretion.The Small VBR is intended to be used with supplemental spinal fixationsystems cleared for use in the cervical, thoracic, and/or lumbar spine. Theuse of bone grafting material with the Small VBR is optional.
Materials:	Small VBR™ implants are manufactured from Ti-6Al-4V ELI titanium alloy(per ASTM F136).

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Primary Predicate:	Fortify® (Globus Medical Inc. – K173982)
Additional Predicates:	VBRTM (Osteotech Inc. – K012254), Rezaian Spinal Fixator (OrthopedicEquipment Co. Inc. - K841189)
Performance Data:	Mechanical testing of the worst case Small VBRTM devices included staticand dynamic compression and static and dynamic torsion following ASTMF2077.
	The mechanical test results demonstrate that Small VBRTM deviceperformance is substantially equivalent to itself as a predicate device.
TechnologicalCharacteristics:	The Small VBRTM possesses the same technological characteristics as oneor more of the predicate devices. These include:
	basic design (expanding corpectomy spacer), material (titanium alloy), sizes (dimensions are comparable to those offered by the predicate systems) and
	The fundamental scientific technology of the Small VBRTM is the same aspreviously cleared devices.
Conclusion:	The Small VBRTM possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore Small VBRTM issubstantially equivalent for its intended use.

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.