The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.

Device Description

The Solidity™ Vertebral Body Replacement is a system of corpectomy devices used to provide mechanical support to the thoracolumbar spine. The Solidity™ Vertebral Body Replacement components include a cylindrical center piece and end caps. The center piece provides the capability for device expansion. End caps provide the anatomical footprint for the device. The components are offered in expansions, angle, footprint combinations to accommodate varying patient anatomy.

AI/ML Overview

This document is a 510(k) summary for the Solidity™ Vertebral Body Replacement device, which is a medical device for spinal intervertebral body fixation. This type of device does not typically involve AI/ML components, and therefore the concepts of "acceptance criteria for device performance" in the context of AI models, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set size," and "ground truth establishment for training set" are not applicable to the information provided in this document.

The document discusses the regulatory compliance and mechanical performance of the device, which are different types of acceptance criteria than those for AI/ML performance.

Here's an analysis of the provided text based on the request, reinterpreting "acceptance criteria" and "device performance" in the context of a non-AI medical device:

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

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Device must meet established biomechanical standards for spinal implants (e.g., ASTM F2077 for static and dynamic compression, and static and dynamic torsion).	"Mechanical testing of worst case Solidity™ devices included static and dynamic compression, and static and dynamic torsion according to ASTM F2077. In addition, the expulsion properties were evaluated. The mechanical test results demonstrate that Solidity™ performance is substantially equivalent to the predicate devices."
Material Composition	Device components must be manufactured from biocompatible and appropriate materials for implantation (e.g., medical-grade titanium alloy).	"Solidity™ components are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136)." This implicitly meets the standard for this material.
Substantial Equivalence	Device must demonstrate substantial equivalence in intended use and technological characteristics to legally marketed predicate devices, meaning it is as safe and effective as the predicate.	"The Solidity™ Vertebral Body Replacement possesses the same intended use and technological characteristics as the predicate devices. Therefore Solidity™ is substantially equivalent for its intended use."
Intended Use	Device must clearly define its indications for use and demonstrate suitability for those indications.	"The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional."
Basic Design	Device must have a design that is consistent with existing cleared devices for similar purposes (e.g., expanding corpectomy spacer).	The device has the "basic design (expanding corpectomy spacer)" which is the same as one or more predicate devices.
Sizes/Dimensions	Device must offer sizes and dimensions comparable to predicate systems to accommodate varying patient anatomy.	"sizes (dimensions are comparable to those offered by the predicate systems)"
Fundamental Scientific Technology	Device must use fundamental scientific technology that is the same as previously cleared devices.	"The fundamental scientific technology of the Solidity™ is the same as previously cleared devices."

2. Sample size 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 this is not an AI/ML device study. The provided document details mechanical testing of physical devices. The "test set" here refers to the actual physical devices subjected to mechanical tests. The document does not specify a "sample size" in terms of number of devices tested, other than referring to "worst case Solidity™ devices." Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.

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)

This information is not applicable. For mechanical testing of a medical device, "ground truth" is established by physical measurement against engineering standards (like ASTM F2077), not by expert consensus on data interpretation.

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

This information is not applicable. Adjudication methods are relevant for subjective data interpretation, which is not the case for mechanical testing of a physical device.

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

This information is not applicable. This is a physical medical device, not an AI/ML system. Therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

The "ground truth" for the device's mechanical performance is based on established engineering standards and material specifications (e.g., ASTM F2077 for mechanical properties, ASTM F136 for material composition). For substantial equivalence, the "ground truth" refers to the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

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

This information is not applicable. There is no "training set" for this type of device.

Summary

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November 16, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

ulrich medical USA Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005

Re: K181921

Trade/Device Name: Solidity™ Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: September 21, 2018 Received: September 24, 2018

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 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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181921

Device Name Solidity™ Vertebral Body Replacement

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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 appear as if it is emerging from a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.

Date:	16 July 2018
Sponsor:	ulrich medical USA, Inc.
	18221 Edison Avenue
	Chesterfield, MO 63005
	(636) 519-0268 Office
	(636) 519-0271 Fax
Contact Person:	Hans Stover, President & CEO
Proposed Trade Name:	Solidity™ Vertebral Body Replacement
Common Name:	Vertebral body replacement
Device Classification:	Class II
Classification Name:	Spinal vertebral body replacement device
Regulation:	888.3060
Device Product Code:	MQP
Device Description:	The Solidity™ Vertebral Body Replacement is a system of corpectomydevices used to provide mechanical support to the thoracolumbar spine.The Solidity™ Vertebral Body Replacement components include acylindrical center piece and end caps. The center piece provides thecapability for device expansion. End caps provide the anatomical footprintfor the device. The components are offered in expansions, angle, footprintcombinations to accommodate varying patient anatomy.
Intended Use:	The Solidity™ Vertebral Body Replacement is intended for use during opensurgical procedures in the thoracic and lumbar spine (T1-L5) to replace acollapsed, damaged, or unstable vertebral body due to tumor or trauma(e.g., fracture).The Solidity™ is intended to be used with supplemental spinal fixation. Theuse of bone grafting material with the Solidity™ is optional.
Materials:	Solidity™ components are manufactured from Ti-6Al-4V ELI titanium alloy(ASTM F136).
Predicate Devices:	Primary: VBR™ (Osteotech Inc. – K012254)Additional: VBR™ (Osteotech Inc. – K003155), Hawkeye™ VBR System(Choice Spine LP – K171686), Surgical Titanium Mesh™ System (DePuyAcroMed, K003043), Rezaian Spinal Fixator (Orthopedic Equipment Co.Inc. - K841189)
Performance Data:	Mechanical testing of worst case Solidity™ devices included static anddynamic compression, and static and dynamic torsion according to ASTMF2077. In addition, the expulsion properties were evaluated.The mechanical test results demonstrate that Solidity™ performance issubstantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The Solidity™ Vertebral Body Replacement possesses the sametechnological characteristics as one or more of the predicate devices. Theseinclude: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 Solidity™ is the same as previously cleared devices.
Conclusion:	The Solidity™ Vertebral Body Replacement possesses the same intended use and technological characteristics as the predicate devices. Therefore Solidity™ is substantially equivalent for its intended use.

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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.