The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the cervical spine (C2-T1), DOMINION spacers are in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Device Description

The Dominion Expandable Corpectomy system is a modular system comprised of Expandable Columns, Modular Endplates, and optional screws. The primary purpose of the Expandable Column is to provide mechanical support to the anterior column of the spine after a vertebral corpectomy is performed. The primary function of the Modular Endplates is to provide attachment points for the Expandable Column to the vertebral endplates. The screws are an optional device that can provide enhanced fixation to the vertebral endplates when desired. The system contains Inserters which allow the insertion and expansion of the Expandable Columns.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device (DOMINION Expandable Corpectomy System) and does not describe a study involving humans or AI for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document because it is not relevant to this type of device submission.

Here's a breakdown of what can be inferred from the document and why other points cannot be addressed:

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

The document lists several non-clinical tests that were performed, which inherently have acceptance criteria. However, the specific acceptance criteria values (e.g., minimum compression strength, maximum torsion deformation) and the reported device performance values (the actual measurements from the tests) are not detailed in this summary. It only states that the following analyses were conducted:

Acceptance Criteria (Implied)	Reported Device Performance (Not detailed in document)
ASTM F2077 - Static Compression Requirements	Results met or exceeded requirements (implied by substantial equivalence claim)
ASTM F2077 - Dynamic Compression Requirements	Results met or exceeded requirements (implied by substantial equivalence claim)
ASTM F2077 - Static Torsion Requirements	Results met or exceeded requirements (implied by substantial equivalence claim)
ASTM F2077 - Dynamic Torsion Requirements	Results met or exceeded requirements (implied by substantial equivalence claim)
Expulsion (Push-Out) Requirements	Results met or exceeded requirements (implied by substantial equivalence claim)
ASTM F2267 - Subsidence Requirements	Results met or exceeded requirements (implied by substantial equivalence claim)

The summary states, "Astura Medical considers the DOMINION Expandable Corpectomy Spacer to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." This implies that the non-clinical tests demonstrated performance comparable to or better than the predicate devices, thereby meeting relevant acceptance criteria established for such 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 provided in a 510(k) summary for non-clinical (mechanical) testing. Sample sizes for mechanical tests are typically dictated by testing standards (e.g., ASTM standards) rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable to mechanical performance testing.

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 is not applicable as the device is a spinal implant, and the "ground truth" for its performance is established through mechanical testing against engineering standards, not through expert human interpretation of medical images or patient data.

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

Not applicable. Mechanical test results are objective measurements and do not typically require adjudication by experts in the same way clinical or diagnostic studies do.

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

The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study was not done. This device is 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 not an AI algorithm.

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

For this medical device, the "ground truth" for its safety and effectiveness is established through the adherence to recognized international and national mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and the comparison of its performance to legally marketed predicate devices. It is based on engineering principles and material science, not clinical outcomes or expert consensus in a diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI system that requires a "training set."

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

Not applicable. As above, this device is not an AI system.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

March 8. 2024

Astura Medical Parker Kelch Quality Manager 4949 West Royal Ln Irving, Texas 75063

Re: K233359

Trade/Device Name: DOMINION Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: February 9, 2024 Received: February 9, 2024

Dear Parker Kelch:

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 OS 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,

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

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Indications for Use

510(k) Number (if known) K233359

Device Name DOMINION Expandable Corpectomy System

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: DOMINION Expandable Corpectomy System

Date Prepared	September 29, 2023
Submitted By	Astura Medical4949 W Royal LnIrving, TX 75063
Contact	Parker Kelch4949 W Royal LnIrving, TX 75063Phone: 469-501-5530 x503Email: parker@asturamedical.com
Trade Name	DOMINION Expandable Corpectomy System
Common Name	Expandable Corpectomy Spacer
Classification Name	Spinal Vertebral Body Replacement Device
Class	II
Product Code	MQP, PLR
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
Primary Predicate Device	ALTA Anterior Cervical Corpectomy Spacer (K190426)
Reference PredicateDevice(s)	DOLOMITE Anterior Cervical Stabilization System (K202065)FORTIFY Corpectomy Spacer (K173982)OLYMPIC Posterior Screw Fixation System (K153446)
Device Description	The Dominion Expandable Corpectomy system is a modular systemcomprised of Expandable Columns, Modular Endplates, and optionalscrews. The primary purpose of the Expandable Column is to providemechanical support to the anterior column of the spine after a vertebralcorpectomy is performed. The primary function of the Modular Endplatesis to provide attachment points for the Expandable Column to thevertebral endplates. The screws are an optional device that can provideenhanced fixation to the vertebral endplates when desired. The systemcontains Inserters which allow the insertion and expansion of theExpandable Columns.
Materials	Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136Nitinol #1 (ASTM F2063)
Technologicalcharacteristics	Compared to the ALTA corpectomy spacer, the Dominion has thecapability to expand to the desired height to suit patient anatomy. Onceexpanded its primary purpose of mechanical support to the anteriorcolumn of the spine is equivalent to that of the static ALTA corpectomyspacers.
Substantial EquivalenceClaimed to PredicateDevices	The DOMINION Expandable Corpectomy System is substantiallyequivalent to the predicate devices in terms of intended use, design,materials used, mechanical safety and performances.
Indications for Use	The DOMINION Expandable Corpectomy System is indicated for vertebralbody replacement in the cervical spine (C2-T1) and the thoracolumbarspine (T1-L5). The System is designed for use with autogenous and/orallogeneic bone graft comprised of cancellous and/or corticocancellousbone graft as an adjunct to fusion.
	When used in the cervical spine (C2-T1), DOMINION spacers are intendedfor use in skeletally mature patients to replace a diseased or damagedvertebral body caused by tumor fracture or osteomyelitis, or forreconstruction following corpectomy performed to achievedecompression of the spinal cord and neural tissues in the cervicaldegenerative disorders. These spacers are intended to restore theintegrity of the spinal column even in the absence of fusion for a limitedtime period in patients with advanced stage tumors involving the cervicalspine in whom life expectancy is of insufficient duration to permitachievement of fusion, with bone graft used at the surgeon's discretion.The System is intended to be used with supplemental fixation that hasbeen cleared by the FDA for use in the cervical spine.
	When used in the thoracolumbar spine (T1-L5), DOMINION spacers areintended for use to replace a collapsed, damaged, or unstable vertebralbody due to tumor or trauma (i.e. fracture). These spacers are designedto provide anterior spinal column support even in the absence of fusionfor a prolonged period.
	The system is intended to be used with supplemental fixation that hasbeen cleared by the FDA for use in the thoracolumbar spine (i.e. posteriorscrew and rod systems, anterior plate systems, and anterior screw androd systems). When used at more than two levels, supplemental fixationshould include posterior fixation.
Non-clinical TestSummary	The following analyses were conducted:ASTM F2077 - Static compression ASTM F2077 - Dynamic compression ASTM F2077 - Static Torsion ASTM F2077 - Dynamic Torsion Expulsion (Push-Out)
Clinical Test Summary	ASTM F2267 - Subsidence No clinical studies were performed
Conclusions: Non-Clinicaland Clinical	Astura Medical considers the DOMINION Expandable Corpectomy Spacerto be equivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation, technology,materials and indications for use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.