The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System 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 spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Device Description

The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy.

The RIGEL™ 3DR Anterior Cervical Corpectomy System consists of implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001 and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed and are intended for single use only.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the RIGEL™ 3DR Anterior Cervical Corpectomy System. It primarily focuses on the substantial equivalence of this medical device to previously cleared predicate devices.

It is crucial to understand that this document describes a medical device (an implant), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested points related to AI/SaMD performance criteria, expert adjudication, MRMC studies, and ground truth for training sets are not applicable.

Here's an analysis based on the provided text, highlighting the non-applicability of SaMD-specific questions:

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

The document does not explicitly state acceptance criteria in a quantitative table format as one would expect for an AI/SaMD. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance data presented are mechanical tests designed to show that the device meets established standards for spinal implants and performs comparably to its predicates.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance	- Static and dynamic compression testing (ASTM F2077-18) performed.
	- Static and dynamic torsion testing (ASTM F2077-18) performed.
	- Subsidence testing (ASTM F2267-04) performed.
Material Equivalence	Implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001. Instrumention from Stainless Steel per ASTM F899.
Design Equivalence	Same design features, geometries, and similar size range of footprints as predicate devices.
Performance Conclusion	Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Corpectomy System is substantially equivalent to legally marketed predicate systems.

2. 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 document describes mechanical testing of a physical implant, not a software device evaluated on a dataset. The "test set" in this context refers to the physical samples of the implant tested as per ASTM standards. The specific number of physical samples for each test (e.g., how many implants underwent compression testing) is not detailed. Data provenance such as country of origin or retrospective/prospective is not relevant for mechanical device 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. Ground truth, in the context of SaMD, refers to establishing the correct diagnosis or outcome from medical images/data, often by expert consensus. For a physical implant, "ground truth" is established by adherence to engineering specifications and performance against recognized ASTM standards. There are no medical experts establishing ground truth for the performance of the implant itself in this context, although clinical expertise guides the design and intended use.

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

This is not applicable for a physical device. Adjudication methods are used in SaMD studies to resolve discrepancies between expert readers on a test set to establish a definitive ground truth. For mechanical testing, the "adjudication" is inherent in the standardized test procedures and their objective measurements.

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 is not applicable. MRMC studies are specifically designed to evaluate the impact of AI on human reader performance. This document concerns a physical device, not an AI.

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

This is not applicable. A standalone performance evaluation refers to an AI algorithm making decisions without human intervention. This document is about a physical spinal implant.

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

As mentioned, the concept of "ground truth" as it applies to SaMD is not applicable here. For this physical device, the "truth" of its performance is derived from standardized mechanical testing (ASTM F2077-18 for static and dynamic compression/torsion, ASTM F2267-04 for subsidence). These tests provide objective, measurable data points against established industry standards for material strength, durability, and biocompatibility rather than a clinical ground truth.

8. The sample size for the training set

This is not applicable. Training sets are used to train AI algorithms. This document describes a physical medical device. While there's a design and development process for the implant, it doesn't involve "training" in the AI sense.

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

This is not applicable for the same reasons as above.

Summary

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October 13, 2023

Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway Suite 100 Marietta, Georgia 30062

Re: K232481

Trade/Device Name: RIGELTM 3DR Anterior Cervical Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: August 16, 2023 Received: August 16, 2023

Dear Mr. Bauman:

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) K232481

Device Name

RIGELTM 3DR Anterior Cervical Corpectomy System

Indications for Use (Describe)

The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System 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 spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

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

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

I. SUBMITTER	MiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607
II. OFFICIALCORRESPONDENT	Jordan BaumanVice President, Regulatory AffairsMiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607
III. DATE PREPARED	September 28, 2023
IV. DEVICEName of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type	RIGEL™ 3DR Anterior Cervical Corpectomy SystemSpinal Intervertebral Body Fixation Orthosis21 CFR 882.3060Class IIPLRTraditional 510(k)
V. PREDICATE DEVICE	Primary PredicateNEXXT MATRIXX® System - Nexxt Spine LLC (K193412)Additional PredicateC-VBR - Cardinal Spine, LLC (K152568)Reference DevicesRIGEL™ 3DR Anterior Cervical Interbody Fusion System -MiRus, LLC (K200685)NGage Surgical Mesh System - Blackstone Medical(K030744)

VI. DEVICE DESCRIPTION

The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy.

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Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed and are intended for single use only.

VII. INDICATIONS FOR USE

The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2- T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System 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 spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

VIII. PREDICATE DEVICE COMPARISON

IX. PERFORMANCE DATA

The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Corpectomy System was assessed through static and dynamic testing in accordance with the following test methods:

Static and dynamic compression testing (ASTM F2077-18)
Static and dynamic torsion testing (ASTM F2077-18)
Subsidence testing (ASTM F2267-04) ●

X. CONCLUSIONS

The RIGEL™ 3DR Anterior Cervical Corpectomy System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, and a similar size range of footprints. Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Corpectomy System is substantially equivalent to legally marketed predicate systems.

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.