The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

Device Description

The Stable-L Interbody System is a stand-alone lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided nonsterile and are expected to be sterilized by the end-user prior to use.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0 , 6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.

The purpose of this Special 510(k) submission is to gain clearance for the subject devices to be provided sterile via gamma radiation.

AI/ML Overview

The provided text is a 510(k) summary for the Nexus Spine Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System. It states that the purpose of the Special 510(k) submission is to gain clearance for these devices to be provided sterile via gamma radiation, whereas the predicate devices were provided non-sterile. The document explicitly states:

"The subject components are identical in indications, sizing and geometry, technological characteristics, and materials to the predicates. The only difference between the subject device and predicate device is that the subject device is provided sterile via gamma radiation and the predicate device is provided nonsterile. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness."

And under "Performance Testing":

"There is no change to the intended use, indication for use, materials, geometry, or dimensions to the Stable-L Standalone Lumbar Interbody System or Stable-C Interbody System. There is no mechanical performance testing included in this submission. Sterilization validation, packaging validations, and shelf life validation have all been performed to support the gamma radiation sterilization change."

Based on this, the acceptance criteria and study proving the device meets the acceptance criteria are not related to the clinical performance or diagnostic accuracy of an AI/ML-driven device, but rather to the sterility and packaging integrity of a medical implant after a change in sterilization method.

Therefore, I cannot provide the information requested in points 1-9 of your prompt, as it pertains to AI/ML device validation (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.). This document describes a medical device, but its 510(k) submission focuses on a sterilization method change, not an AI/ML component.

If you are looking for an example of an AI/ML device clearance document, this specific text will not provide the details you're seeking regarding AI/ML acceptance criteria and performance studies.

Summary

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September 18, 2023

Image /page/0/Picture/1 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Nexus Spine, LLC % Christine Scifert Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial. Colorado 80112

Re: K232530

Trade/Device Name: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD. OVE Dated: August 18, 2023 Received: August 21, 2023

Dear Christine Scifert:

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,

Katherine D. Kavlock -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known)

K232530

Device Name Stable-L Standalone Lumbar Interbody 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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Indications for Use

510(k) Number (if known)

K232530

Device Name Stable-C Interbody System

Indications for Use (Describe)

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in sketally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a standalone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System August 31, 2023

Company:	Nexus Spine, LLC2825 East Cottonwood Parkway Suite 330Salt Lake City, UT 84121
Primary/Secondary Contact:	Christine Scifert – PartnerMRC Global9085 E. Mineral Cir., Suite 110Centennial, CO 80112Phone: (901) 831-8053Email: christine.scifert@AskMRCGlobal.com
	Jen McBride - Regulatory Consultant(901) 481-5902Email: jen.mcbride@askmcrglobal.com
Company Contact:	Jared CrockerVice President of Quality and Regulatory AffairsNexus Spine, LLCPhone: (801) 702-8592jared.crocker@nexusortho.com
Trade Name:	Stable-L Standalone Lumbar Interbody SystemStable-C Interbody System
Common Name:Classification:	Intervertebral Fusion Device With Integrated Fixation, LumbarIntervertebral Fusion Device With Integrated Fixation, CervicalClass II
Regulation:	21 CFR 888.3080 (Intervertebral Fusion Device With IntegratedFixation, Lumbar; Intervertebral Fusion Device With IntegratedFixation, Cervical)
Panel:	Orthopedic
Product Code:	OVD, OVE
Primary Predicate:	Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System -K212498

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Device Description:

The purpose of this Special 510(k) submission is to gain clearance for the subject devices to be provided sterile via gamma radiation.

Indications for Use:

Substantial Equivalence:

The subject Nexus Spine Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System are substantially equivalent to the legally marketed predicate devices:

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Primary Predicate:

Nexus Spine, LLC, Stable-L Standalone Lumbar Interbody System -K212498

Secondary Predicate:

Nexus Spine, LLC, Stable-C Interbody System - K231763
The subject components are identical in indications, sizing and geometry, technological characteristics, and materials to the predicates. The only difference between the subject device and predicate device is that the subject device is provided sterile via gamma radiation and the predicate device is provided nonsterile. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

Performance Testing:

The is no change to the intended use, indication for use, materials, geometry, or dimensions to the Stable-L Stnadalone Lumbar Interbody System or Stable-C Interbody System. There is no mechanical performance testing included in this submission. Sterilization validation, packaging validations, and shelf life validation have all been performed to support the gamma radiation sterilization change.

Conclusion:

The subject device is determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.