The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in one or two adjacent spinal levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

Device Description

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The previously cleared SABER-C interbody devices are offered manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers, as specified in ASTM F2026, ASTM F136, ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spikes or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
The subject submission seeks to expand size offerings and gain clearance for expanded indications and minor design modifications to the previously cleared devices.

AI/ML Overview

The provided text is a 510(k) clearance letter for the SABER-C System, an intervertebral body fusion device. It details the regulatory clearance, indications for use, device description, and a brief summary of performance testing.

However, the document does not contain information related to a study proving the device meets acceptance criteria specific to an AI/ML algorithm, nor does it specify any AI/ML components within the SABER-C System. The performance testing listed is entirely mechanical/physical bench testing for a physical implant (Axial Screw Pullout, Insertion Torque, plate pushoff), which is standard for orthopedic devices.

Therefore, it is not possible to complete the requested table and answer questions about AI/ML acceptance criteria, study design, sample sizes for AI, expert involvement for AI ground truth, MRMC studies, or standalone algorithm performance based on the provided text. The document is for a traditional medical device, not a software as a medical device (SaMD) or an AI-enabled device.

To address the prompt directly based on the provided text, the answer is that the document does not contain the information requested, as the device is a physical implant and not an AI/ML enabled medical device.

Summary of missing information directly related to AI/ML acceptance criteria and study:

No AI/ML Component: The document describes a physical interbody fusion device and its associated plates and screws. There is no mention of any AI or machine learning functionality.
Acceptance Criteria for AI/ML: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
Study Proving AI Compliance: There is no study described that would evaluate AI performance. The performance testing mentioned is purely mechanical (bench testing).
Sample Size (AI): Not applicable, as there's no AI component.
Data Provenance (AI): Not applicable.
Experts for Ground Truth (AI): Not applicable.
Adjudication Method (AI): Not applicable.
MRMC Study: Not applicable.
Standalone Performance (AI): Not applicable.
Type of Ground Truth (AI): Not applicable.
Training Set Sample Size (AI): Not applicable.
Training Set Ground Truth (AI): Not applicable.

If the prompt assumed an AI/ML component was present and requested how one would describe these aspects for a hypothetical AI/ML device in a similar FDA clearance, I would construct a general example. However, as the instruction is to describe "the study that proves the device meets the acceptance criteria" based on the input, and the input clearly does not describe an AI/ML device, the direct answer is that the information is not present.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 8, 2025

Elevation Spine, Inc.
℅ Ms. Christine Scifert
Partner
MRC Global, LLC
9085 East Mineral Circle
Suite 110
Centennial, Colorado 80112

Re: K250540
Trade/Device Name: SABER-C System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVE, KWQ, ODP
Dated: August 1, 2025
Received: August 1, 2025

Dear Ms. 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 (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.

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K250540 – Ms. Christine Scifert Page 2

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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250540 – Ms. Christine Scifert Page 3

assistance/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

Enclosure

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250540

Device Name
SABER-C 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)

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"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."

Page 5

510(k) Summary

SABER-C System

July 30, 2025

Company: Elevation Spine, Inc.
2511 Garden Rd, Suite B125
Monteray, CA 93940

Primary Contact: Christine Scifert – Partner
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial, CO 80112
Phone: (901) 831-8053
Email: christine.scifert@AskMRCGlobal.com

Company/Secondary Contact: Frank Larosa
Director of Project Management
Elevation Spine, Inc
Phone: 732-685-1422
flarosa@elevationspine.com

Trade Name: SABER-C System
Common Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Classification: Class II
Regulation: 21 CFR 888.3080 (Intervertebral Fusion Device With Integrated Fixation, Cervical)
Panel: Orthopedic
Product Code: OVE, KWQ, ODP
Primary Predicate: Elevation Spine SABER-C System – K190885

Device Description:

Page 205
K250540
Page 1 of 3

Page 6

The previously cleared SABER-C interbody devices are offered manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers, as specified in ASTM F2026, ASTM F136, ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spikes or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.

The subject submission seeks to expand size offerings and gain clearance for expanded indications and minor design modifications to the previously cleared devices.

Indications for Use:

Substantial Equivalence:

The subject Saber-C components are substantially equivalent to the following predicate devices:

Primary Predicate:
Elevation Spine SABER-C System (K190885)

Additional Predicates:
Globus Medical, Hedron IC (K191243)

K250540
Page 2 of 3

Page 7

The subject components are similar in indications to the predicate devices. Device sizing, geometry, and technological characteristics, and materials are similar to the predicate Hedron IC (K191243). Materials, manufacturing, sterilization, and packaging are identical to those of the primary predicate, Saber-C (K190885).

Performance Testing:

Performance Testing

The following bench performance testing has been conducted on the subject Saber-C System: Axial Screw Pullout and Insertion Torque per ASTM F543, and plate pushoff.

Conclusion:

Based on the performance analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

K250540
Page 3 of 3

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.