The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Device Description

The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile.

AI/ML Overview

The provided FDA 510(k) summary is for a medical device called the "Cervical Stand-Alone System," which is an anterior cervical interbody fusion system. This documentation primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than presenting a clinical study with detailed acceptance criteria for an AI/software device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance for an algorithm) are not applicable to this type of device and submission. This is a physical implant, not an AI or software-based medical device.

However, I can extract the relevant "acceptance criteria" (which in this context refers to the performance standards the physical device must meet) and the "study" that proves it.

Here's the information based on the provided text, with clarifications where the questions are not relevant to this type of device:

Device Name: Cervical Stand-Alone System

Device Type: Intervertebral Body Fusion Device (physical implant)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary does not explicitly state numerical "acceptance criteria" values prior to presenting the results. Instead, it states that the device was tested per specific ASTM standards. The "reported device performance" is summarized as the device being "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices" based on these tests. The specific numerical results are not provided in this summary document.

Acceptance Criteria (Implicitly, meeting ASTM F2077 and F2267 standards and demonstrating substantial equivalence to predicates)	Reported Device Performance
Mechanical Performance:
Static axial compression (per ASTM F2077)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Dynamic axial compression (per ASTM F2077)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Static compression shear (per ASTM F2077)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Dynamic compression shear (per ASTM F2077)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Static torsion (per ASTM F2077)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Dynamic torsion (per ASTM F2077)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Subsidence (per ASTM F2267)	Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices.
Overall Conclusion:	The Cervical Stand-Alone System is substantially equivalent to the predicate device based on overall technology characteristics and mechanical performance data.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the document. This would refer to the number of physical devices or test specimens used in the mechanical tests. For mechanical testing of implants, sample sizes are typically small, determined by statistical requirements for engineering studies.
Data Provenance: The data is from non-clinical mechanical testing conducted on the device itself. It is not patient data, nor is there a concept of "country of origin" as it relates to clinical data. The tests were performed to ASTM (American Society for Testing and Materials) standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device subject to mechanical engineering tests, not a diagnostic or AI device requiring expert ground truth for interpretation of clinical conditions. The "ground truth" for these tests would be the physical properties and failure points measured by specialized testing equipment.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in clinical studies or for establishing ground truth in diagnostic AI performance evaluation. This document describes mechanical device testing.

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

Not applicable. This is a physical medical implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Not applicable. This question pertains to AI algorithms. The Cervical Stand-Alone System is a manufactured physical implant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering measurements against specified ASTM (American Society for Testing and Materials) standards. This involves measuring force, displacement, and cycles to failure under various loading conditions. It is not expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy, but rather the physical and mechanical integrity of the implant.

8. The sample size for the training set

Not applicable. This refers to training data for an algorithm. This device is a physical product, not an algorithm.

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

Not applicable. This refers to establishing ground truth for algorithmic training data.

Summary

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November 5, 2021

Eminent Spine, LLC % Meredith May, MS, RAC Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K212853

Trade/Device Name: Cervical Stand-Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 3, 2021 Received: September 7, 2021

Dear Meredith May:

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,

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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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 on last page.

510(k) Number (if known)

K212853

Device Name

Cervical Stand-Alone System

Indications for Use (Describe)

The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Type of Use (Select one or both, as applicable) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) ∑ Prescription Use (Part 21 CFR 801 Subpart D) 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: 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."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

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510(K) SUMMARY

Submitter's Name:	Eminent Spine, LLC
Submitter's Address:	2004 Ventura Drive, Suite 100Plano, Texas 75093
Submitter's Telephone:	972-499-3593
Contact Person:	Meredith May MS, RACEmpirical Testing Corp.1-719-337-7579MMay@EmpiricalTech.comImage: Empirical Testing Corp. Logo
Date Summary was Prepared:	September 3, 2021
Trade or Proprietary Name:	Cervical Stand-Alone System
Common or Usual Name:	Intervertebral Fusion Device With Integrated Fixation, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

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The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use
Materials of manufacture
. Structural support mechanism
Sizes ●

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	ProductCode	PredicateType
K200115,K173077	Cavetto®-SA Cervical Cage System	NeuroStructures,Inc.	OVE	Primary
K200087	F3D Cervical Stand-Alone InterbodyFusion System	CoreLink, LLC	OVE	Additional
K132029	Vault-C Standalone Cervical InterbodyFusion System	Spinal USA, Inc.	OVE	Additional
K131880	SpineFrontier® A-CIFT™ SoloFuse™Cervical Intervertebral Body FusionDevice	SpineFrontier,Inc.	OVE	Additional

PERFORMANCE DATA

The Cervical Stand-Alone System has been tested in the following test modes:

Static and dynamic axial compression per ASTM F2077 ●
Static and dynamic compression shear per ASTM F2077 ●
Static and dynamic torsion per ASTM F2077 ●
. Subsidence per ASTM F2267

The results of this non-clinical testing show that the strength of the Cervical Stand-Alone System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cervical Stand-Alone System is substantially equivalent to the predicate device.

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.