When used as a lumbar intervertebral body fusion device, the Republic Spine Restore Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Description

The Republic Spine Restore Intervertebral Body Fixation System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine lumbar intervertebral body fusion device, which may be implanted as a single device via an anterior, posterior, transforaminal or lateral approach.

The Republic Spine Restore Intervertebral Body Fusion System implant components are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560) to assist the surgeon with the proper placement of the device.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Republic Spine Restore Intervertebral Body Fusion System," which is a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish safety and efficacy from scratch.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for a novel device. Instead, it focuses on demonstrating that the new device is as safe and effective as existing predicate devices.

Here's how to interpret the available information according to your request categories:

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

The acceptance criteria for a 510(k) submission are generally that the device performs at least as well as (or is substantially equivalent to) the predicate device in relevant performance tests. The "reported device performance" are the results from these comparative tests.

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance (Worst-case PEEK device)
Static Axial Compression (ASTM F2077) performance is comparable to predicate.	Tested according to ASTM F2077. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate."
Dynamic Axial Compression (ASTM F2077) performance is comparable to predicate.	Tested according to ASTM F2077. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate."
Static Subsidence (ASTM F2267) performance is comparable to predicate.	Tested according to ASTM F2267. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate."
Static Expulsion performance is comparable to predicate.	Tested. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate."
Mechanical performance meets or exceeds requirements	An engineering analysis (FEA) was conducted to determine the worst-case size for testing, and this worst-case was tested. Conclusion: "Evaluation of the risks and performance data based on the differences between the subject device(s) and predicate(s) does not raise any new issues or concerns related to safety or effectiveness."
Biocompatibility	Manufactured from the same materials (titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560)) as predicate devices. Implicitly deemed acceptable due to material equivalence.

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

Sample Size for Mechanical Bench Tests: Not explicitly stated as a number of devices (e.g., N=5 per test). It mentions "the subject PEEK device is considered worst case and therefore, was utilized during design verification mechanical bench tests." This implies a representative number of units for each test type was used, as is standard for ASTM testing, but the exact count is not provided.
Data Provenance: The data is from bench testing conducted by the manufacturer, Republic Spine, LLC, to compare their device to predicate devices. This is not human data (no country of origin or retrospective/prospective designation applies).

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

This information is not applicable as this is a medical device 510(k) submission based on mechanical bench testing and substantial equivalence, not a study involving human subjects or expert image review. There is no concept of "ground truth" derived from expert consensus in this context.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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 information is not applicable. This is a physical medical device (intervertebral body fusion system), not an AI imaging or diagnostic algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" is defined by the standards and specifications (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the predicate devices. The device is considered to meet "ground truth" if its mechanical properties are comparable to or better than the predicate devices and meet the relevant ASTM standards for intervertebral body fusion devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning model. The mechanical tests are "verification" tests against standards and predicate performance.

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

This information is not applicable as there is no training set for this type of device submission.

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). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger font size than the rest of the text.

September 12, 2019

Republic Spine, LLC James Doulgeris Director of Business Development and Quality Systems 350 Camino Gardens Blvd Suite 103 Boca Raton, Florida 33432

Re: K190398

Trade/Device Name: Republic Spine Restore Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 17, 2019 Received: August 12, 2019

Dear Mr. Doulgeris:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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,

for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190398

Device Name

Republic Spine Restore Intervertebral Body Fusion 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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K190398: 510(K) Summary

Submitter's Name:	Republic Spine, LLC
Submitter's Address:	2424 N. Federal Hwy Suite 257Boca Raton, FL 33431
Submitter's Telephone:	561-362-8094
Contact Person:	James Doulgeris james@rspine.com
Date Summary was Prepared:	17 July 2019
Trade or Proprietary Name:	Republic Spine Restore Intervertebral BodyFusion System
Common or Usual Name:	Intervertebral Body Fusion System
Classification:	Class II per 21 CFR 888.3080
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices

Description of the Device Subject to Premarket Notification

Indications for Use

When used as a lumbar intervertebral body fusion device, Republic Spine Restore Intervertebral Body Fusion Spinal System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Technological Characteristics

The Republic Spine Restore Intervertebral Body Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

510k Number	Trade or Proprietary orModel Name	Manufacturer	Predicate Type
K090064	Intervertebral Body FusionSpinal System	Eminent Spine	Primary

Table 5-1 Predicate Devices

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K112664, K162206	Zavation IBF System	Zavation LLC	Reference
K190889	Republic Spine RestoreCervical Interbody FusionSystem	Republic Spine, LLC	Reference

Substantial Equivalence Conclusion

The basis of substantial equivalence of the subject device(s) and predicate device(s) is established on the following:

The subject device and the predicate devices have the following similarities:

Both systems have the same indications for use. The intended patient population and intended use are the same.
Both systems operate using the same fundamental scientific technology.
Both systems incorporate the same basic implant design.
Both systems use the same methods of sterilization.
Both systems use the same operational principles for the surgical implantation of the interbody cages.
Both systems are manufactured from the same materials.

The subject device and the predicate devices have the following differences:

Minor dimensional differences in height, width and depth. ●

Performance Data

The subject PEEK device is considered worst case and therefore, was utilized during design verification mechanical bench tests to address the design differences between the subject device(s) and the predicate device(s). An engineering analysis consisting of FEA was conducted to determine the worst-case size for testing. The worst case size for the subject device has been tested in the following test modes:

Static axial compression per ASTM F2077
. Dynamic axial compression per ASTM F2077
. Static subsidence per ASTM F2267
. Static expulsion

Conclusions: The results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate.

Conclusion

Evaluation of the risks and performance data based on the differences between the subject device(s) and predicate(s) does not raise any new issues or concerns related to safety or effectiveness. It is concluded that the subject device(s), is as safe and effective as the predicate device(s) for its intended use and is substantially equivalent to the legally marketed predicate device(s).

K190398: 510k Summary Page 2 of 2

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.