The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Device Description

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.

AI/ML Overview

The provided document is a 510(k) summary for the Reliance Lumbar IBF System, which is an intervertebral body fusion device. This type of regulatory submission usually does not include detailed studies on software performance or AI algorithms, as it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, intended use, and mechanical/performance testing for the physical device itself.

Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly pertaining to AI or software performance, is not present in this document. The document describes non-clinical testing for the physical implant components, specifically Finite Element Analysis to assess the effect of new sizes on structural properties, and sterilization validation.

Here's a breakdown of why the requested information cannot be provided from this document:

A table of acceptance criteria and the reported device performance: This document only states that "Finite Element Analysis has been carried out to access the effect of new sizes on the structural properties of the implant. Test results show the new components are not the new worst case when compared to the approved Reliance Lumbar IBF PEEK, 1-04-XXX, per K113540." It does not provide specific acceptance criteria or quantitative performance data from this analysis.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned, as the testing described is primarily mechanical/structural analysis, not software validation on clinical data.
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): Not applicable, as this is not a study involving expert-derived ground truth for software or AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of testing described.
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 document is for a physical medical implant, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component described.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for the type of testing described (mechanical testing).
The sample size for the training set: Not applicable. No AI training is described.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission relates to a physical intervertebral body fusion device and not a software or AI-powered medical device. Therefore, the detailed information about AI-related acceptance criteria, studies, and data provenance is not relevant to this document and is not present.

Summary

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Reliance Medical Systems LLC Bret Berry Member-Manager 545 West 500 South, Suite 100 Bountiful, Utah 84010

Re: K183049

Trade/Device Name: Reliance Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 16, 2019 Received: January 18, 2019

Dear Mr. Berry:

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

February 15, 2019

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183049

Device Name Reliance Lumbar IBF System

Indications for Use (Describe)

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Type of Use (Select one or both, as applicable)
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|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Bret M. Berry Reliance Medical Systems 545 West 500 South Suite 100 Bountiful, UT 84010 801-388-0700 Telephone: Fax: 801-294-0079

Bret M. Berry Contact: Member-Manager

Common or Usual Name:	Intervertebral Body Fusion Device
Proposed Proprietary or Trade Name:	Reliance Lumbar IBF System
Classification Name:	Class II, Intervertebral Body Fusion Device
	21 CFR 888.3080
Product Code:	MAX
Date:	02/15/2019

Substantial Equivalence

The Reliance Lumbar IBF is substantially equivalent to the legally marketed, primary predicate device. Reliance Lumbar IBF System (K180687). The subject Relianace Lumabr IBF System is also substantially equivalent to the additional predicate devices, Reliance Lumbar IBF System (K113540. K160463, and K173283). Subject devices differ in terms of additional size configurations.

The Reliance Lumbar IBF is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

Device Description

Intended Use/Indications for Use

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K183049 Page 2 of 2

spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Non-Clinical Testing

The subject implants does not create a new worst case condition for mechanical testing or performance testing. Finite Element Analysis has been carried out to access the effect of new sizes on the structural properties of the implant. Test results show the new components are not the new worst case when compared to the approved Reliance Lumbar IBF PEEK, 1-04-XXX, per K113540.

Technological Modifications

The subject Reliance Lumbar IBF system offers additional components. These new components differ in size.

All implants under Reliance Lumbar IBF System which are intended to be sold sterile, will be sterilized using Gamma Irradiation before shipping.

The subject Relianace Lumabr IBF System will have same indication of use as the currently approved Reliance Lumbar IBF System (K113540, K160463, K173283, and K180687).

Conclusion

The subject implants does not create a new worst case condition for mechanical testing, performance testing, sterilization, biocompatibility, cleaning or packaging. Sterilization method for subject components intended to be sold sterile, was validated.

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.