The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

Device Description

The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Reliance Cervical IBF System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with clinical performance or efficacy studies.

Instead, the "Performance Data and Substantial Equivalence" section refers to engineering and manufacturing performance testing to demonstrate that the new device, which has a material modification (Titanium 6Al-4V ELI) compared to its predicates (PEEK Optima LT1 or PEEK Optima LT1-HA), is still substantially equivalent to the predicates. Therefore, many of the requested categories cannot be filled from this document as they pertain to clinical or diagnostic performance studies, which are not described here.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information regarding "acceptance criteria" and "study proving the device meets acceptance criteria" in a clinical performance context is not present.

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or clinical success rates). Instead, it refers to compliance with engineering and manufacturing standards. Therefore, a table of clinical acceptance criteria and reported device performance cannot be generated from this text. The performance data mentioned relates to demonstrating substantial equivalence for engineering properties.

Acceptance Criteria Category (Implied)	Reported Device Performance (Reference to Standards)
Mechanical Performance	Compliance with ASTM F2077-18 and F2267-04 (2018) standards
Packaging Integrity	Compliance with ASTM D4169, D4332, F88, F1886, F2096
Cleaning Validation	Compliance with ASTM F2459 and F2847
Sterilization Efficacy	Compliance with ANSI/AAMI/ISO 11137-1:2006/A1:2013/A2:2019, ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006, ANSI/AAMI/ISO 11737-2:2009, and ANSI/AAMI/ISO TIR13004:2013
Biocompatibility	Determined to be substantially equivalent to predicate devices

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The performance data described are related to engineering and manufacturing tests, not clinical test sets.

3. 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)

This information is not provided as there is no description of a clinical test set requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no description of a clinical test set requiring adjudication.

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

There is no mention of an MRMC study or AI in this document. This device is an intervertebral body fusion system, not an AI/imaging diagnostic device.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as there is no description of a clinical test set requiring ground truth. The "ground truth" for the engineering tests would be the specifications outlined in the referenced ASTM/ISO standards.

8. The sample size for the training set

This information is not provided as there is no mention of a training set, which is typically associated with AI/machine learning models or studies involving clinical data for training.

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

This information is not provided as there is no mention of a training set or how its ground truth would be established.

Summary regarding the device and the document:

This 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to existing, legally marketed predicate devices. The modification is primarily a change in material for the intervertebral body fusion spacer, from PEEK to Titanium 6A1-4V ELI.

The "study that proves the device meets the acceptance criteria" in this context refers to a battery of engineering and manufacturing tests (mechanical, packaging, cleaning, sterilization, biocompatibility) conducted according to recognized ASTM and ISO standards. The "acceptance criteria" are implied to be the successful compliance with these standards, demonstrating that the new material does not negatively impact the device's fundamental safety and effectiveness compared to the predicate, making it substantially equivalent.

The document does not describe any clinical trials, performance studies, or efficacy studies involving human subjects or clinical data in the form requested to directly assess performance metrics like sensitivity, specificity, or clinical outcomes. For intervertebral body fusion devices in the 510(k) pathway, such extensive clinical performance studies are often not required if substantial equivalence can be demonstrated through other means (e.g., material testing, biomechanical testing, and comparison of design/indications to predicates).

Summary

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March 29, 20222

Reliance Medical Systems, LLC Bret Berry Owner P.O. Box 1693 Bountiful, Utah 84010

Re: K202266

Trade/Device Name: Reliance Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 24, 2022 Received: February 28, 2022

Dear Bret 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

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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,

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) K202266

Device Name Reliance Cervical IBF System

Indications for Use (Describe)

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

Reliance Medical Systems, LLC 545 West 500 South Suite 100 Bountiful, UT 84010 Telephone: (801) 295-3280 Fax: (801) 294-0079

Contact: Bret M. Berry, Member-Manager 510(k) Number: K202266 Common or Usual Name: Intervertebral Body Fusion Device Proposed Proprietary or Trade Name: Reliance Cervical IBF System Classification Name: Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Product Code: ODP

Substantial Equivalence:

The subject Reliance Cervical IBF System is substantially equivalent to the legally marketed predicate devices, the Reliance Cervical IBF System (K120396/K131429/K172489/ K173102, with K173102 as the primary predicate) and the Nexxt Spine Matrixx System (K171140). The subject Reliance Cervical IBF System is equivalent to its commercially available predicates in terms of intended use, indications for use, design, function, principle of operation, materials, levels of attachment, size range, strength and use with supplemental fixation.

Device Description:

Intended Use / Indications for Use:

29 March 2022

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Technological Modifications:

The subject Reliance Cervical IBF system offers intervertebral body spacers in an additional material, Titanium 6A1-4V ELI. There have been no changes to intended use, indications for use, function, principle of operation, sizes or size range, levels of attachment, or method of insertion.

Performance Data and Substantial Equivalence:

The Reliance Cervical IBF device was subjected to performance testing that followed ASTM F2077-18 and F2267-04 (2018) standards. Additionally, the porous lattice structures within the implants presented a new worst-case scenario for sterilization, cleaning and packaging. Therefore, packaging testing was performed according to the following ASTM standards: D4169, D4332, F88, F1886 and F2096, and cleaning validation in accordance to the following ASTM standards: F2459 and F2847. Sterilization was performed to the following standards: ANSI/AAMI/ISO 11137-1:2006/A1:2013/A2:2019, ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006, ANSI/AAMI/ISO 11737-2:2009, and ANSI/AAMI/ISO TIR13004:2013. The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of biocompatibility.

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.