The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

Device Description

The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.

AI/ML Overview

This K063637 510(k) summary is for a spinal intervertebral body fixation orthosis, the Reliance VBS System. This is a traditional medical device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable here.

The document details the device's description, intended use, and its substantial equivalence to other legally marketed predicate devices based on material, intended use, levels of attachment, size range, and use with supplemental fixation.

Here's the information that can be extracted from the provided text, re-contextualized to highlight why AI/ML specific criteria are not present:

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

Acceptance Criteria (Relevant for AI/ML)	Reported Device Performance (Relevant for AI/ML)
Not Applicable (AI/ML device)	Not Applicable (Traditional medical device)

Explanation: This summary does not define specific "acceptance criteria" in the quantitative performance sense that would be typically found for an AI/ML device (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, for this traditional spinal implant, acceptance is based on demonstrating substantial equivalence to predicate devices. This means the device performs similarly, has similar materials, intended use, and design principles as devices already approved for market.

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

Sample Size for Test Set: Not applicable. There is no "test set" in the context of an AI/ML performance evaluation.
Data Provenance: Not applicable. The device relies on demonstrating equivalence to existing, legally marketed predicate devices, not on a data-driven performance study.

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)

Not applicable. There is no "ground truth" to be established by experts for a performance study of this traditional implant. The evaluation is based on engineering principles, material science, and comparison to predicate devices.

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

Not applicable. There is no "test set" or need for adjudication for a performance study.

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 not an AI-assisted diagnostic or treatment planning device, so an MRMC study is irrelevant.

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

Not applicable. There is no algorithm to evaluate.

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

Not applicable. Ground truth is not a concept applied in this 510(k) for a traditional implant. The "truth" in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no training set for an AI/ML model for this device.

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

Not applicable.

Summary specific to K063637:

The K063637 document demonstrates substantial equivalence of the Reliance VBS System to several predicate devices. This involves comparing aspects like:

Materials: PEEK or Titanium alloy for the implant components.
Intended Use: Used in the thoracolumbar spine (T1-L5) for vertebral body replacement due to tumor or trauma to restore height and achieve decompression, for a prolonged period, even without fusion.
Indications for Use: Exactly matches the intended use, including the requirement for use with a legally cleared anterior or posterior supplemental fixation device and bone graft.
Levels of Attachment: Thoracolumbar spine (T1-L5).
Size Range: Implied to be comparable to predicate devices.
Use with Supplemental Fixation: Explicitly stated, mirroring predicate devices.

The "study" to prove this device meets "acceptance criteria" (which in this case is substantial equivalence) is the 510(k) submission itself, which provides the detailed comparison to the predicate devices as found in the full submission. The FDA's review and clearance of the 510(k) (as evidenced by the letter dated SEP 27 2007) signifies that the company successfully demonstrated this substantial equivalence. No specific clinical trials or performance studies, as would be required for novel or high-risk devices, are detailed in this summary because substantial equivalence to existing devices was established for market clearance.

Summary

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K063637

510(k) Summary

Reliance Medical Systems 1838 E 9800 South Sandy, UT 84092 Telephone: 801-718-7467 Fax: 801-294-0079

Contact: Bret M. Berry Member-Manager

Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:

PEEK or Titanium Bone Fixation Appliance Reliance VBS System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 MQP

Substantial Equivalence

The Reliance VBS is substantially equivalent to the legally marketed Pioneer Surgical Vertebral Spacer (K043206), the Alphatec NOVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (K051454), the Medtronic Sofamor Danek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (K011037, K020152, K024364). The Reliance VBS 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

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

SEP 2 7 2007

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual one.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Reliance Medical Systems, LLC % Mr. Bret M. Berry Member-Manager 1838 E 9800 South Sandy, Utah 84092

SEP 2 7 2007

Re: K063637

Trade/Device Name: Reliance VBS System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 29, 2007 Received: July 2, 2007

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Bret M. Berry

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Millhurn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063637_

Device Name: _Reliance VBS System

Indications for Use:

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

Mark A. Millheiser

(Division Sign-Oif) Division of General. Restorative, and Neurological Devices

510(k) Number K063637

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.