The FOREX Corporation, OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Device Description

The OPTIMATM Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system.

AI/ML Overview

The information provided describes the FOREX Corporation OPTIMA™ Spinal System, a medical device. The document primarily focuses on its 510(k) submission for market clearance, establishing substantial equivalence to predicate devices, and thus does not directly address typical acceptance criteria and performance studies commonly seen in AI/ML device submissions.

Instead, the "acceptance criteria" for this device are met through demonstrating substantial equivalence to already legally marketed predicate devices, and the "study" proving this involves bench testing.

Here's how to frame the requested information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Demonstration of Equivalence)	Reported Device Performance (Bench Testing Result)
Equivalence in materials to predicate devices	Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices.
Equivalence in design to predicate devices	Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices.
Equivalence in operational principles to predicate devices	Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices.
Equivalence in indications for use to predicate devices	Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- The document states "Bench testing as listed in Section XII". Section XII is not provided, so the specific sample size for the bench tests is not specified in the given text.
- The data provenance is from bench testing, meaning in-vitro mechanical and material tests, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. Bench testing for mechanical properties does not typically involve human expert adjudication for ground truth. The "ground truth" for these tests would be the measured physical properties compared against established engineering standards (ASTM F1717) and the properties of predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Bench testing results are typically objectively measured and do not require adjudication by experts in the same way clinical or imaging studies might.
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:
- No, an MRMC comparative effectiveness study was not done. This is a spinal implant system, not an AI or imaging device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench testing was established by standardized mechanical testing protocols (ASTM F1717) and engineering specifications. The performance was compared to that of legally marketed predicate devices.
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- This is not applicable as there is no training set for a physical implant device.

Summary

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JUN 2 0 2002

Forex Corporation

6132 South 380 West . Suite # 200 . Murray, Utah 84107 . Phone: (801) 262-3100 62-3151

510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

Submission Information:

Contact:

Robert Malone Corporate Manager, Regulatory Affairs and Quality Assurance

Sponsor:

FOREX Corporation 6132 South 380 West Murray, UT 84107 Phone: 801.262.3100 Fax: 801.262.3151

Date Prepared:

May 20, 2002

Device Identification:

Trade Name: FOREX Corporation, OPTIMA™, Spinal System

Common Name:

Classification Name:

. Pedical Screw Spinal Fixation System

Spinal Pedical Screw (MNI) per 21 CFR § 888.3070

Spondylolisthesis Spinal Fixation Device System (MNH) per 21 CFR § 888.3070

Spinal Intervertebral Body Fixation Orthosis (KWQ) per 21 CFR § 888.3060

Substantially Equivalent Predicate Legally Marketed Devices:

Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryker® Spine, Xia™ Spinal System -- MNH, MNI, KWQ -- (K001319)

The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.

Device Description:

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Ko20279
$$r^2/2$$

The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system.

Indications for Use:

The FOREX Corporation, OPTIMATM posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion bv autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Statement of Technological Comparison:

The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles.

Performance Data:

Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

JUN 2 0 2002

Mr. Robert Malone Corporate Manager, Regulatory Affairs and Quality Assurance FOREX Corporation 6132 South 380 West Suite 200 Murray, Utah 84107

Re: K020279

Trade Name: FOREX Corporation, OPTIMA™ Spinal System Regulatory Number: 21 CFR 888.3070 and 21 CFR 888.3060 Regulatory Name: Pedicle screw spinal system, Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWQ Dated: April 23, 2002 Received: April 24, 2002

Dear Mr. Malone:

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. Robert Malone

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION II

INDICATIONS for USE STATEMENT

510(k) Number (if known): ¥(220279

Device Name: FOREX Corporation, OPTIMA™ Spinal System.

Indications for Use: The FOREX Corporation, OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal seaments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	for Mark A Milkerson
	(Division Sign-Off)
	Division of General, Restorativeand Neurological Devices
510(k) Number	K020279
Prescription Use
	OR Over-the-Counter Use (Per 21 CFR 801.109)(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.