degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) lumors pseudarthrosis failed previous fusion (pseudarthrosis)

When used as an anterolaterallanterior system the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studios spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosls)

When used as a posterior pedicle svstem. the device is indicated for use in skeletally mature patients L3 & below who are:

having severe spondylollsthesis (Grades 3 and 4) at the L5-S1 joint

receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine

having the device removed after the development of a solid fusion mass.

Posterior pedicle systems are 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 neurologic impairment fracture dislocation scoliosis kyphosis spinal turnor failed previous fusion (pseudarthrosis)

Device Description

This new connector is called the “Omni Axial Connector.” The part number is 7T20-CO04. It is made from titanium alloy as defined by the ASTM and ISO standards indicated below, TA6V ELI ASTM F136-92 ISO 5832-3. The Omniaxial Connector facilitates pedicle screw insertion by providing a range of adaptability of the screw path in the three axist, axial, sagittal and coronal. The OmntAxtal Connector is intended to be a "standard" component of the SCS Spinal System. The OmniAxtal Connector attaches to the spinal rods using the same connecting screw (2TD1-VS53) as used in the existing SCS Spinal System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ORTHOTEC, LLC. OmniAxial Connector, based on the provided document:

This document is a 510(k) premarket notification for a medical device connector. The acceptance criteria and the study presented are focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving absolute clinical effectiveness or diagnostic accuracy as seen in AI/CADe devices. Therefore, many of the typical questions for AI/CADe will not be directly applicable (e.g., ground truth for training set, MRMC studies, effect size of AI assistance).

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from Special Controls & Guidance)	Reported Device Performance	Comments
Material Standards: Compliance with ASTM F136-92 and ISO 5832-3 for TA6V ELI titanium alloy.	Device is made from TA6V ELI titanium alloy, compliant with ASTM F136-92 and ISO 5832-3.	Met.
Mechanical Testing Standard: (ASTM F-1717-96 guidance document used)	Mechanical and fatigue testing carried out using ASTM F-1717-96. Static testing demonstrated substantial equivalence to the predicate device.	Met. The tests demonstrated that the new connector performs equivalently to the previously cleared connector.
Biocompatibility Standard: (Implicit from the "Special Controls")	Not explicitly detailed in the provided text as a separate study result, but compliance with material standards (titanium alloy) generally implies biocompatibility for spinal implants. No adverse biocompatibility issues were reported for the predicate which implicitly carries over.	Assumed met through material selection and predicate equivalence.
Labeling Requirements: Compliance with specified labeling.	The 510(k) submission includes labeling information. The FDA's response confirms the device can be marketed.	Met.
Substantial Equivalence: The OmniAxial Connector performs essentially the same function as the original connector (SCS Spinal System, K983353). Basic design, dimensional tolerances, materials, and intended use are identical or equivalent.	Design: "SAME"; Sterile: "Non-sterile" (SAME); Sizes: "EQUIVALENT" (6-7mm dia. X 30-55mm length vs. predicate); Material: "SAME" (Stainless steel, titanium alloy, pure titanium); Manufacturer: "SAME"; Product Code: "SAME".	Met. The overall conclusion is substantial equivalence.
cGMP Regulations: Product manufactured in compliance with cGMP.	"The product is manufactured in compliance with cGMP regulations."	Met.

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

Test Set Sample Size: The document does not specify a numerical sample size for the mechanical and fatigue testing in terms of individual devices or components tested. It generally states that "Samples were tested."
Data Provenance: Not applicable in the context of clinical data. The data provenance refers to mechanical and fatigue testing conducted by the manufacturer, ORTHOTEC, LLC. The testing is internal to the manufacturer for engineering validation.

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

Not applicable. For this type of device (spinal implant connector), "ground truth" is established through engineering specifications, material standards, and benchmark testing against a predicate device, rather than expert clinical consensus on patient data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. This submission concerns mechanical performance. The "adjudication" is essentially the manufacturer's testing and a regulatory body's (FDA) review of that testing against established standards and predicate device data.

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:

No. This is not an AI/CADe device. No MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device. The "standalone performance" is the mechanical performance of the component itself, which was tested.

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

For this device, the "ground truth" is defined by:
- Engineering Standards: ASTM F-1717-96 guidance document for mechanical and fatigue testing.
- Material Specifications: ASTM F136-92 and ISO 5832-3 for TA6V ELI titanium alloy.
- Predicate Device Performance: The mechanical and functional characteristics of the previously cleared SCS Spinal System connector (K983353).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical medical device.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

Summary

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Summary of Safety and Effectiveness Information ORTHOTEC, LLC.
Premarket Notification, Section 510(k)	NOVEMBER 1999
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1.	Device Name:
	Trade Name:	OmniAxial Connector (SCS Spinal System)
	Common Name(s):	pedicle screw spine system
	Classification Name(s):	Pedicle Screw Spinal System (Class II Uses)
2.	Establishment Name & Registration Number:
	Name:	ORTHOTEC, LLC.
	Number:	2031734
3.	Classification:
	§ 888.3070 – Spondylolisthesis Spinal Fixation Device System§ 888.3070 – Pedicle Screw Spinal System (Class II Uses)
	Device Class:	Class II for the requested indications
	Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
	Product Code(s):	KWP KWQ & MNH, MNI
4.	Equivalent Predicate Device:The OmniAxial Connector may be directly contrasted with the earlier screw-rod connector of theSCS Spinal System, K983353 . The OmniAxial Connector performs essentially the same functionas the original connector. The basic design, dimensional tolerances, materials and intended useof both devices are identical.
5.	Device Description:This new connector is called the “Omni Axial Connector.” The part number is 7T20-CO04. It is

made from titanium alloy as defined by the ASTM and ISO standards indicated below,

TA6V ELI	ASTM F136-92	ISO 5832-3
----------	--------------	------------

The Omniaxial Connector facilitates pedicle screw insertion by providing a range of adaptability of the screw path in the three axist, axial, sagittal and coronal. The OmntAxtal Connector is intended to be a "standard" component of the SCS Spinal System. The OmniAxtal Connector attaches to the spinal rods using the same connecting screw (2TD1-VS53) as used in the existing SCS Spinal System.

Summary of the Testing:

Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. The maximum and minimum loads, positions and temperatures were recorded. Static testing sufficient to quantify and compare the previously cleared SCS Spiral System connector and the new Omotiaxial Connector clearly demonstrates the substantial equivalence of the two connectors. The product is manufactured in compliance with cGMP regulations.

6. Applicant Name & Address:

ORTHOTEC, LLC. 546 Hillgreen Drive Beverly Hills, CA 90212-4110 310.557.2000 - 310.843.9500 - fax

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K993926 2 of 3

7. Company Contact:

Regulatory Affairs ORTHOTEC, LLC. 546 Hillareen Drive Beverly Hills, CA 90212-4110 310.557.2000 ~ 310.843.9500 - fax

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, LLC. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality requlations. ОятноТес, LLC. In addition, meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

10. Special Controls:

Special controls were published in the Federal Register, Vol. 63, No. 143. July 27, 1998 (Orthopedic Devices: Classification and Reclassification of Pedicie Screw Spinal Systems). The following special controls apply to the marketing of this device when used as a posterior pedicle system:

Compliance with material standards, (i)
Compliance with mechanical testing standard, ( ii )
Compliance with biocompatability standard, and ( iii)
Compliance with specified labeling requirements. (iv)

11. Special Guidance Document Information:

The 510(k) was prepared in accordance with:

. "Guidance for Spinal System 510(k)'s," May 7. 1999.
. "The New 510(k) Paradigm. Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance, March 20, 1998.

12. Storage, Packaging & Sterilization Information:

The Omniaxtal Connector is supplied "NON-STERILE" and must be sterilized before use. The recommended sterilization process is high temperature steam autoclave sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°5

The validated cycle is:

Method: Steam Cycle: Gravity Temperature: 250°F (121°C) Exposure Time: 30 minutes

All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned.

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Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

13.	Summary Comparison Table:

FEATURE	SCS Spinal System OmniAxial Connector	SCS Spinal System	SE?
Indications forUse:	As a Non-pedicle posterior system: spondylolisthesis, fracture, spinalstenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors,pseudarthrosis, failed previous fusion (pseudarthrosis).As a Anterolateral/anterior system: spondylolisthesis, fracture, spinalstenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors,pseudarthrosis, failed previous fusion (pseudarthrosis).As a Posterior pedicle system: degenerative spondylolisthesis withobjective evidence of neurologic impairment, fracture, dislocation, scoliosis,kyphosis spinal tumor, failed previous fusion (pseudarthrosis), severespondylolisthesis (Grades 3 and 4) at the L5-S1 joint, Fusions usingautogenous bone graft only, Device fixed or attached to the lumbar andsacral spine, device removed after the development of a solid fusion mass.	SAME	YES
Design:	OmniAxial pedicle screw	SAME	YES
Sterile:	Non-sterile	SAME	YES
Sizes:	OmniAxial Pedicle Screws: 6-7mm dia. X 30-55mm length	EQUIVALENT	YES
Material:	Stainless steel, titanium alloy, pure titanium	SAME	YES
Manufacturer:	OrthoTec, LLC.	OrthoTec, LLC.	YES
Product Code:	KWP KWQ & MNH	SAME	YES
K - Number:	K993926	K983355	YES

14. Intended Use:

When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) fumors pseudarthrosis falled previous fusion (pseudarthrosis)

When used as an anterolateral/anterior system the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudanthrosis)

When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:

having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint

receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine

having the device removed after the development of a solid fusion mass,

Posterior pedicle systems are 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:

spondylolisthesis with objective degenerative evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor falled previous fusion (pseudarthrosis

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 1999

Mr. David W. Schlerf OrthoTec, LLC c/o Buckman Company, Inc. 200 Gregory Lane. Suite C-100 Pleasant Hill. California 94523-3389

Re: K993926 Trade Name: SCS Spinal System Regulatory Class: II Product Code: MNH. KWO. KWP. and MNI Dated: October 11, 1999 Received: November 18, 1999

Dear Mr. Schlerf:

We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. David W. Schlerf

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Xennell Hayes
James E. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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રે

510(k) Number : K993926

Device Name(s): Omni-axial Connector (SCS Spinal System)

Intended Use(s) of the Device:

When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) lumors pseudarthrosis failed previous fusion (pseudarthrosis)

When used as an anterolaterallanterior system the SCS system is indicated for patients with:

When used as a posterior pedicle svstem. the device is indicated for use in skeletally mature patients L3 & below who are:

Page 1 of ___ of _____________________________________________________________________________________________________________________________________________________________

having severe spondylollsthesis (Grades 3 and 4) at the L5-S1 joint

receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine

having the device removed after the development of a solid fusion mass.

degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal turnor failed previous fusion (pseudarthrosis)

please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)

luneh Lager 84 577

Prescription Use __ 1. (Per 21 CFR 801.109)

Over-The-Counter Use_

Over-The-

Regulation Number and Section

N/A