EBI OMEGA 21 SYSTEM by ELECTRO-BIOLOGY, INC.

The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, 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, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or turnor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

Device Description

The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, and couplers. This submission is for expanding the range of screw sizes to offer an additional 7 and 8mm expansive screw.

AI/ML Overview

The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI Omega 21™ System, a spinal fixation device. This document is a regulatory submission to the FDA for market clearance, primarily focused on showing substantial equivalence to previously cleared devices.

Based on the information provided in the input, here's a breakdown of the requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: The EBI Omega 21™ System must demonstrate equivalent structural integrity and mechanical properties to the predicate devices. This includes aspects like fixation strength, resistance to fatigue, and general stability under physiological loads.	The submission directly states: "There are no significant differences between the EBI Omega 21™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to... function." This implies that the device meets the functional expectations and performance characteristics of the predicate devices. The expansion to new screw sizes (7 and 8mm expansive screw) would have been supported by internal testing to demonstrate these new components maintain the equivalent performance of the overall system.
Material Biocompatibility: Components must be made from biocompatible materials suitable for long-term implantation.	"The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136." This material is a widely accepted and established biocompatible material for implantable medical devices. Compliance with ASTM F136 directly addresses this criterion.
Dimensions and Specifications: New screw sizes (7mm and 8mm expansive screws) must meet specified dimensional tolerances and be compatible with the existing EBI Omega 21™ System.	While specific dimensions are not listed, the submission is focused on "expanding the range of screw sizes to offer an additional 7 and 8mm expansive screw." This implies these new sizes were specifically designed and manufactured to integrate with the existing system and meet the necessary specifications.
Safety Profile: The device should not introduce new safety concerns compared to the predicate devices.	The core of a 510(k) submission is to demonstrate substantial equivalence, which inherently includes safety. By stating "There are no significant differences between the EBI Omega 21™ System and other currently marketed spinal systems," and that it is "substantially equivalent* to the predicate devices," the manufacturer asserts that the safety profile is comparable and acceptable.

Study Proving Acceptance Criteria:

The document describes a reliance on substantial equivalence rather than presenting a detailed de novo clinical or non-clinical study designed with specific acceptance criteria in the manner of an AI/software device. The entire 510(k) submission itself serves as the "study" or evidence package demonstrating that the EBI Omega 21™ System, with the expanded screw sizes, meets the acceptance criteria by being "substantially equivalent" to its predicate devices (EBI Omega 21™ System, EBI SpineLink™ System).

This type of submission for a spinal fixation device typically involves:

Bench Testing: Mechanical testing (e.g., static and fatigue testing, pull-out strength, torsional strength) of the new screw sizes and the overall system to demonstrate performance comparable to the predicate devices and relevant ASTM standards. Although not explicitly detailed in this summary, such testing would be included in the full submission.
Material Characterization: Verification that the materials meet ASTM F136 standards.
Comparison to Predicate Devices: A detailed comparison of design, materials, intended use, and performance characteristics between the new device (with expanded screw sizes) and the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal implants, samples would typically consist of a certain number of devices or components tested according to relevant ASTM or ISO standards to ensure statistical validity. This is not a "test set" in the context of clinical data for AI, but rather a set of physical devices subjected to engineering tests.
Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The "studies" for this type of submission are primarily non-clinical (bench) tests and material analyses, not human clinical trials in the conventional sense for the aspect of adding new screw sizes. The provenance would be the manufacturing site and testing laboratories of Electro-Biology, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of the provided document. Ground truth, in this context, would be established by:

Engineering standards (e.g., ASTM F136 for materials, other ASTM/ISO standards for mechanical performance).
Performance data from the legally marketed predicate devices.
Regulatory requirements for spinal fixation devices.

The "experts" involved are likely internal engineering and regulatory teams at Electro-Biology, Inc., and potentially external independent testing labs. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) are the regulatory experts who evaluate the submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from expert readings of medical images or clinical outcomes, which is not the type of data or study described here. Acceptance is based on meeting pre-defined engineering and material standards, and demonstrating substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, this type of study was not done. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or AI algorithms when interpreted by multiple human readers, often comparing performance with and without AI assistance. This submission is for a physical orthopedic implant.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, this is not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Engineering Standards: Compliance with ASTM F136 for materials and other relevant biomechanical standards for spinal implants.
Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices, particularly the existing EBI Omega 21™ System and EBI SpineLink™ System. The new components are expected to perform comparably.
Regulatory Requirements: Fulfillment of FDA's regulatory requirements for spinal fixation devices as outlined in 21 CFR sections pertaining to classification, manufacturing, and labeling.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of AI or machine learning for this physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied for this physical medical device.

Summary

{0}------------------------------------------------

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI Omega 21™ System is provided as required per Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.

Ion Caparotta, Manager Regulatory Affairs 1. Sponsor: Electro-Biology, Inc. 100 Interpace Parkway Parsippany, NJ 07054

Contact Person: Jonas Wilf Telephone: (973) 299-9300

Date prepared: July 12, 1999

Proprietary Name: 2. Common Name: Classification Names:

EBI Omega 21 TM System Spinal Fixation Device Spondylolisthesis Spinal Fixation Device System Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis

Predicate or legally marketed devices that are substantially equivalent: 3.
- EBI Omega 21™ System
- EBI SpineLink™ System
Description of the device: The EBI Omega 21™ System is a spinal fixation device 4. that uses rods, screws, and couplers. This submission is for expanding the range of screw sizes to offer an additional 7 and 8mm expansive screw.
1. Intended Use: The EBI Omega 21™ System has not changed the Indications for Use or fundamental scientific technology of the previously cleared EBI Omega 21™ System (K973683 and K990303). The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization of spinal segments, 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, dislocations, scolosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

{1}------------------------------------------------

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondriolisthesis, fracture; previous failed fusion; or tumor resection.

Materials: The components of the system are manufactured from Ti-6AI-4V ELI per 6. ASTM F136.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI Omega 21™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function

*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be kwfully market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registation and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

{2}------------------------------------------------

Image /page/2/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 image of an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

Mr. Jon Caparotta Manager. Regulatory Affairs Electro-Biology Incorporated 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K992333

Trade Name: EBI Omega 21 тм System Regulatory Class: II Product Code: MNI, MNH, KWP, and KWO Dated: July 12, 1999 Received: July 13, 1999

Dear Mr. Caparotta:

We have reviewed your 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 Quality 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.

{3}------------------------------------------------

Page 2 Mr. Jon Caparotta

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.

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,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

{4}------------------------------------------------

K992333

Statement of Indications for Use:

The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

bcotefz

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992333

Prescription Use
(Per 21 CFR 801.109)

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.