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

When used as a pedicle screw fixation system, 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; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

Device Description

The EBI SpineLink™ System with Link Tie is a spinal fixation device for the interconnection of two links.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (EBI SpineLink™ System with Link Tie), not a study analyzing device performance against acceptance criteria. A 510(k) is a submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process does not typically involve detailed studies with acceptance criteria in the manner requested for a new device's efficacy or accuracy.

Therefore, most of the requested information (such as acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided document. The document focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and materials, rather than presenting a performance study with detailed statistical outcomes.

Here's what can be gathered from the text, indicating the type of assessment rather than the specifics of a performance study:

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

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial equivalence to predicate devices regarding intended use, materials, and function.	"Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements."

Explanation: The "acceptance criteria" here are not numerical performance thresholds but rather the regulatory requirement of demonstrating substantial equivalence to predicate devices, supported by bench testing results that show compliance with standards and functional requirements. Specific numerical performance metrics are not provided.

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

Sample Size: Not applicable/Not mentioned. The document refers to "bench testing," which typically involves mechanical testing of device components, not a clinical "test set" in the context of diagnostic or AI performance evaluation.
Data Provenance: Not applicable/Not mentioned.

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):

Number of Experts: Not applicable/Not mentioned. This type of information is pertinent to studies involving human interpretation or clinical data, which is not the subject of this 510(k) summary.
Qualifications of Experts: Not applicable/Not mentioned.

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

Adjudication Method: Not applicable/Not mentioned.

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:

MRMC Study: No, an MRMC study was not done. This is a medical device for spinal fixation, not an AI or diagnostic imaging device.

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

Standalone Performance: Not applicable. This is a physical medical implant, not an algorithm.

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

Type of Ground Truth: Not applicable. The "bench testing" mentioned compares the device to a predicate system against "applicable standards" and "functional requirements," indicating objective engineering and material property measurements rather than clinical "ground truth."

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/Not mentioned. This pertains to machine learning models, not mechanical devices.

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

Ground Truth Establishment for Training Set: Not applicable/Not mentioned.

Summary:

The provided text is a 510(k) submission for a physical spinal fixation device. Its purpose is to demonstrate substantial equivalence to existing devices through comparison of intended use, materials, and general function, supported by "bench testing." It does not contain the detailed performance study information typically requested for AI-enabled diagnostic devices or software, such as clinical test sets, expert ground truth, or statistical performance metrics.

Summary

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AUG-13-1997 14:19

K971970 1 of 2

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI SpineLink™ System with Link Tie is provided as required per Section 513(D)(3) of the Food, Drug and Cosmetic Act.

Submitter: Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054 Contact Person: Jon Caparotta Telephone: (201) 299-9022

AUG 20 1997

Date prepared: August 13, 1997

Proprietary Name: EBI SpineLink™ System Spinal Fixation Device Common Name: Classification Names:Spondylolisthesis Spinal Fixation Device System Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis
Predicate or legally marketed devices that are substantially equivalent:

· EBI SpineLink™ System

· Webb-Morley Spine System Electro-Biology, Inc.
· Isola® Spine System AcroMed Corporation
· TSRH® Spinal System Sofamor Danek
· KSF Spinal Fixator Tornier SA
· Dyna-Lok® Spine System Sofamor Danek
· VSP® Plating System AcroMed Corporation
Description of the device: The EBI SpineLink™ System with Link Tie is a spinal 4. fixation device for the interconnection of two links.
1. Intended Use: The EBI SpineLink™ System with Link Tie has not changed the Indications for Use of the recently cleared EBI SpineLink™ System (K964797). The EBI SpineLink™ System with Link Tie is a spinal fixation device for pedicle screw fixation and nonpedicle

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R97197C

hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vercebral 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; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to LJ- S1 or iliac screw fixation with the fusion only at LS-S1.

1. Materials: The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136. The components will be available with and without TiN coating.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between EBI SpineLink System Link Tie and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements.

Any statement made in conjunction with this submission regroling a decemination of substantial equivalence to any other intended only to relate to whether the product our be la provinces approval or reclassification and is not intended to be interpresed as an admission or any other in prent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preunthle, August 23, 1977, FR 42520 (Docker No. 76N-0555)]

3.0

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top and sides of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Caparotta Manager, Requlatory Affairs Electro-Biology, Inc. 6 Upper Pond Road Parsippany, New Jersey 07054-1079

AUG 20 1997

K971970 Re: SpineLink™ System Requlatory Class: II Product Codes: MNH, KWP and KWQ Dated: May 28, 1997 Received: May 29, 1997

Dear Mr. Caparotta:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act) . . found equivalent only to similar device systems labeled and 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; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act.

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This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III Severe Sponajierson 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing: Accordingly: mainto

All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only 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; and (d) who are having the device removed after the development of a solid fusion mass.
You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS :

When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may require additional surgery, include:

device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

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Page 3 - Mr. John Caparotta

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item l, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

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 (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou might have under sections 531 ihrough 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

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Page 4 - Mr. John Caparotta

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

If you desire specific advice for your device on our labeling requlation (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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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Statement of Indications for Use:

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

Prescription Use
(Per 21 CFR 801.109) X

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Division Sign-Off) Division of General 510lk) Number

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.