EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM by EBI, L.P.

The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The EBI SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for design modifications to the previously cleared 4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and the associated instrumentation.

AI/ML Overview

The provided document, K993822, is a 510(k) summary for a medical device (EBI SpineLink™ Anterior Cervical Spinal System). It is a regulatory submission for pre-market notification of a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria. This type of submission does not typically include the detailed information requested in your prompt regarding acceptance criteria, study design, ground truth establishment, or sample sizes related to performance evaluation in the way you might expect for an AI/CADe device.

Therefore, many of your requested points cannot be extracted from this document, as they are not relevant to a 510(k) for a spinal fixation system that relies on substantial equivalence.

Here's an analysis based on the information available in the document:

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

This document does not specify quantitative "acceptance criteria" or report "device performance" in terms of clinical outcomes or diagnostic metrics. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" aspect is addressed by an "Engineering Analysis comparing the modifications to the previous system," which "demonstrated that the device complies with applicable standards and meets all of its functional requirements." However, the specific standards, functional requirements, and the results of this analysis are not detailed in this summary.

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

Not applicable. This is a spinal fixation system, not a diagnostic device evaluated with test sets of data. The submission relies on engineering analysis and comparison to predicate devices, not clinical data sets in the context you describe.

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. Ground truth, in the context of diagnostic or AI studies, is not established for this type of device submission.

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

Not applicable.

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 a spinal fixation system, not an AI or diagnostic tool.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable. This document is not about an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary of what is provided in the document related to "acceptance criteria" and "study":

The document states that an Engineering Analysis was performed to compare the modified device components (4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and associated instrumentation) to the previous cleared system.

Acceptance Criteria (Implied): The device complies with "applicable standards" and "meets all of its functional requirements." The specific standards and functional requirements are not detailed but would be related to mechanical strength, biocompatibility (materials: Ti-6A1-4V ELI per ASTM F136), and design integrity for a spinal implant.
Study: The "Engineering Analysis" serves as the "study." This would involve mechanical testing, material characterization, and design review to ensure the modifications do not adversely affect safety or effectiveness compared to the predicate. The document states: "An Engineering Analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements."

In conclusion, this 510(k) summary for a spinal fixation device focuses on substantial equivalence based on engineering analysis and material comparisons, not detailed clinical trial data or performance against diagnostic acceptance criteria as is common for AI/CADe devices.

Summary

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DEC I O 1899

K993822

510(k) Summary of Safety & Effectiveness

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

Contact Person: Jon Caparotta 1. Submitter: EBI, L.P. Telephone: (973) 299-9022 100 Internace Parkwav Parsippany, NJ 07054
November 9, 1999 Date prepared:

2. Proprietary Name:	EBI SpineLink™ Anterior Cervical Spinal System
Common Name:	Spinal Fixation Device
Classification Names:	Spinal Intervertebral Body Fixation Orthosis

3. Predicate or legally marketed devices that are substantially equivalent:

EBI SpineLink™ Anterior Cervical Spinal System �
Synthes® Cervical Spine Locking Plate �
1. Description of the device: The EBI SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for design modifications to the previously cleared 4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and the associated instrumentation.
1. Intended Use: The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and

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radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

1. Materials: The components of the System are manufactured from Ti-6A1-4V ELI per ASTM F136.
1. Comparison of the technological characteristics of the device to predicate

devices: There are no significant differences between the EBI SpineLink™ Anterior Cervical Spinal System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function. An Engineering Analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.

* 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 lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Image /page/2/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 representation of three human profiles facing right, arranged in a stacked formation. The profiles are connected and appear to be flowing or merging into one another. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the top half of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1999

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

Re: K993822

Trade Name: EBI SpineLink™ Anterior Cervical Spinal System Regulatory Class: II Product Code: KWQ Dated: November 11, 1999 Received: November 12, 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 (QS) 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.

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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,

Stypka Schueler

1 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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K993822 Statement of Indications for Use:

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Hupt Purdy

vision of General Restorative Deyices 510(k) Number .

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

N/A