(28 days)
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.
The EBI SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 4.5mm diameter bone anchor screw.
The provided text describes a 510(k) summary for the EBI SpineLink™ Anterior Cervical Spinal System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market rather than providing detailed clinical study data with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in the provided text. The text primarily addresses regulatory compliance and safety/effectiveness through comparison to predicate devices, rather than a de novo clinical trial demonstrating performance against quantitative acceptance criteria.
However, I can extract the information that is present:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria or quantitative performance metrics typically seen in a clinical study report. Instead, the "acceptance criteria" can be inferred as demonstrating "substantial equivalence" to predicate devices and complying with applicable standards.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The EBI SpineLink™ Anterior Cervical Spinal System is substantially equivalent to the predicate devices (EBI SpineLink™ Anterior Cervical Spinal System and Synthes® Cervical Spine Locking Plate) in regards to intended use, materials, and function. |
| Compliance with Applicable Standards and Functional Requirements | "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The submission relies on comparative testing to demonstrate equivalence rather than a clinical trial with a "test set" of patients. The "testing comparing the modifications" likely refers to bench testing rather than human subject data.
- Data provenance: Not applicable/Not provided in terms of human subjects. The testing described would primarily involve mechanical or material testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth, typically established by experts in clinical studies, is not mentioned as this relates to a comparative device submission based on product characteristics and previous approvals.
4. Adjudication method for the test set
Not applicable/Not provided. Adjudication methods are relevant for clinical trials or studies involving expert review of outcomes, which are not detailed here.
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 medical device for spinal fixation, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI enhancement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal fixation device, not an algorithm or software.
7. The type of ground truth used
Not applicable/Not provided. The concept of "ground truth" as used in diagnostic or AI studies (e.g., pathology, outcomes data) does not apply to this device submission, which focuses on mechanical equivalence and safety.
8. The sample size for the training set
Not applicable/Not provided. Training sets are relevant for machine learning models, which this device is not.
9. How the ground truth for the training set was established
Not applicable/Not provided. See point 8.
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4/29/99
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(D)(3) of the Food, Drug and Cosmetic Act.
| 1. | Submitter: Electro-Biology, Inc.100 Interpace ParkwayParsippany, NJ 07054 | Contact Person: Jon CaparottaTelephone: (973) 299-9022 |
|---|---|---|
| ---- | ----------------------------------------------------------------------------------- | ------------------------------------------------------------ |
Date prepared: March 30, 1999
| 2. Proprietary Name: | EBI SpineLink™ Anterior Cervical Spinal System |
|---|---|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spinal Intervertebral Body Fixation Orthosis |
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- Predicate or legally marketed devices that are substantially equivalent:
- · EBI SpineLink™ Anterior Cervical Spinal System
- · Synthes® Cervical Spine Locking Plate
- Description of the device: The EBI SpineLink™ System is a cervical spinal fixation 4. device that uses interconnecting links. This submission is for the addition of a 4.5mm diameter bone anchor screw.
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- 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 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.
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- 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. Testing companing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
- Any satement made in conjunction with this submission of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully 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 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 shows the logo for the U.S. Department of Health and 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 three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1990
Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Inc. 100 Interpace Parkway 07054 Parsippany, New Jersey
Re: K991092 EBI SpineLink™ Anterior Trade Name: Cervical Spinal System Regulatory Class: II Product Code: KWQ March 29, 1999 Dated: Received: April 1, 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 The general controls provisions of the Act 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 findinq 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 gener Other qeneral 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,
Witten, Ph.D., M.D. Cel a M. 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™ 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, 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.
Dolly
(Divisior General Restorative Devices 11991092 510(k) Number
Prescription Use
(Per 21 CFR 801.109) X
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.