(349 days)
The Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. 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 with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.
The Window Cervical Plate System is a set of implants designed to be implanted via an anterior approach to the cervical spine. The system includes various plates and screws manufactured from Titanium. The material used in the manufacture of the components in the Window Cervical System meets ASTM F136 for Ti 6A1-4VELI.
This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, and comparative effectiveness studies is mostly not applicable in the context of an AI/ML device.
However, I can extract the relevant information within the context of a medical device submission:
1. A table of acceptance criteria and the reported device performance
The submission does not present specific acceptance criteria in the form of performance metrics for the "Window Cervical Dynamic Plate System." Instead, the key "acceptance criteria" here are demonstrating substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Product Components Equivalence | Window Cervical Plate Spinal System: Plates of various lengths, 4mm screws, 4.3mm revision screws |
| ORION Cervical Plate System (Predicate): Plates of various lengths, 4mm screws, 4.35mm revision screws | |
| Indications for Use Equivalence | Window Cervical Plate Spinal System: Anterior interbody screw fixation of the cervical spine for various conditions (degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, failed fusions) |
| ORION Cervical Plate System (Predicate): Identical | |
| Materials Equivalence | Window Cervical Plate Spinal System: Titanium (meeting ASTM F136 for Ti 6A1-4VELI) |
| ORION Cervical Plate System (Predicate): Titanium | |
| Product Labeling Equivalence | Window Cervical Plate Spinal System: Instructions for use and box labeling including all necessary warning statements |
| ORION Cervical Plate System (Predicate): Instructions for use and box labeling including all necessary warning statements | |
| Packaging/Sterilization Equivalence | Window Cervical Plate Spinal System: Non-sterile, single use only |
| ORION Cervical Plate System (Predicate): Non-sterile, single use only | |
| Mechanical Testing Equivalence | Testing completed as per ASTM F1717 (results included in Appendix 1 of the submission, but not detailed in this excerpt) to demonstrate equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission describes a medical device (surgical implant), not an AI algorithm evaluated on a 'test set' of data in the typical sense. Therefore, concepts like sample size for a test set, data provenance (country, retrospective/prospective), and ground truth are not directly applicable in the way they would be for an AI/ML development.
The "testing" mentioned refers to mechanical and material testing (e.g., ASTM F1717) of the physical device or its components to ensure it meets performance standards and can be considered equivalent to the predicate. The "sample size" for such tests would refer to the number of devices or components tested, not a dataset of patient information. This information is mentioned as being in "Appendix 1" but not detailed in the provided text.
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)
This is not applicable to this medical device submission. Ground truth, in the context of AI, refers to expert-labeled data. For a physical medical implant, the "truth" is established by engineering standards, material properties, and clinical outcomes over time (post-market surveillance), not by expert labeling of a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements among human reviewers labeling data for AI/ML training or testing. This process is not part of a 510(k) submission for a physical device.
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. MRMC studies are used to evaluate diagnostic imaging devices or AI tools that assist human readers. This device is a surgical implant; it does not involve human "readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this device revolves around its physical properties, biocompatibility, and mechanical performance, established through engineering tests and adherence to standards (like ASTM F136, ASTM F1717). Its clinical safety and effectiveness are inferred from its substantial equivalence to a predicate device with a history of safe use and similar design/materials.
8. The sample size for the training set
Not applicable. Training sets are used for AI/ML algorithms. This is a physical medical device.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
K993α6i
Section 7 - 510(k) Summary of Safety and Effectiveness
| 7.1Statement | This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and CFR 807.92 |
|---|---|
| 7.2Submitter | Advanced Spine Technology, Inc.3645 Grand Avenue, Suite 304Oakland, CA. 94610 |
| 7.3CompanyContact | Susan FinneranQA/ RA Manager (Endius, Inc.)508-643-0983Acting as a consultant to Advanced Spine Technology, Inc. |
| 7.4Device Name | Proprietary Name:Window Cervical Dynamic Plate SystemCommon Name:Anterior Cervical Plating SystemClassification Name:Spinal Intervertebral Body Fixation Orthosis.(KWO) |
| 7.5PredicateLegallyMarketedDevices | ORION Anterior Cervical Plate System manufactured by Sofamor Danek(Memphis, TN.) |
|---|---|
| ---------------------------------------------------- | -------------------------------------------------------------------------------------- |
{1}------------------------------------------------
| 7.6DeviceDescription | The Window Cervical Plate System is a set of implants designed to beimplanted via an anterior approach to the cervical spine. The system includesvarious plates and screws manufactured from Titanium. The material used inthe manufacture of the components in the Window Cervical System meetsASTM F136 for Ti 6A1-4VELI. |
|---|---|
| 7.7DeviceIndications andIntended use | The Window Cervical Plate System is intended for anterior interbody screwfixation of the cervical spine. The system is indicated for use in thetemporary stabilization of the anterior spine during the development ofcervical spinal fusions in patients with degenerative disc disease (as defined |
cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine
7.8 The Window Cervical Plate Spinal System is substantially equivalent to the Substantial ORION Cervical Spinal System. Equivalence Following is a table that describes the features of the new and the predicate systems that indicate substantial equivalence. Testing was also completed as per ASTM F1717 in order to demonstrate equivalence. The results of testing are included in appendix 1 of the submission.
{2}------------------------------------------------
7.9 Table of Substantial Equivalence
:
| Device Name | The Window Cervical Plate Spinal System | ORION Cervical Plate System |
|---|---|---|
| ProductComponents | Plates of various lengths, 4mm screws, 4.3mm revision screws | Plates of various lengths, 4mm screws, 4.35mm revision screws |
| Indications for Use | See above | Identical |
| Materials | Titanium | Titanium |
| Product Labeling | Instructions for use and box labeling including all of the necessary warning statements | Instructions for use and box labeling including all of the necessary warning statements |
| Packaging/Sterilization | Non-sterile, single use only | Non-sterile, single use only |
Applicant Susan Jinn
Date 12/13/99
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above three wavy lines.
Public Health Service
JUN - 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gordon Tao President of Advanced Spine Technology Incorporated C/O Ms. Susan Finneran Regulatory Affairs Consultant, AST QA/RA Manager Endius Incorporated 23 West Bacon Street Plainville, Massachusetts 02762
Re: K993066
Trade Name: Window Cervical Dynamic Plate System Regulatory Class: II Product Code: KWQ Dated: March 23, 2000 Received: April 3, 2000
Dear Mr. Tao:
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 control provisions of the Act. The general control 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.
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.
{4}------------------------------------------------
Page 2 - Mr. Gordon Tao
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,
Dune R. Kirchner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): K993066
Device Name: Window Cervical Dynamic Plate System
Indications for Use:
The Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. 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 with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Posted July 1, 1998)
(Optional Format 3-10-98)
Dame R. Lachner
(Division Sign-Off) Division of General Restorative Devices 510(k) Number 199306
§ 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.