(191 days)
The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.
The Deltaloc Anterior Cervical Plate System consists of plates and screws that are used for attachment to the anterior cervical spine. Plates are offered in a variety of sizes with varying numbers of screw holes to accommodate single to quadruple level fusions. Plates are shaped with both radial and lordotic curvature and contain a deformable tab at each screw hole to capture the screws to the plate, preventing screw digression. Screws are offered in two diameters and four lengths per diameter. All screws are also available so that their angle relative to the plate is fixed or variable.
The plates of the Deltaloc Anterior Cervical Plate System are manufactured from commercially pure titanium and the screws are manufactured from titanium alloy (Ti-6Al-4V).
This document is not a study; it is a 510(k) premarket notification for the Deltaloc Anterior Cervical Plate System. A 510(k) notification aims to establish substantial equivalence to a predicate device already on the market, rather than proving device performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
This document, being a 510(k) notification, does not provide specific performance criteria or a table comparing them to reported device performance. It focuses on demonstrating substantial equivalence to a predicate device.
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 premarket notification for a medical device (cervical plate system), not a study involving a test set of data.
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. This is a premarket notification for a medical device (cervical plate system), not a study involving expert-established ground truth.
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 device is a physical implant (cervical plate system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Information that is available from the document:
- Device Name: Deltaloc Anterior Cervical Plate System
- Manufacturer: Alphatec Manufacturing, Inc.
- Intended Use/Indications: For use in the anterior cervical spine (C2-C7) in patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.
- Predicate Device: Synthes CSLP (Cervical Spine Locking Plate) System
- Basis for Approval: Substantial equivalence to the predicate device in design, function, materials used, and indications for use.
- Materials: Plates from commercially pure titanium, screws from titanium alloy (Ti-6Al-4V).
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APR 2 6 2000
Manufacturer Identification
Premarket Notification Interior Cervical Plate System hater Manufacturing, Inc.
510(k) Summary
510(k) Number K993513
Alphatec Manufacturing, Inc. Submitted By: 42-160 State Street Palm Desert, CA 92211 phone: (760) 779-8250 (760) 776-5527 fax: Contact Person: Jason Blain Manager of Product Development Date Summary Prepared: January 24, 2000 Device Identification Deltaloc Anterior Cervical Plate System Proprietary Name: Spinal Intervertebral Body Fixation Orthosis Common Name: 21 CFR 888.3060: Appliance, Fixation, Spinal, Classification: Intervertebral Body
Device Description
The Deltaloc Anterior Cervical Plate System consists of plates and screws that are used for attachment to the anterior cervical spine. Plates are offered in a variety of sizes with varying numbers of screw holes to accommodate single to quadruple level fusions. Plates are shaped with both radial and lordotic curvature and contain a deformable tab at each screw hole to capture the screws to the plate, preventing screw digression. Screws are offered in two diameters and four lengths per diameter. All screws are also available so that their angle relative to the plate is fixed or variable.
The plates of the Deltaloc Anterior Cervical Plate System are manufactured from commercially pure titanium and the screws are manufactured from titanium alloy (Ti-6Al-4V).
Intended Use of the Device
The Deltaloc Anterior Cervical Plate System is indicated for: use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with
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Image /page/1/Picture/0 description: The image shows the title "Premarket Notification" followed by "Deltaloc Anterior Cervical Plate System" and "Alphatec Manufacturing, Inc.". There is also a logo on the left side of the image that says "Alphatec Manufacturing, Inc.". The image is a document that appears to be a premarket notification for a cervical plate system manufactured by Alphatec Manufacturing, Inc.
degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.
Substantial Equivalence
The Deltaloc Anterior Cervical Plate System is substantially equivalent to the Synthes CSLP (Cervical Spine Locking Plate) System. The Deltaloc Anterior Cervical Plate System is similar to the listed predicate device in design, function, materials used, and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is a stylized symbol that resembles a bird or a person with outstretched arms. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2000
Mr. Jason Blain Alphatec Manufacturing Inc 42-160 State Street Palm Desert, California 92211
Re: K993513
Trade Name: Deltaloc Anterior Cervical Plate System Regulatory Class: II Product Code: KWQ Dated: January 24, 2000 Received: January 27, 2000
Dear Mr. Blain:
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.
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Page 2 - Mr. Jason Blain
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. Lochner
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
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Intended Uses/Indications
510(k) Number: K993513
Device Name: Detaloc Anterior Cervical Plate System
Indications for Use:
The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.
Dumas R. Lochner.
510(k) Number
§ 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.