(30 days)
The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:
- Spondylolisthesis
- Fracture
- Spinal stenosis
- Tumor
- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
The Synthes Anterior Cervical Vertebrae Plate System including the Small Stature Anterior Cervical Vertebrae Plate System consists of plates with expansionhead screws and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants of these systems are manufactured from titanium.
The provided text is a 510(k) premarket notification for the Synthes Anterior CSLP System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and device performance metrics in the way a PMA (Pre-Market Approval) or de novo submission would.
Therefore, the document does not contain the detailed information required to answer many of your questions regarding acceptance criteria, specific study design, sample sizes, expert involvement, or statistical analysis of device performance.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document explicitly states: "Information on the performance of the subject device compared to the performance of previously cleared spinal systems with similar indications has been provided." It does not present specific acceptance criteria or performance metrics for the Synthes Anterior CSLP System itself. The basis of clearance is "substantial equivalence" to predicate devices, implying that its performance is considered equivalent to devices already on the market.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific test set or clinical study data is detailed in the provided documentation for this 510(k) submission. The clearance is based on comparison to predicate devices, which typically involves demonstrating similar material properties, design, and intended use.
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. As no specific clinical test set data is provided, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set data or adjudication method is described.
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 spinal fixation system, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a spinal fixation system and does not involve any algorithms in the manner implied by this question.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth data is presented for this device in the context of clinical performance. The "ground truth" for a 510(k) in this context is often the established safety and effectiveness of the predicate device(s) through their prior marketing.
8. The sample size for the training set
- Not Applicable. As this is a medical implant and not a learnable algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary:
The provided document is a 510(k) Premarket Notification for a spinal fixation system. A 510(k) relies on demonstrating "substantial equivalence" to a predicate device rather than conducting new, extensive clinical trials with pre-defined acceptance criteria and performance metrics. Therefore, the detailed study information, acceptance criteria, and performance data typically associated with a PMA or de novo submission are not present in this document. The "study" referenced is the comparison of the device's design, materials, and indications for use to already cleared predicate devices.
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KO30866 PACE 1/1
Synthes Anterior CSLP System
Summary of Safety and Effectiveness Information 3.0
APR 1 8 2003
SYNTHES (U.S.A.) 1380 Enterprise Drive West Chester, PA 19380 (610) 647-9700 Contact: Jonathan Gilbert 3/18/02
DEVICE: Synthes Spine Anterior CSLP System [formerly known as: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (as part of Synthes Anterior Cervical Vertebrae Plate System, K945700),10/27/97]
DESCRIPTION
The Synthes Anterior Cervical Vertebrae Plate System including the Small Stature Anterior Cervical Vertebrae Plate System consists of plates with expansionhead screws and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants of these systems are manufactured from titanium.
INDICATIONS
The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Tumor
-
- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
CLASSIFICATION:
The classification of the subject device is Class II, as per the Code of Federal Regulations, Title 21, Section 888.3060: Spinal intervertebral body fixation orthosis. The product code is KWQ. The Panel code is 87.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The components of the Synthes Spine Anterior CSLP system are the equivalent to components of previously cleared spinal systems. Information on the performance of the subject device compared to the performance of previously cleared spinal systems with similar indications has been provided.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures facing to the right. The figures are represented by curved lines that suggest movement and connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2003
Mr. Jonathan Gilbert Project Manager, Regulatory Affairs SYNTHES Spine 1380 Enterprise Drive West Chester, Pennsylvania 19380
Re: K030866
Trade Name: Synthes Anterior CSLP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 18, 2003 Received: March 19, 2003
Dear Mr. Gilbert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Mark N. Millkum
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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Synthes Anterior CSLP System
2.0 Indications for Use Statement
Page 1 of 1
510(k) Number (if known): NA
Device Name: Synthes Anterior CSLP System
INDICATIONS
The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Tumor
-
- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the-Counter Use (Per 21 CFR 801.109)
Mark N. Milkersen
General, Restorative id Neurological Devices
(k) Number K 030866
Synthes Spine Company, L. P. CSLP 510(k)
Confidential March 18, 2003
§ 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.