(69 days)
The Synthes Posterior Universal Spinal System devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Synthes Posterior Universal Spinal System consists of stainless steel or titanium components and consists of rods, hooks, side-opening screws with collar and nut (including he subject 9mm diameter side opening screw), variable axis screws with rod and screw connector, collar, locking ring and nut, a trans-connector system, open and closed transverse bars, parallel connectors. Schanz screws, clamp with posterior nut and associated manual surgical instruments.
The provided text is a summary of safety and effectiveness information for the Synthes Posterior Universal Spinal System and the FDA's response to its 510(k) premarket notification. It describes the device, its intended use, and the FDA's determination of substantial equivalence.
However, a critical review of the provided text reveals that it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document states: "This system is substantially equivalent to previously cleared Synthes spinal systems and is supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation." This implies that testing was performed, but the details of that testing, including acceptance criteria and results, are not present in the provided excerpts.
Without a detailed study report, it's impossible to completely fill out the requested table and answer all questions. Based solely on the information provided, here's what can be inferred or stated about the lack of information:
Acceptance Criteria and Device Performance
The provided text does not explicitly state acceptance criteria or report specific device performance metrics in a quantifiable manner. It broadly states that the system is "supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation" and is "substantially equivalent to previously cleared Synthes spinal systems."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., specific thresholds for strength, durability, biocompatibility) | Reported Device Performance (e.g., numerical results from mechanical tests, clinical outcomes) |
|---|---|
| [Not specified in the provided text] | [Not specified in the provided text] The document only generally states that testing "satisfies the requirements" for its intended use and that the device is "substantially equivalent" to predicate devices. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "testing," but provides no details on the sample size of any test sets. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.
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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 / Not specified. The document does not describe any studies involving human experts establishing ground truth for a test set. The evaluation seems to be based on engineering tests and comparison to predicate devices, rather than clinical efficacy studies in the format often seen for AI/diagnostic devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. No information is provided about adjudications for a test set.
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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:
- No. This is a medical device (spinal implant system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described for this type of product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical spinal implant system, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the provided text. For a spinal implant, "ground truth" would typically relate to biomechanical performance (e.g., stiffness, fatigue life, pull-out strength based on industry standards) or an assessment of successful fusion in a clinical setting (outcomes data). The document refers to "testing which satisfies the requirements," implying a comparison against established standards or predicate device performance.
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The sample size for the training set:
- Not applicable/Not specified. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is. If "training set" refers to data used to inform the design, it's not detailed in the provided text.
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How the ground truth for the training set was established:
- Not applicable/Not specified. As above, the concept of a "training set" is not relevant in the context of this physical medical device.
Conclusion:
The provided document (K983530) is a 510(k) summary for a spinal implant system. Its primary purpose is to demonstrate substantial equivalence to legally marketed predicate devices, rather than to detail a comprehensive study with acceptance criteria, performance metrics, and rigorous statistical analysis in the way one might expect for a novel diagnostic or AI device. The text indicates that testing was done to satisfy requirements for posterior thoracolumbar and sacral fixation, but the specifics of that testing (methodology, acceptance criteria, results, sample sizes, etc.) are not included in this summary.
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Synthes Posterior Universal Spine System Premarket Notification ( K983530 ) Additional Information
Summary of Safety and Effectiveness Information DEC 1 6 1998 [510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Jonathan M. Gilbert 12/09/98
Device: Synthes Posterior Universal Spinal System consists of stainless steel or titanium components and consists of rods, hooks, side-opening screws with collar and nut (including he subject 9mm diameter side opening screw), variable axis screws with rod and screw connector, collar, locking ring and nut, a trans-connector system, open and closed transverse bars, parallel connectors. Schanz screws, clamp with posterior nut and associated manual surgical instruments.
This system is substantially equivalent to previously cleared Synthes spinal systems and is supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation.
When used as a posterior pedicle screw fixation system, the Synthes Posterior Universal Spinal System devices are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Synthes Posterior Universal Spinal System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L - S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system, Synthes Posterior Universal Spinal System devices are intended for scoliotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine. In addition, when used with the 3.5mm / 6.0mm parallel connector, the Synthes Posterior Universal Spinal System can be linked to the Posterior Cervical/Thoracic Hook/Rod System.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1998
Mr. Jonathan M. Gilbert Senior Regulatory Affairs Associate Synthes Spine Post Office Box 0548 1690 Russell Road Paoli. Pennsylvania 19301
Re: K983530
Synthes Posterior Universal Spinal System - additional components Regulatory Class: II Product Codes: MNI. KWP. and MNH Dated: October 7, 1998 Received: October 8, 1998
Dear Mr. Gilbert:
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 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). 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 requirements, as set forth in the Quality System Regulation (OS) 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. Jonathan M. Gilbert
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" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Synthes Posterior Universal Spine System Premarket Notification
Page 1 of 1
510(k) Number (if known): -NA-K983530
Device Name: Synthes Posterior Universal Spinal System
Indications for Use:
The Synthes Posterior Universal Spinal System devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
| Over-the-Counter Use | ____________________ (Per 21 CFR 801.109) |
|---|---|
| ---------------------- | ------------------------------------------- |
Signature
Wiston of General Restorative I 510(k) Number
Premarket Notification
Synthes Spine RA01
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.