(246 days)
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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),
spondylolisthesis,
trauma (i.e. fractures or dislocations),
tumors.
deformity (defined as kyphosis, lordosis, or scoliosis),
pseudarthrosis.
failed previous fusion,
spinal stenosis
The Osteomed Implantes Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to six). The Osteomed plate incorporates holes or vision ports on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a variety of lengths (8mm - 20mm).
The provided document describes the Osteomed Implantes Anterior Cervical Plate System and its 510(k) submission to the FDA. This document does not contain information about a study proving the device meets specific acceptance criteria related to software algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, or the use of experts for ground truth establishment.
Instead, this document details regulatory information for a medical device (an Anterior Cervical Plate System) and its non-clinical testing for substantial equivalence to predicate devices. The "acceptance criteria" referred to in the document are primarily related to mechanical performance standards for spinal implants, not algorithmic performance.
Here's an analysis based on the available information, addressing what can be answered and clearly stating what is not present:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-clinical Mechanical Testing) | Reported Device Performance |
|---|---|
| Static compression per ASTM F1717 | Results indicate equivalence to predicate devices. |
| Dynamic compression per ASTM F1717 | Results indicate equivalence to predicate devices. |
| Static torsion per ASTM F1717 | Results indicate equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical tests. Typically, these are engineering bench tests, not clinical human-based studies.
- Data Provenance: The tests are non-clinical (bench tests) performed to ASTM F1717 standards. The country of origin of this specific test data is not detailed, but the manufacturer is Osteomed Implantes, LTDA from Brazil.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for mechanical testing is adherence to engineering standards and comparative performance against predicate devices, not expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for clinical or imaging studies where expert consensus is needed.
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:
- No MRMC study was done. The document explicitly states: "No clinical studies were performed." This device is a physical implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is adherence to the mechanical performance requirements and benchmarks set by the ASTM F1717 standard and the performance of the legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable and not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable and not provided. This is not an AI/ML device.
Conclusion based on the provided document:
The Osteomed Implantes Anterior Cervical Plate System underwent non-clinical mechanical testing (static and dynamic compression, static torsion per ASTM F1717) to demonstrate substantial equivalence to predicate devices. The study concluded that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use, and the results of these non-clinical evaluations. No clinical studies were performed, and no information regarding algorithmic performance, human reader studies, or expert-derived ground truth for such studies is present because the device is a physical implant, not a software or AI-based diagnostic tool.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2016
Osteomed Implantes, LTDA % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K151553
Trade/Device Name: Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 5, 2016 Received: January 8, 2016
Dear Mr. Webb:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151553
Device Name Anterior Cervical Plate System
Indications for Use (Describe)
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Prepared | June 5, 2015 |
|---|---|
| Submitted By | Osteomed Implantes, LTDAWashington Luiz Road, km 172Condomínio Conpark - Rua 6, S/NCEP 13501-600Rio Claro - SPBRAZIL(19) 3532-3411 Tele |
| Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net |
| Trade Name | Anterior Cervical Plate System |
| Common Name | anterior cervical plate |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | Cervical Spine Locking Plate (CSLP) - Synthes (K031276/K030866/K000742/K000536/K945700) |
| Additional PredicateDevices | C-Tek MaxAn Anterior Cervical Plate System - Biomet Spine (K080646)UNIPLATE ANTERIOR CERVICAL PLATE, - DePuy (K042544 / K082273 /K100070) |
| Device Description | The Osteomed Implantes Anterior Cervical Plate System is intended for anteriorscrew fixation of the plate to the cervical spine. The fixation construct consists ofa cervical plate that is attached to the vertebral body of the cervical spine withself-tapping bone screws using an anterior approach. Plates are available in avariety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one tosix). The Osteomed plate incorporates holes or vision ports on the longitudinalcenter line for intraoperative visualization and for screw fixation of bone graft.Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and avariety of lengths (8mm - 20mm). |
| Materials | Commercially pure titanium conforming to ASTM F67Titanium alloy (Ti6Al4V) conforming to ASTM F136 |
| SubstantialEquivalence Claimedto Predicate Devices | The Anterior Cervical Plate System is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety, andperformances. |
| Indications for Use | The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis |
| Non-clinical Test Summary | The following analyses were conducted: Static and dynamic compression per ASTM F1717 Static torsion per ASTM F1717 The results of these evaluations indicate that the Anterior Cervical Plate System is equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Osteomed Implantes considers the Anterior Cervical Plate System to be equivalent to the predicate device listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use |
510(k) Summary: Anterior Cervical Plate System
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§ 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.