(61 days)
The White Pearl Preferred Angle Anterior Cervical Plate 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 White Pearl Preferred Angle Anterior Cervical Plate consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to provide stabilization of the cervical vertebrae for various indications. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The White Pearl Preferred Angle Anterior Cervical Plate is intended to be removed after solid fusion has occurred.
This document is a 510(k) Pre-Market Notification for a medical device called the "White Pearl Preferred Angle Anterior Cervical Plate." It outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Acceptance Criteria and Reported Device Performance
This document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a novel device with clinical endpoints like sensitivity or specificity. Instead, the acceptance criteria are based on mechanical performance standards to demonstrate that the new device performs as safely and effectively as existing, legally marketed devices.
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (from non-clinical testing) |
|---|---|
| Intended Use: Device should have similar indications for use as predicate devices. | The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine (C2 to T1), an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudarthrosis, failed previous fusion, and spinal stenosis. This matches the general scope and indications often associated with predicate anterior cervical plates. |
| Design: Similar design principles and components (plates, locking caps, bone screws). | Consists of cervical plates, locking caps, bone screws, and instruments. Fixation construct with plates attached to vertebral body using self-tapping/self-drilling bone screws, with options for fixed or variable angle. This aligns with standard anterior cervical plate designs. |
| Materials: Similar biocompatible materials (e.g., titanium alloy). | All implant components are made from Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136, a standard material for such implants. |
| Mechanical Safety and Performance: Device should meet recognized mechanical testing standards. | Static and dynamic compression testing per ASTM F1717 performed. Static torsion testing per ASTM F1717 performed. The results indicated substantial equivalence to predicate devices. |
Study Details:
The provided document describes non-clinical testing to support the substantial equivalence claim.
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Sample Size used for the test set and the data provenance:
- The document does not specify the sample size (number of constructs or units) used for the mechanical "test set." It only mentions the types of tests performed.
- Data provenance is not explicitly stated in terms of country of origin. The tests are described as non-clinical (laboratory-based mechanical testing), not involving patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. Mechanical testing of a medical device does not typically involve expert review to establish "ground truth" in the way clinical studies or diagnostic AI algorithms do. The "ground truth" for mechanical testing is defined by the physical loads and deformation measurements under established ASTM standards (ASTM F1717).
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Adjudication method for the test set:
- This question is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used in clinical studies or for diagnostic image interpretation where there's variability in expert opinion. For mechanical testing, the results are quantitative measurements against predefined standards.
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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 MRMC comparative effectiveness study was done. This document is for a spinal implant, which is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, "human readers" and "AI assistance" are irrelevant in this context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used:
- For the non-clinical mechanical testing, the "ground truth" is established by the definitions and requirements of the ASTM F1717 standard for static and dynamic compression and static torsion testing. This standard specifies how to conduct the tests and how to measure the mechanical properties of the device.
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The sample size for the training set:
- Not applicable. This document describes the testing of a physical medical device. There is no concept of a "training set" as would be used for machine learning.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
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April 26, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osseus Fusion Systems, LLC % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K160522
Trade/Device Name: White Pearl Preferred Angle Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 12, 2016 Received: April 14, 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. J.D. Webb
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 vours.
Mark N. Melkerson -S
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) K160522
Device Name
White Pearl Preferred Angle Anterior Cervical Plate
Indications for Use (Describe)
The White Pearl Preferred Angle Anterior Cervical Plate 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) |
|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: White Pearl Preferred Angle Anterior Cervical Plate
| Date Prepared | February 15, 2016 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC2703 Mockingbird Lane, Suite 102Dallas, TX 75235214-395-0100 Teleemail: rpace@osseus.com |
| Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net |
| Trade Name | White Pearl Preferred Angle Anterior Cervical Plate |
| Common Name | anterior cervical plate |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | ll |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | Zimmer Trinica/Trinica Select Anterior Cervical Plate System (K132012) |
| Additional PredicateDevices | Spinal USA Slimpicity Anterior Cervical Plate System (K060025)Synthes Anterior CSLP System (K000536)DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070)Zimmer Optio-C Anterior Cervical System (K132894) |
| Device Description | The White Pearl Preferred Angle Anterior Cervical Plate consist of cervicalplates, locking caps, bone screws, and the instruments necessary to implant thisspecific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended toprovide stabilization of the cervical vertebrae for various indications. The fixationconstruct consists of a cervical plate that is attached to the vertebral body of thecervical spine with self-tapping and/or self-drilling bone screws using an anteriorapproach. Bone screws are available for fixed angle or variable angleimplantation. The White Pearl Preferred Angle Anterior Cervical Plate isintended to be removed after solid fusion has occurred. |
| Materials | Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 |
| SubstantialEquivalence Claimedto Predicate Devices | The White Pearl Preferred Angle Anterior Cervical Plate is substantiallyequivalent to the predicate devices in terms of intended use, design, materialsused, mechanical safety and performances. |
| The White Pearl Preferred Angle Anterior Cervical Plate is intended for anteriorscrew fixation to the cervical spine. It is to be used in skeletally mature patientsas an adjunct to fusion of the cervical spine (C2 to T1). The system is indicatedfor use in the temporary stabilization of the anterior spine during thedevelopment of cervical spinal fusion in patients with: | |
| Indications for Use | degenerative disc disease (as defined by neck pain of discogenic originwith degeneration of the disc confirmed by patient history andradiographic studies) spondylolisthesis trauma (i.e. fractures or dislocations) tumors deformity (defined as kyphosis, lordosis, or scoliosis) pseudarthrosis failed previous fusion spinal stenosis |
| Non-clinical TestSummary | The following analyses were conducted:Static and dynamic compression testing per ASTM F1717 Static torsion testing per ASTM F1717 The results of these evaluations indicate that the White Pearl Preferred AngleAnterior Cervical Plate is substantially equivalent to the predicate devices. |
| Clinical TestSummary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | The White Pearl Preferred Angle Anterior Cervical Plate is substantiallyequivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation,technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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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.