(27 days)
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
The Zavation Buttress Plate System consists of screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
The provided text is a 510(k) summary for the Zavation Buttress Plate System. This document does NOT contain information about acceptance criteria for a medical device's performance as typically assessed in clinical studies, nor does it detail a study proving such performance against specific metrics.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for Class II medical devices in the United States. The "performance data" mentioned refers to biomechanical testing to show the device itself is safe and effective in its engineering properties, not AI or a diagnostic algorithm's accuracy.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
Here's what can be gathered, reinterpreting "acceptance criteria" and "device performance" in the context of this 510(k) for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (in context of 510(k)) | Reported Device Performance (as demonstrated by tests) |
|---|---|
| Biomechanical performance similar to predicate devices for spinal fixation. | Biomechanical testing, including static and fatigue cantilever beam loading, was conducted. |
| Made from appropriate materials for medical implants. | Components manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| Basic design, sizes, and intended use are comparable to predicate devices. | Possesses the same technological characteristics as predicates: basic design (plate designed system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not provided. The document refers to biomechanical testing, not an algorithmic test set or patient data.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information pertains to studies validating diagnostic or AI-driven devices, not the biomechanical testing of an implantable medical device.
4. Adjudication method 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
- No, an MRMC study was not done, and this type of study is not relevant for the type of device (spinal buttress plate) described.
6. 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.
7. The type of ground truth used
- Ground truth concept (for biomechanical testing): The "ground truth" for this type of device would be established engineering standards (e.g., ASTM F136 for material, industry standards for static and fatigue loading) and the performance characteristics of the predicate devices. The device's performance is compared to these established benchmarks to demonstrate safety and effectiveness.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of AI or machine learning.
9. How the ground truth for the training set was established
- Not applicable.
In summary: This document is a regulatory submission for a physical medical device (a buttress plate system for spinal fusion). The "study" mentioned is biomechanical testing to demonstrate that the device functions as intended and is comparable to existing devices, satisfying the requirements for 510(k) submission for substantial equivalence. It does not provide information related to the performance evaluation of a diagnostic algorithm or AI-powered device, which is what your questions are primarily structured for.
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March 27, 2018
Zavation Medical Products LLC Matt Jones Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K180537
Trade/Device Name: Zavation Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 27, 2018 Received: February 28, 2018
Dear Matt Jones:
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 of medical device-related adverse events) (21 CFR 803); 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K180537
Device Name Zavation Buttress Plate System
Indications for Use (Describe)
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
| 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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510K Summary
| Date: | February 27, 2018 |
|---|---|
| Submitter: | Zavation Medical Products LLC220 Lakeland PkwyFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302 |
| Contact Person: | Matt Jones |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Buttress Plate System |
| Common name: | Anterior Buttress Plate |
| Classification regulation: | 888.3060 |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | KWQ |
Device Description:
The Zavation Buttress Plate System consists of screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Intended Use:
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
Materials:
The Zavation Buttress Plate System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
Primary Predicate Device:
K081770 Black Widow Anterior Buttress Plate System [Spinal Elements]
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Additional Predicate Devices:
K061482 Altes Anterior Buttress Plating System [Exactech Spine] K112533 Zavation Cervical Plate System [Zavation]
Technological Characteristics:
The Zavation Buttress Plate System possesses the same technological characteristics as the predicates. These include: basic design (plate designed system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use (as described above).
Performance Data:
Biomechanical testing, including static and fatigue cantilever beam loading were conducted.
Conclusion:
The Zavation Buttress Plate System is substantially equivalent to the devices referenced above.
N/A