The Kestrel™ Buttress Plate System is indicated for use to stabilize the allograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, or anterolateral spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Description

The Innovasis Kestrel™ Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion or IBFD expulsion. The Kestrel Buttress Plate System consists of plates and bone screws. The Kestrel System is also intended to provide stabilization and augment development of a solid spinal fusion. The Kestrel Buttress Plate System fixates to the anterior portion of the lumbar vertebral body. The construct may be employed alone or with other anterior, or anterolateral spinal systems made of compatible materials.

AI/ML Overview

The provided text describes a medical device, the Kestrel™ Buttress Plate System, and its clearance process with the FDA. However, it does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria for software or AI-driven devices.

The document is a 510(k) premarket notification for a Class II medical device, which is a spinal intervertebral body fixation orthosis. This type of device is a physical implant made of materials like Titanium, and its performance is evaluated through non-clinical performance testing, primarily mechanical tests.

Therefore, the following information cannot be extracted from the provided text:

Table of acceptance criteria and reported device performance: This document does not detail specific acceptance criteria or performance metrics related to software or AI. It mentions "Performance Data: (Non-clinical)—Performance testing includes static and dynamic cantilever bend, torque to failure and axial pullout." but does not provide the criteria or results.
Sample size for the test set and data provenance: Not applicable, as this is for mechanical testing, not a dataset for software.
Number of experts used to establish ground truth and their qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only without human-in-the-loop performance): Not applicable.
Type of ground truth used: For physical devices, ground truth is typically engineering specifications and physical measurements, not expert consensus or pathology on a dataset.
Sample size for the training set: Not applicable, as there is no mention of an algorithm or AI model being trained.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of a physical medical implant (Kestrel™ Buttress Plate System) through substantial equivalence to a predicate device, based on mechanical performance testing, not a software or AI-driven medical device requiring the type of data requested in the prompt.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Innovasis, Inc. Mr. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K181063

Trade/Device Name: Kestrel™ Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 21, 2018 Received: June 22, 2018

Dear Mr. McCarty:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

July 13, 2018

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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 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,

Brent Showalter -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) K181063

Device Name Kestrel™ Buttress Plate System

Indications for Use (Describe)

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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510(k) Summary

Kestrel™ Buttress Plate System

Company: Innovasis, Inc. 614 E. 3900 South Salt Lake City, UT 84107

Marshall C. McCarty Contact: Phone: (801) 261-2236 mmccarty@innovasis.com
Kestrel™ Buttress Plate System Trade Name:
Common Name: Buttress Plate System
Classification: Regulation No.: 21CFR 888.3060 Class II Product Code: KWQ Review Panel: Orthopedic
Predicate Device: K092659 - Precision Spine RCS Anterior Buttress Plate System This predicate has not been subject to a design-related recall.
Device Description: The Innovasis Kestrel™ Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion or IBFD expulsion. The Kestrel Buttress Plate System consists of plates and bone screws. The Kestrel System is also intended to provide stabilization and augment development of a solid spinal fusion. The Kestrel Buttress Plate System fixates to the anterior portion of the lumbar vertebral body. The construct may be employed alone or with other anterior, or anterolateral spinal systems made of compatible materials.
Performance Data: (Non-clinical)—Performance testing includes static and dynamic cantilever bend, torque to failure and axial pullout.
Materials: Titanium 6 Al 4V ELI per ASTM F136.
The Innovasis Kestrel™ Buttress Plate System is intended for use Intended Use: in the lumbar spine (L1-S1). Users of these products are limited to physicians trained in

orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

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Indications for Use: The Kestrel™ Buttress Plate System is indicated for use to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, or anterolateral spinal systems made of compatible materials. This device is not intended for load bearing applications.

Basis for Substantial Equivalence:

The KestreI™ Buttress Plate System has been subjected to risk analysis, engineering analysis and testing to recognized standards and the worst-case size has been demonstrated to be substantially equivalent to the predicate device, K092659.

The technological characteristics were found to be substantially equivalent in terms of design, sizes, materials (biocompatibility profile and processing), and mechanical strength.

Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the leqally marketed predicate device.

Regulation Number and Section

§ 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.