The LEGEND Spine STYLO Interbody Fusion Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). LEGEND Spine STYLO Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.

LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The Legend Spine Technologies STYLO Interbody Fusion Device is an Interbody Fusion Device that has a hollow chamber to permit packing with autologous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine Technologies STYLO interbody implants are made from either PEEK radiolucent material with embedded tantalum x-ray markers (ASTM F2026 and ASTM F560) or titanium alloy conforming to ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the STYLO Interbody Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices through performance testing and does not describe a study involving an AI/CADe/CADx device or clinical performance criteria related to diagnostic accuracy.

Therefore, many of the requested categories for AI/CADe/CADx studies are not applicable to this document. The information available pertains to the mechanical and material performance of a physical implant device.

Here's the information that can be extracted relevant to the "acceptance criteria" and "study" described, interpreted within the context of a medical implant device's 510(k) submission:

Acceptance Criteria and Device Performance (for the STYLO Interbody Fusion Device - an implant)

Acceptance Criteria (Performance Testing Standards)	Reported Device Performance
Static axial compression (per ASTM F2077-14)	Meets or exceeds performance of predicate devices
Dynamic axial compression (per ASTM F2077-14)	Meets or exceeds performance of predicate devices
Static compression shear (per ASTM F2077-14)	Meets or exceeds performance of predicate devices
Dynamic compression shear (per ASTM F2077-14)	Meets or exceeds performance of predicate devices
Expulsion testing (per ASTM F2077-14 and ASTM F2267-04)	Meets or exceeds performance of predicate devices
Subsidence testing (per ASTM F2077-14 and ASTM F2267-04)	Meets or exceeds performance of predicate devices
Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007	Device demonstrates substantial equivalence to predicate devices

As this document describes an implantable medical device (STYLO Interbody Fusion Device) and not an AI/CADe/CADx algorithm, the following points are not applicable and cannot be found in the provided text:

Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to mechanical testing of physical device samples, not a dataset of patient cases for algorithm evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant device's mechanical testing is based on engineering specifications and physical measurements, not expert clinical interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance testing consists of predefined mechanical performance standards (e.g., load limits, displacement tolerances) established by ASTM standards and FDA guidance.
The sample size for the training set: Not applicable. There is no AI model to be trained.
How the ground truth for the training set was established: Not applicable.

Summary of what's provided related to the study:

The study involved Performance Testing of the STYLO Interbody Fusion Device.

Type of Study: Mechanical and material performance testing.
Standards Used:
- ASTM F2077-14 (Standard Test Methods for Intervertebral Body Fusion Devices)
- ASTM F2267-04 (Standard Test Method for Determining the Rate of Frictional Wear of Intervertebral Body Fusion Devices) - Note: The document lists F2267-04, but F2077-14 is more directly relevant to expulsion and subsidence.
- Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (June 12, 2007)
Conclusion: The device meets or exceeds the performance of predicate devices, demonstrating substantial equivalence.

Summary

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May 3, 2018

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.

Legend Spine Technologies Christine Scifert Exec. VP MRC/X, LLC 6075 Poplar Avenue Memphis, Tennessee 38119

Re: K180071

Trade/Device Name: STYLO Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 2, 2018 Received: April 3, 2018

Dear Ms. Scifert:

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.

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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,

Katherine D. Kavlock -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) K180071

Device Name STYLO Interbody Fusion Device

Indications for Use (Describe)

LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

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

STYLO Interbody Fusion Device April 27, 2018

Company:	Legend Spine Technologies1803 Apple Tree LaneBethlehem, PA 18015
Primary Contact:	Christine ScifertPhone: 901-831-8053
Company Contact:	Gwendolyn DeBoerPhone: 610-366-0077contact@legendspine.net
Trade Name:	STYLO Interbody Fusion Device
Common Name:	Intervertebral Fusion Device with Bone Graft Lumbar
Classification:	II
Classification Name:	Intervertebral Body Fusion Device
Regulation Number:	888.3080
Panel:	87-Orthopedic
Product Code(s):	MAX

Device Description: The Legend Spine Technologies STYLO Interbody Fusion Device is an Interbody Fusion Device that has a hollow chamber to permit packing with autologous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine Technologies STYLO interbody implants are made from either PEEK radiolucent material with embedded tantalum x-ray markers (ASTM F2026 and ASTM F560) or titanium alloy conforming to ASTM F136.

Indications for Use: The LEGEND Spine STYLO Interbody Fusion Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). LEGEND Spine STYLO

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Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.

LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:

Primary Predicate:

Medtronic CAPSTONE® CONTROL Spinal System (K171107) .
Secondary Predicates:
Medtronic CAPSTONE® PEEK Spinal System (K133650)
Camber Spine Technologies, TLS 5.0 Interbody Cage (K121254) .

The subject STYLO Interbody Fusion Device is made from PEEK/Tantalum and Titanium Alloy have demonstrated to be substantially equivalent to the previously cleared devices cleared under K171107. K133650, and K121254 as the products are similar in indications, materials and geometry.

Performance Testing: Static and dynamic axial compression, static and dynamic compression shear, expulsion, and subsidence testing were completed for the STYLO Interbody Fusion Device according to ASTM F2077-14, ASTM F2267-04, and the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.

Conclusion

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.