The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

Device Description

The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with (4) bone screws provided and the accompanying anterior cover plate assembly. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136.

AI/ML Overview

The provided text describes a medical device, the Choice Spine HARRIER-SA™ Lumbar Interbody System, and its FDA 510(k) clearance. This document is a premarket notification for a traditional medical device, not a software as a medical device (SaMD) or AI/ML device that would have performance criteria in terms of accuracy, sensitivity, or specificity. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (as implied by questions about ground truth, expert adjudication, MRMC studies, etc.) is not applicable here.

Instead, the "acceptance criteria" and "study" for this type of device refer to its mechanical and material safety and performance, as demonstrated through non-clinical testing in comparison to predicate devices. The study proves the device meets these criteria by demonstrating substantial equivalence.

Here's an interpretation of the request based on the provided document:

Acceptance Criteria and Study for the Choice Spine HARRIER-SA™ Lumbar Interbody System

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance/Study Conclusion
Material Equivalence: Materials used are comparable to predicates and are biocompatible.	The implant spacer components are made from Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136. These materials are well-established for interbody fusion devices and are similar to predicate devices, ensuring biocompatibility.
Mechanical Performance (Static Compression): Device withstands static compressive forces as per ASTM F2077.	Non-clinical testing, including Static Compression per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Mechanical Performance (Static Compression Shear): Device withstands static compression shear forces as per ASTM F2077.	Non-clinical testing, including Static Compression Shear per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Mechanical Performance (Dynamic Compression): Device withstands dynamic compressive forces as per ASTM F2077.	Non-clinical testing, including Dynamic Compression per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Mechanical Performance (Dynamic Compression Shear): Device withstands dynamic compression shear forces as per ASTM F2077.	Non-clinical testing, including Dynamic Compression Shear per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Expulsion Resistance: Device effectively resists expulsion forces.	Non-clinical testing for Expulsion was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Subsidence Resistance: Device effectively resists subsidence as per ASTM F2267.	Non-clinical testing for Subsidence per ASTM F2267 was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Functional Equivalence: Device's principle of operation, indications for use, stabilization method, and anatomical location are substantially equivalent to legally marketed predicate devices.	The device is deemed "substantially equivalent" to predicate devices (Spine Smith Cynch Spinal System, NuVasive Lumbar Interbody Implants, Choice Spine TOMCAT™ Cervical Spinal System, and Choice Spine TiGer Shark™) in principle of operation, indications for use (L2-S1, DDD with Grade I spondylolisthesis), biocompatibility, manufacturing, stabilization method, sterilization method, anatomic location, and product code. Slight differences in screw number and bone graft type were addressed by mechanical testing to confirm equivalence.
Safety and Effectiveness: The device is as safe and effective as predicate devices when used for its intended purpose.	The overarching conclusion is that "After considering all similarities and differences to the predicate devices, the subject device has shown to be equivalent when compared to the predicate devices in safety, effectiveness, and performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the clearance is based on non-clinical (mechanical) testing and comparison to existing predicate devices, not on a clinical trial with a "test set" of patient data. The "test set" here would refer to the mechanical test specimens.

Sample Size: The document does not specify the exact number of samples used for each non-clinical test (e.g., how many constructs were tested for static compression). This information is typically detailed in the full test reports submitted to the FDA, but not usually summarized in the 510(k) summary.
Data Provenance: Not applicable. These are laboratory tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in this context would refer to the established standards and specifications for mechanical testing (e.g., ASTM standards F2077, F2267). The "experts" involved are those who designed and conducted the mechanical tests according to these standards, typically engineers and biomechanical scientists, not medical professionals establishing diagnostic ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish a consensus "ground truth" for diagnostic purposes. Mechanical testing relies on objective measurements against defined standards, not subjective expert adjudication.

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

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices, especially AI-assisted ones, where human readers interpret medical images. This device is an intervertebral body fusion system, not a diagnostic imaging or AI tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. This question pertains to AI/ML software performance. The device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by validated mechanical testing standards (e.g., ASTM F2077 for intervertebral body fusion devices, ASTM F2267 for subsidence) and material specifications (e.g., ASTM F3001, ASTM F560, ASTM F136). The "truth" is whether the device meets or exceeds the biomechanical requirements and material properties as defined by these industry standards and the performance of predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device undergoing mechanical testing for 510(k) clearance.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth to be established for it.

Summary

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May 16, 2018

Choice Spine, LP Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

Re: K180519

Trade/Device Name: Choice Spine HARRIER-SA™ Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: April 11, 2018 Received: April 12, 2018

Dear Ms. Finch:

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,

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) K180519

Device Name

Choice Spine HARRIER-SA™ Lumbar Interbody 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

Date:Sponsor:	April 9, 2018Choice Spine, LP400 Erin DriveKnoxville, TN 37919
Phone:Fax:Contact Person:	865-246-3333865-246-3334Kim Finch, Manager of Regulatory Affairs
ProposedProprietary TradeName:	Choice Spine HARRIER-SA™ Lumbar Interbody System
Product Class:ClassificationName:	System Class II
	888.3080 - Intervertebral Body Fusion Device
Device ProductCode:	OVD, MAX
	Purpose of Submission: The purpose of this submission is to gain clearance for the new the Choice SpineHARRIER-SA™ Lumbar Interbody System.
Device Description:	The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in varioussizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with(4) bone screws provided and the accompanying anterior cover plate assembly.The implant spacer components are made from two materials:Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTMF3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plateand screws per ASTM F136.
	The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alonedevice intended to be used with four bone screws and the accompanyinganterior cover plate. Supplemental fixation, cleared by the FDA for use in thelumbosacral spine, must be used with implants ≥20°. Supplemental fixationmust also be used whenever fewer than four bone screws are used. Theanterior cover plate must be utilized whenever the device is implanted.
Indications for Use:	The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated forintervertebral body fusion of the lumbar spine, from L2 to S1, in skeletallymature patients who have had six months of non-operative treatment. Thisdevice is intended for use at either one level or two contiguous levels for thetreatment of degenerative disc disease (DDD) with up to Grade Ispondylolisthesis. DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies. Thisdevice is designed to be used with autogenous bone graft and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bone graft.
Materials:	The implant spacer components are made from two materials:1.Invibio PEEK-OPTIMA™ HA Enhanced2.Ti-6Al-4V ELI Titanium per ASTM F3001, Class CTantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws perASTM F136. All implants except for the screws will be provided sterile. Screwswill be provided non-sterile but will be steam sterilized before use.Instruments will be provided non-sterile but will be steam sterilized before use.The instrumentation is made from 455 SS and 17-4 SS, 465 SS per ASTM A564.
Non-Clinical Testing:	Static Compression - Per ASTM F2077Static Compression Shear - Per ASTM F2077Dynamic Compression - Per ASTM F2077Dynamic Compression Shear - Per ASTM F2077ExpulsionSubsidence - per ASTM F2267
SubstantialEquivalence:	The implants included in this submission are equivalent to the Spine SmithCynch Spinal System - Visualif Interbody Fusion Implant System (K102090,primary predicate), NuVasive Lumbar Interbody Implants (K153782, additionalpredicate), Choice Spine TOMCAT™ Cervical Spinal System (K170953, additionalpredicate), and the Choice Spine TiGer Shark™ (K172816, additional predicate).
SubstantialEquivalenceConclusion"	The implants proposed in this submission are similar to the predicate devices in:principle of operation, material, indications for use, biocompatibility,manufacturing and post-processing steps, stabilization method, sterilizationmethod, anatomic location and approach, product code and classification. Theindications for use were compared, the differences include the subject device isdesigned to use four screws for stabilization while the primary predicate utilizestwo and is cleared for use with autograft while the subject device and otherpredicates are intended to be used with autogenenous bone graft and /orallogenic bone graft comprised of cancellous and/or corticocancellous bonegraft.Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™Lumbar Interbody System design is equivalent when compared to the predicatedevices. After considering all similarities and differences to the predicatedevices, the subject device has shown to be equivalent when compared to thepredicate devices in safety, effectiveness, and performance.

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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.