The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Device Description

The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).

AI/ML Overview

The provided document is a 510(k) premarket notification for the Choice Spine Laminoplasty™ Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven device.

Instead, for a medical device like a spinal fixation system, "acceptance criteria" are generally met through a combination of:

Design Specifications and Material Compliance: Ensuring the device is manufactured from medical-grade materials to specific dimensions and tolerances.
Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
Mechanical Performance Testing: Evaluating the device's strength, durability, and resistance to various forces it might experience in vivo.
Sterilization Validation: Ensuring the device can be sterilized effectively without compromising its integrity.
Clinical Performance (often through substantial equivalence): Demonstrating that the device performs as intended and is as safe and effective as legally marketed predicate devices.

The document primarily focuses on the Substantial Equivalence claim, which is the cornerstone for 510(k) clearance.

Here's an analysis based on the provided text, addressing your points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are derived from recognized standards and comparative performance to predicates, rather than a specific set of diagnostic metrics.

Acceptance Criteria Category	Specific Criteria (Inferred from document/typical practice for device)	Reported Device Performance (from document)
Mechanical Performance	Static and Dynamic 4-Point Bending (per ASTM F2193)	Testing conducted: "Static and Dynamic 4 Point Bend - Per ASTM F2193" (Implies compliance, otherwise equivalence claim would be challenged)
	Axial Screw Pull-out Strength (per ASTM F543)	Testing conducted: "Axial screw pull-out test - Per ASTM F543" (Implies compliance, otherwise equivalence claim would be challenged)
Material Biocompatibility	Use of medical-grade materials, non-toxic, non-allergenic	Implants: "medical grade Titanium alloy Ti-6Al-4V ELI per ASTM F136."Instrumentation: "medical grade 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209)." (Compliance with these standards implies biocompatibility)
Sterilization Efficacy	Device must be capable of effective sterilization	(Not explicitly mentioned in the provided text, but a mandatory part of medical device clearance)
Design & Functionality	Capable of holding/buttressing allograft/autograft to prevent expulsion/impingement in C3-T3 spine.	"The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord." (This is the intended function, implicitly met through design and testing supportive of substantial equivalence).
Equivalence to Predicates	Similar in design, materials, indications for use, intended use, classification, and performance to predicate devices.	"The Choice Spine Laminoplasty Fixation System is similar in design, materials and performance to the currently marketed predicates." The document explicitly states the "device is substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

For a spinal fixation system seeking 510(k) clearance, the "test set" primarily refers to the physical devices (prototypes or production samples) subjected to mechanical and material testing, not a dataset of patient images or outcomes.

Sample Size for Mechanical Testing: Not explicitly stated in the document. These tests (ASTM F2193, ASTM F543) typically require a specific number of samples (e.g., n=5 or n=6) to establish statistical significance for material properties and device performance.
Data Provenance: The mechanical test data would be generated in a lab setting, typically by the manufacturer or a contract testing facility, specifically for this device design. It's not "retrospective or prospective" in the sense of clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of medical device submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where subjective human interpretation is being evaluated or augmented. For a spinal implant, mechanical tests use objective physical measurements against established standards, and "ground truth" for clinical safety and effectiveness is largely inferred from substantial equivalence to devices with a known clinical history.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies or when interpreting diagnostic images to resolve discrepancies among expert readers and establish a reference standard. For mechanical testing, the results are quantitative measures from instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted or is not detailed in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices or AI tools to assess reader performance with and without AI assistance. This device is a physical implant, not a diagnostic tool.

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

Not Applicable. This device is a physical spinal implant, not an algorithm or AI product. Its performance is evaluated through mechanical testing and comparison to predicate devices, not algorithm-only performance.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily established through:

Recognized Standards: Specific ASTM standards (F2193, F543) define the methodologies and expected performance characteristics for spinal fixation devices. Compliance with these standards forms a "physical ground truth."
Predicate Device Performance: The established safety and effectiveness of the identified predicate devices (DePuy Mountaineer, Synthes Arch Fixation System, Medtronic CENTERPIECE Plate Fixation System, Spectrum Spine Laminoplasty Plating System) serve as a de-facto "clinical ground truth" for substantial equivalence. The new device is accepted if it performs similarly or better in mechanical tests and has similar indications and materials.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for a hardware device, no ground truth needed to be established for it.

Summary

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January 19, 2018

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

Re: K173215

Trade/Device Name: Choice Spine Laminoplasty™ Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: October 27, 2017 Received: October 30, 2017

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 (QS) regulation (21 CFR Part 820);

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Page 2 - Ms. Kim Finch

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

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 mediation-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,

Ronald P. Jean -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) K173215

Device Name

Choice Spine LaminoplastyTM Fixation System

Indications for Use (Describe)

Choice Spine LaminoplastyTM Fixation System:

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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7. 510(k) Summary

Date:Sponsor:Phone:Fax:Contact Person:ProposedProprietary TradeName:Product Class:	Sept 25, 2017Choice Spine, LP400 Erin DriveKnoxville, TN 37919865-246-3333865-246-3334Kim Finch, Director of Regulatory AffairsChoice Spine Laminoplasty™ FixationSystemClass II
Classification Name:	Choice Spine Laminoplasty™ Fixation System888.3050 - Spinal Interlaminal Fixation Orthosis●
Device ProductCode:	Choice Spine Laminoplasty™ Fixation SystemNQW●
Purpose of Submission:	The purpose of this submission is to gain clearance for the new ChoiceSpine Laminoplasty™ Fixation System.
Device Description:	The proposed Choice Spine Laminoplasty Fixation System is an implantsystem that consists of various plates and screw configurations.
	The proposed plates are available in various configurations to addresssurgeon and patient needs as necessary. The proposed plate devicescome preformed with holes for bone screws. The plate offered can beaffixed to allograft or autograft material and secured with a bone screwfrom the system. A hinge plate is provided when additional stabilizationis necessary. Screws are used to attach the plates to bone and areavailable in a variety of lengths and diameters to fit patient anatomy.The system components are made from medical grade Titanium AlloyTi-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564),and 6061 T6 Aluminum (ASTM B221 and B209).
Indications for Use:	The Choice Spine Laminoplasty Fixation System is intended for use inthe lower cervical and upper thoracic spine (C3 to T3) in laminoplastyprocedures. The Choice Spine Laminoplasty Fixation System is used tohold or buttress the allograft or autograft material in place in order toprevent the graft material from expulsion or impinging the spinal cord.
Non-Clinical Testing:	Static and Dynamic 4 Point Bend - Per ASTM F2193Axial screw pull-out test - Per ASTM F543
Materials:	The implants are made of medical grade Titanium alloy Ti-6Al-4V ELI perASTM F136. Instrumentation is made of medical grade 17-4 SS (ASTMF899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 andB209).
Substantial Equivalence:	The Choice Spine Laminoplasty Fixation System is similar in design,materials and performance to the currently marketed predicates: DePuyMountaineer (K091994), Synthes Arch Fixation System (K032534),Medtronic CENTERPIECE Plate Fixation System (K050082), and SpectrumSpine Laminoplasty Plating System (K122822). The intended use of theproduct as a buttress plate is substantially equivalent in performanceand safety.
Substantial EquivalenceConclusion:	The Choice Spine Laminoplasty Fixation System is similar in design,materials, indications for use, intended use, classification, andperformance to the currently marketed predicates: DePuyMountaineer, the primary (K091994); additional Synthes Arch FixationSystem (K032534); additional Medtronic CENTERPIECE Plate FixationSystem (K050082); and additional Spectrum Spine Laminoplasty PlatingSystem (K122822). The slight differences in the type of Ti Alloy,variation in screw and plate offerings, and selection of allograft vsautograft do not effect performance or safety of these devices.Therefore, the device is substantially equivalent.

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Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.