The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of nonoperative treatment prior to surgery.

The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spimal fusion in patients with:
•degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
•spondylolisthesis,
•trauma (i.e. fractures or dislocations),
•tumors,
•deformity (defined as kyphosis, lordosis, or scoliosis),
•pseudarthrosis,
•failed previous fusion,
•spinal stenosis

Device Description

The ACCUFUSE Cervical System consists of intervertebral body fusion devices along with cervical plates and screws used to maintain disc space distraction in skeletally mature adults requiring an intervertebral body fusion. It is designed to be used in conjunction with supplemental spinal fixation instrumentation. The implant is available in a range of footprints and heights to suit each individual's pathology and anatomical conditions of the patient. The implant has a hollow center to allow placement of autogenous bone graft to promote intervertebral body fusion. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent implant migration and/or expulsion.
The ACCUFUSE Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing single level and two levels of fixation.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the information requested in your prompt (especially regarding acceptance criteria, study design for proving performance, expert involvement, and clinical outcome measures) is not applicable to this type of submission.

Here's a breakdown based on the provided document:

Fundamental Point of the Document: This 510(k) submission for the ACCUFUSE Cervical System aims to demonstrate that its new device is substantially equivalent to legally marketed predicate devices. This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as a legally marketed device. It is not a clinical trial report proving novel performance against predefined acceptance criteria.

Addressing Your Specific Questions (with explanations of why some are not applicable):

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

Not Applicable in the traditional sense of a clinical performance study. This document demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical (mechanical) testing.
Implied "Acceptance Criteria": The acceptance criteria are implicitly that the device performs mechanically in a manner equivalent to the predicate devices when subjected to relevant ASTM standards.
Reported Device Performance:
- Mechanical Testing Results (Summarized): The document states: "The results of these evaluations indicate that the ACCUFUSE Cervical System is equivalent to predicate devices." Specifically, it underwent:
  - Static Axial Compression: Cage per ASTM F2077
  - Dynamic Compression: Cage per ASTM F2077
  - Static Torsion: Cage per ASTM F2077
  - Dynamic Torsion: Cage per ASTM F2077
  - Subsidence: Cage per ASTM F2267
  - Static Axial Compression: Plate per ASTM F1717
  - Dynamic Axial Compression: Plate per ASTM F1717
  - Static Torsion: Plate per ASTM F1717
There is no table explicitly detailing "acceptance criteria" (e.g., minimum load bearing, maximum displacement) and then presenting measured performance values against them within this summary. The claim is simply that the device met the equivalence standard in these tests.

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

Not Applicable (for clinical data): "No clinical studies were performed."
For Non-Clinical (Mechanical) Testing: The document does not specify the sample size (number of devices tested) for the mechanical tests. The provenance is internal to the manufacturer's testing or a contracted lab. It's prospective testing for the purpose of the submission.

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)

Not Applicable: No clinical test set or ground truth (as in clinical diagnosis or outcome) was established by experts. The "ground truth" for the non-clinical testing is the performance of the predicate devices under the same test conditions and established engineering standards (ASTM).

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

Not Applicable: No clinical test set requiring adjudication was performed.

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

Not Applicable: This device is an intervertebral body fusion device and cervical plate/screws, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not Applicable: This is a physical implantable medical device, not an algorithm.

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

For Non-Clinical Testing: The "ground truth" is based on established engineering standards (ASTM F2077, ASTM F2267, ASTM F1717) and the performance characteristics of previously cleared predicate devices in those same tests. There is no clinical "ground truth" in this submission.

8. The sample size for the training set

Not Applicable: This is a physical device, not an AI/ML model that requires a training set.

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

Not Applicable: As above for question 8.

Summary of the Document's Approach:

This 510(k) submission relied primarily on non-clinical (mechanical) testing to demonstrate that the ACCUFUSE Cervical System is substantially equivalent to legally marketed predicate devices. This approach is common for devices where the technology is well-understood and there is a clear predicate that has demonstrated safety and effectiveness. No clinical studies were performed or required for this specific submission.

Summary

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August 29, 2018

Absolute Advantage Medical, LLC % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K181471

Trade/Device Name: ACCUFUSE Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, KWO Dated: May 31, 2018 Received: June 4, 2018

Dear Mr. Webb:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 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.

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) K181471

Device Name ACCUFUSE Cervical System

Indications for Use (Describe)

•degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
•spondylolisthesis,
•trauma (i.e. fractures or dislocations),
•tumors,
•deformity (defined as kyphosis, lordosis, or scoliosis),
•pseudarthrosis,
•failed previous fusion,
•spinal stenosis

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: ACCUFUSE Cervical System

Date Prepared	May 31, 2018
Submitted By	Absolute Advantage Medical, LLC2731 Millbrook RoadFayetteville, NC 28303
Primary Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net
Trade Name	ACCUFUSE Cervical System
Classification Name	Intervertebral Body Fusion Device Spinal Intervertebral body fixation orthosis
Common Name	Intervertebral Fusion Device with Bone Graft, Cervical Appliance, Fixation Spinal Intervertebral Body
Class	II
Product Code	ODP KWQ
CFR Section	21 CFR section 888.3080 21 CFR section 888.3060
Device Panel	Orthopedic
Primary Predicate	Crystal, Spinal Elements, Inc. (K133218)
Additional PredicateDevices	UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 / K100070) BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech (P980048 S3) CLSP Plate, Synthes, (K000536)
Device Description	The ACCUFUSE Cervical System consists of intervertebral body fusion devices alongwith cervical plates and screws used to maintain disc space distraction in skeletallymature adults requiring an intervertebral body fusion. It is designed to be used inconjunction with supplemental spinal fixation instrumentation. The implant is available ina range of footprints and heights to suit each individual's pathology and anatomicalconditions of the patient. The implant has a hollow center to allow placement ofautogenous bone graft to promote intervertebral body fusion. Ridges on the superior andinferior surfaces of the device help to grip the endplates and prevent implant migrationand/or expulsion.The ACCUFUSE Anterior Cervical Plate is intended for anterior screw fixation of the plateto the cervical spine. The fixation construct consists of a cervical plate that is attached tothe vertebral body of the cervical spine with self-tapping or self-drilling bone screws using
	an anterior approach. Plates are available in a variety of lengths addressing single leveland two levels of fixation.
Materials	PEEK per ASTM F2026 Tantalum per ASTM F560 Titanium alloy (Ti-6Al-4V) per ASTM F136
Intended Use	The ACCUFUSE Cervical System is used to maintain disc space distraction inskeletally mature adults requiring intervertebral body fusion of the cervical spine.
SubstantialEquivalence Claimed toPredicate Devices	The ACCUFUSE Cervical System is substantially equivalent to the predicate devicesin terms of intended use, design, materials used, mechanical safety and performances.
Indications for Use	The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for useas an intervertebral body fusion device in skeletally mature patients at one or twocontiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerativedisc disease (DDD) defined as discogenic pain with degeneration of the disc confirmedby patient history and radiographic studies. The ACCUFUSE Cervical System implantsare placed via an anterior approach using autogenous bone graft and/or allograftcomprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE CervicalSystem implants are to be used with supplemental fixation. Patients should have at leastsix weeks of non- operative treatment prior to surgery.The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screwfixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct tofusion of the cervical spine (C2 to T1). The system is indicated for use in the temporarystabilization of the anterior spine during the development of cervical spinal fusion inpatients with:degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis
Summary of thetechnologicalcharacteristicscompared to predicate	Intended UseThe ACCUFUSE Cervical System and all the predicates have similar intended uses.MaterialsThe ACCUFUSE Cervical System is composed of the same material as the predicatedeviceDesign Features/FunctionsThe ACCUFUSE Cervical System and cited predicate devices share similar basic designfeatures and functions.DimensionsThe ACCUFUSE Cervical System is dimensionally similar to cited predicate devices.SterilizationThe ACCUFUSE Cervical System is provided non-sterile and cited predicate devices arenon-sterile for single use only.Performance SpecificationMechanical testing confirmed the ACCUFUSE Cervical System demonstrated equivalentperformance to the cited predicate device under the same test conditions.
Non-clinical TestSummary	The following analyses were conducted:• Static Axial Compression: Cage per ASTM F2077• Dynamic Compression: Cage per ASTM F2077• Static Torsion: Cage per ASTM F2077• Dynamic Torsion: Cage per ASTM F2077• Subsidence: Cage per ASTM F2267• Static Axial Compression: Plate per ASTM F1717• Dynamic Axial Compression: Plate per ASTM F1717• Static Torsion: Plate per ASTM F1717The results of these evaluations indicate that the ACCUFUSE Cervical System isequivalent to predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Absolute Advantage Medical considers the ACCUFUSE Cervical System to beequivalent to the predicate devices listed above. This conclusion is based upon thedevices' similarities in principles of operation, technology, materials, performance, andintended use

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.