The Huvex Interspinous Fixation System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Huvex Interspinous Fixation System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

Device Description

The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different Huvex Interspinous Fixation implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided.

AI/ML Overview

The provided document is a 510(k) summary for the Huvex Interspinous Fixation System. It describes the device, its intended use, and that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, the document does not describe acceptance criteria, the specific study design to prove acceptance criteria were met, or detailed performance results in the format requested.

It states general categories of tests performed but lacks the quantitative details needed to answer all parts of your request.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states:

"Static & Dynamic compression, Static torsion, and Static tension testing in accordance with a modified ASTM F1717 setup"
"Static grip testing with a modified ASTM F1798 setup"
"were conducted to demonstrate substantial equivalence to the predicate system(s)."

It does not provide specific acceptance criteria values (e.g., maximum deflection, fatigue cycles survived, ultimate load) or the quantitative performance results (e.g., "Device A survived X cycles," or "Device A withstood Y N of compression"). It only indicates that these tests were performed and deemed sufficient for substantial equivalence.

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

Not available in the provided document. The document does not specify the number of samples (implants) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not relevant for mechanical bench testing of an implant; these tests are typically conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This question pertains to clinical studies involving human interpretation or pathology. The provided document describes mechanical bench testing of a medical implant, not a diagnostic device or a clinical study that requires expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This question relates to clinical studies and expert review for ground truth, not mechanical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The Huvex Interspinous Fixation System is a surgical implant, and no MRMC study would be performed for its clearance.

6. Standalone Performance Study

The document describes standalone mechanical performance testing as part of its substantial equivalence claims. The tests mentioned (Static & Dynamic compression, Static torsion, Static tension, Static grip) are performed on the device itself (or device constructs) without a human in the loop. The "performance and SE determination" section says, "The Huvex Interspinous Fixation System has been demonstrated to be substantially equivalent to the predicate system(s) with respect to technical characteristics, performance, and intended use." This implies that the device's mechanical performance, in isolation, was evaluated against established standards or predicate device performance.

However, specific quantitative results from these standalone tests are not provided in this summary.

7. Type of Ground Truth Used

Not applicable in the sense of clinical ground truth. For mechanical testing, the "ground truth" or reference is typically defined by:

ASTM standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Constructs) are mentioned, albeit as "modified" setups. These standards define the methodology for testing.
Predicate device performance: The goal is to demonstrate "substantial equivalence" to predicate devices, meaning the device performs comparably mechanically. The performance of the predicate device acts as the benchmark.

8. Sample Size for the Training Set

Not applicable. Surgical implants undergo mechanical testing, not algorithm training using a "training set" of data in the AI sense.

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

Not applicable. As above, there is no "training set" for this type of device and evaluation.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through mechanical bench testing. It lists the types of tests conducted and the standards referenced but does not provide the quantitative acceptance criteria or specific performance results that would directly answer your request in detail.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 16, 2017

DIO Medical Co., Ltd. Mr. Jaewon Jang Manager 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, Illinois 60631

Re: K162849

Trade/Device Name: Huvex Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: January 27, 2017 Received: January 30, 2017

Dear Mr. Jang:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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) K162849

Device Name Huvex Interspinous Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Registration for Part 40 CFR 266, Subpart S Burner
On-Site Combustion Unit (No CFR)
|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

DIO Medical Co., Ltd.

Huvex Interspinous Fixation System

Sponsor: DIO Medical Co., Ltd. 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, Illinois 60631 Official Contact: Jaewon Jang Phone: 847-795-1078 ext. 103 Date Prepared: February 15, 2017 Device Name: Huvex Interspinous Fixation System Common Name: Spinous Process Plate Classification Spinal interlaminal fixation orthosis Name: Classification 21 CFR 888.3050 Number: Product PEK, class II Code/Classification: Description: The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different Huvex Interspinous Fixation implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided.

Both implant and instruments have trays that are used for handling and storage.

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Intended Use:	The Huvex Interspinous Fixation System is a single-level, posterior, non-pediclesupplemental fixation device intended for use in the non-cervical spine (T1-S1) as aradjunct to fusion in skeletally mature patients. It is intended for platefixation/attachment to the spinous processes for the purpose ofachieving supplemental fusion in the following conditions: degenerative discdisease (defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), and/or tumor. The Huvex Interspinous Fixation System isintended for use at one level, in conjunction with autogenous bone graft, and notintended for stand-alone use.
Performance Data:	Static & Dynamic compression, Static torsion, and Static tension testing inaccordance with a modified ASTM F1717 setup, in addition Static grip testingwith a modified ASTM F1798 setup were conducted to demonstrate substantialequivalence to the predicate system(s).
Predicate Device:	Primary predicate: Globus Medical- Sp-Fix Spinous Process Fixation Plate(K102195)Additional predicates: Medtronic - CD Horizon SPIRE™ Spinous Process Plate(K032037), NuVasive - Affix I & II Spinous Process Plate system (K131238 &K143388), Alphatec Spine - Bridgepoint Spinous Process System (K103205) and LifeSpine - Aileron posterior fusion system (K140236)
Performance andSE Determination:	The Huvex Interspinous Fixation System has been demonstrated to besubstantially equivalent to the predicate system(s) with respect to technicalcharacteristics, performance, and intended use. The information provided withinthis premarket notification supports substantial equivalence of the subject deviceto the predicate device(s).

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.