The PressON Pro Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The PressON Pro Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6A1-4V ELI (ASTM F-136).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PressON Pro Spinal Fixation System.

It's important to note that the provided document is a 510(k) summary for a spinal fixation system, which is a medical device. Unlike software algorithms, this document does not contain information about AI algorithm performance metrics, expert consensus for ground truth, or MRMC studies. The "acceptance criteria" discussed here refer to the mechanical performance standards for the physical device.

Description of Acceptance Criteria and Study for the PressON Pro Spinal Fixation System

The PressON Pro Spinal Fixation System is a physical medical device (pedicle screw system), not a software algorithm. Therefore, the "acceptance criteria" and "study" described in the provided 510(k) summary are related to its mechanical performance and substantial equivalence to legally marketed predicate devices, not to diagnostic accuracy or AI model performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Verification Activities)
Axial load per ASTM F1798-13	Mechanical testing performed
A/P load per ASTM F1798-13	Mechanical testing performed
Axial torsion per ASTM F1798-13	Mechanical testing performed
Flexion/extension load per ASTM F1798-13	Mechanical testing performed
Static torsion per ASTM F1717-14	Mechanical testing performed
Static compression bending per ASTM F1717-14	Mechanical testing performed
Dynamic compression bending per ASTM F1717-14	Mechanical testing performed
Substantially equivalent in terms of materials, design, indications for use, and operational principles to predicate devices.	Documentation provided demonstrates substantial equivalence.

Note: The document confirms that testing was performed according to these standards, implying that the device met the requirements of these standards. Specific numerical performance values are not provided in this summary.

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

This information is not applicable and not provided in the 510(k) summary. The "test set" in this context refers to physical device samples undergoing mechanical testing, not a dataset for an algorithm. Mechanical testing would involve a sufficient number of samples to demonstrate statistical confidence in meeting the ASTM standards, but exact numbers are not detailed here. Data provenance (country of origin, retrospective/prospective) is not relevant for mechanical testing of a physical device.

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

This information is not applicable. For a physical device like a spinal fixation system, "ground truth" is established by adherence to recognized engineering and material standards (e.g., ASTM F1798, ASTM F1717) and successful completion of mechanical tests, not by expert review of data or images.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" refers to mechanical samples, not data requiring adjudication. Adjudication methods like "2+1" typically apply to expert reviews for image or data interpretation.

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 information is not applicable. The device is a physical spinal fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established engineering and material standards (ASTM F1798-13, ASTM F1717-14) that define acceptable mechanical properties and performance for spinal implant components. Compliance with these standards, demonstrated through mechanical testing, serves as the "ground truth" for the device's physical integrity and functionality.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" applies to machine learning algorithms, not to the development or testing of a physical medical device. Device development involves engineering design, material selection, and iterative physical testing.

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

This information is not applicable for the reasons stated above.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human face or profile.

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

June 28, 2016

Nexus Spine, LLC Jared Crocker President 2825 East Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121

Re: K160820

Trade/Device Name: PressON Pro Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: June 3, 2016 Received: June 7, 2016

Dear Mr. Crocker:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160820

Device Name

PressON Pro Spinal Fixation System

Indications for Use (Describe)

The PressON Pro Spinal Fixation System is a posterical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral ve disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for Nexus Spine. The word "NEXUS" is written in a sans-serif font, with the "X" formed by two intersecting lines. The letters "NE" are in gray, while the "US" are in a light blue color. Below the word "NEXUS", the word "SPINE" is written in a smaller, sans-serif font, with each letter separated by a space.

510(k) Summary

Submitter:	Nexus Spine LLC
Contact Person:	Mr. Jared Crocker, President2825 East Cottonwood Parkway Suite 330Salt Lake City, UT 84121Telephone: (801) 702-8592Fax: (801) 702-8585
Date Prepared:	March 15, 2016
Trade Name:	PressON Pro Spinal Fixation System
Classification, Nameand Number:	Class IIIPedicle Screw Spinal System21 CFR 888.3070
Product Code:	MNI, MNH and NKB
Predicate Device(s):	The subject device is substantially equivalent to the following devices:
	PressON Pedicle Screw System (Primary Predicate)Marketed and distributed by Nexus Spine, LLC510(K) Number: K133287
	Expedium MOSS Miami Spinal SystemMarketed and distributed by Johnson & Johnson510(K) Number K103490
	Alpine Pedicle Screw SystemMarketed and distributed by Sanacor LLC510(K) Number K090477
Device Description:	The PressON Pro Spinal Fixation System is composed of pedicle screwsand rods. These components can be assembled and implanted usingassociated instruments via a posterior approach into the pedicles of thenoncervical vertebral bodies. Components are made from Ti-6A1-4V ELI(ASTM F-136).
Intended Use:	The PressON Pro Spinal Fixation System is a posterior, non-cervicalpedicle screw system intended to provide immobilization and stabilizationof spinal segments in skeletally mature patients as an adjunct to fusion inthe treatment of the following acute and chronic instabilities or deformitiesof the thoracic, lumbar, and sacral spine: degenerative disc disease (definedas back pain of discogenic origin with degeneration of the disc confirmed
	by history and radiographic studies), spondylolisthesis, fracture, dislocationscoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion(pseudarthrosis).
Statement ofTechnologicalComparison:	The PressON Pro Spinal Fixation System is substantially equivalent tothe above listed predicate devices in terms of materials, design,indications for use and operational principles.
Performance Data:	Verification activities were performed, including mechanical testing asfollows: axial load, A/P load, axial torsion, and flexion/extension load perASTM F1798-13; and static torsion, static compression bending, anddynamic compression bending per ASTM F1717-14.
Conclusion:	Documentation provided demonstrates the PressON Pro Spinal FixationSystem is substantially equivalent to predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for Nexus Spine. The word "NEXUS" is in gray and blue, with the "X" being a stylized design. Below the word "NEXUS" is the word "SPINE" in gray.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.