The Ibis® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ilium) for the following indications:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Degenerative Spondylolisthesis with objective evidence of neurologic impairment
Trauma (fracture or dislocation)
Spinal tumor
Failed previous fusion (pseudarthrosis)
Spinal stenosis
Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

Device Description

The Ibis® Pedicle Screw System consists of bulleted rods; cannulated polyaxial, monoaxial, extended length (Ibis® XL) and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis® Pedicle Screw System maintains compatibility with the Pagoda Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, the study that proves the device meets those criteria, or any details about an AI algorithm or its performance.

The document is an FDA 510(k) premarket notification for the "Ibis® Pedicle Screw System," specifically focusing on a line extension (Ibis® XL Cannulated Polyaxial Screws). It discusses:

Device Name and Classification: Ibis® Pedicle Screw System, Class II, Regulation Number 21 CFR 888.3070 (Thoracolumbosacral pedicle screw system).
Indications for Use: Provides immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, tumor, failed fusion, spinal stenosis, spinal deformities).
Substantial Equivalence: The primary purpose of the document is to demonstrate substantial equivalence to previously cleared predicate devices (Ibis® Pedicle Screw System K142146, Pagoda® Pedicle Screw System K131785, and additions to EXPEDIUM® and VIPER® Systems K101993).
Device Description: Components, materials (Titanium Alloy), and compatibility with other systems.
Nonclinical Test Summary: Mentions mechanical tests performed (Static Compression Bending, Dynamic Compression Bending, Axial Torque Gripping Capacity) in accordance with ASTM standards, to support the device's mechanical integrity and performance, aligning with equivalence to predicate devices. These are engineering performance tests, not clinical performance or AI performance.

Therefore, I cannot answer your specific questions regarding acceptance criteria, AI study details, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected, forming a single, continuous shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

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

March 30, 2017

Ortho Development Corporation Ms. Lindsay Martin Manager, Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020

Re: K162995

Trade/Device Name: Ibis® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 10, 2017 Received: January 11, 2017

Dear Ms. Martin:

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K162995

Device Name Ibis® Pedicle Screw System

Indications for Use (Describe)

The Ibis® Pedicle Screw System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 - Sacrum/Ileum) for the following indications:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
1. Trauma (fracture or dislocation)
1. Spinal tumor
1. Failed previous fusion (pseudarthrosis)
1. Spinal stenosis
1. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

Type of Use (Select one or both, as applicable)

2 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Name of Sponsor:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Lindsay MartinManager, Regulatory AffairsTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: LMartin@orthodevelopment.com
Date Prepared:	March 27, 2017
Proprietary Name:	Ibis® Pedicle Screw System
Common Name:	Thoracolumbosacral Pedicle Screw System
Classification:	21 CFR 888.3070
Device Product Code:	NKB
Class:	Class II
Primary Predicate Device:	Ibis® Pedicle Screw System (K142146)Ortho Development Corporation
Additional Predicate Devices:	Pagoda® Pedicle Screw System (K131785)Ortho Development CorporationAdditions to the EXPEDIUM® and VIPER® Systems (K101993)Depuy Spine, Inc

Description

{4}------------------------------------------------

Indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
1. Trauma (fracture or dislocation)
1. Spinal tumor
1. Failed previous fusion (pseudarthrosis)
1. Spinal stenosis
1. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

Basis for Substantial Equivalence:

The Ibis® XL Cannulated Polyaxial Screws are a line extension of the Ibis® Pedicle Screw System and have the following similarities to those which previously received 510(k) concurrence (K142146):

have the same indicated use,
. incorporate the same basic polyaxial ball-socket and screw thread design,
. incorporate the same materials,
have the same interconnection components (set screw and 5.5mm bulleted rod),
have the same shelf life, and
. are packaged and sterilized using the same materials and processes.

In summary, the Ibis® XL Cannulated Polyaxial Screws described in this submission are, in our opinion, substantially equivalent to the predicate device.

Nonclinical Test Summary:

The following mechanical tests were conducted:

Static Compression Bending in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
. Dynamic Compression Bending in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
. Axial Torque Gripping Capacity in accordance with ASTM F1798 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants"

Conclusions:

Ibis® XL Cannulated Polyaxial Screw has substantially the same intended use, indications for use, materials, general dimensions, performance, and principles of operation as the predicate devices.

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.