When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

Device Description

The Streamline OCT Occipito-Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct.

The purpose of this submission is to add components to the system.

AI/ML Overview

This is a medical device submission (K133374) for the Streamline OCT Occipito-Cervico-Thoracic System, which is a spinal fixation system. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through various comparisons, including pre-clinical testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Benchmarking against predicates)	Reported Device Performance and Comparisons
Mechanical Performance: - Static and Dynamic Compression Bending and Torsion Testing (per ASTM F1717) - Interconnection mechanisms and subassemblies testing (per ASTM F1798)	Pre-Clinical Performance Data: - Subject system evaluated per ASTM F1717. - Subject system evaluated per ASTM F1798. - Conclusion: "Testing demonstrated that the device is as safe, as effective and performs as well as or better than predicate systems."
Technological Characteristics: - Intended use - Basic design (rod-based with screw/hook/plate anchors and connecting components) - Materials (Titanium alloy and cobalt chromium alloy) - Sizes (dimensions comparable to predicates) - Sterilization and cleaning methods - Performance (equivalent mechanical test results)	Technological Characteristics: - "The subject and predicate systems are overall similar in: Intended use, Basic design, Materials, Sizes, Sterilization and cleaning methods, Performance (equivalent mechanical test results)." - "The fundamental scientific technology of the subject system is the same as predicate devices."
Material Equivalence: - Medical grade ASTM F136 titanium alloy - Medical grade ASTM F71537 cobalt chromium alloy	Materials: - "The system components are manufactured from medical grade ASTM F136 titanium alloy and ASTM F71537 cobalt chromium alloy." - "Medical grade titanium alloy and cobalt chromium alloy may be used together."

Sample size used for the test set and the data provenance:
The provided text describes pre-clinical performance data which typically refers to laboratory or bench testing, not human subject testing. Therefore, there is no "test set" in the sense of patient data. The "samples" would be the spinal implant components themselves, tested in a lab setting. The provenance is the testing conducted by Pioneer Surgical Technology, Inc. There is no information regarding the number of components tested in the provided summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This section is not applicable as the "testing" described is mechanical bench testing, not expert review of clinical data to establish ground truth. The "ground truth" here is the specific mechanical properties and failure points determined by the standardized ASTM tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used for clinical studies involving interpretation of data by multiple experts. This submission focuses on engineering and mechanical testing.
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 a spinal implant, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a spinal implant. Performance is evaluated through mechanical testing and comparison to predicate devices, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" is defined by the objective, quantitative criteria established in the ASTM standards (ASTM F1717 and ASTM F1798). These standards define acceptable levels of performance for spinal fixation devices related to static and dynamic compression, bending, torsion, and connector integrity.
The sample size for the training set:
Not applicable. This is a medical device submission for a physical implant, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
Not applicable (no training set for an AI model).

Summary

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Sponsor:	Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USA
Contact:	Bethany BymanPhone: (906) 226-4803Fax: (906) 226-4459
Prepared:	March 19, 2014
Trade name:	Streamline OCT Occipito-Cervico-Thoracic System
Common name:	Posterior Occipito-Cervico-Thoracic System
Classification:	Class II per §888.3050 Spinal Interlaminal fixation orthosis
Product Codes/Panel:	KWPPanel Code 87
Predicates:	Pioneer Streamline Occipito-Cervico-Thoracic (OCT) System (K121725)Exactech Gibralt Occipital Spine System (K110197/K121877)Synthes Cervifix/Axon (K991089/K023675)Nex-Link Spinal Fixation System (K031985)DePuy Mountaineer OCT Spinal System (K110353)NuVasive Vuepoint OCT System (K093319)
Description:	The Streamline OCT Occipito-Cervico-Thoracic System consists of a varietyof rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, lockingcaps, occipital bone screws, occipital plates and connecting components usedto build an occipito-cervico-thoracic spinal construct.The purpose of this submission is to add components to the system.
Materials:	The system components are manufactured from medical grade ASTM F136titanium alloy and ASTM F71537 cobalt chromium alloy. Medical gradetitanium alloy and cobalt chromium alloy may be used together.
Pre-ClinicalPerformance Data:	The subject system was evaluated per ASTM F1717 Static and DynamicCompression Bending and Torsion Testing and compared to legally marketedpredicate systems. Also, ASTM F1798 testing was performed to evaluate theinterconnection mechanisms and subassemblies used in the worst-case spinalconstruct. Testing demonstrated that the device is as safe, as effective andperforms as well as or better than predicate systems.
Intended Use:	When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neckor back pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation,deformities or curvature, tumors, pseudoarthrosis, and revision of previouscervical and upper thoracic spine surgery.The occipital bone screws are limited to occipital fixation only. The use of thepedicle screws (standard and high angle) is limited to placement in the upperthoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screwsare not intended for use in the cervical spine.The hooks, connectors, and rods are also intended to provide stabilization topromote fusion following reduction of fracture/ dislocation or trauma in thecervical/ upper thoracic (C1-T3) spine.The Streamline OCT System can also be linked to FDA cleared pedicle screwsystems (e.g., Quantum Spinal Fixation System, Streamline MIS SpinalFixation System or Streamline TL Spinal System) using connectors.
TechnologicalCharacteristics:	The subject and predicate systems are overall similar in:- Intended use- Basic design: rod-based with screw/hook/plate anchors and connectingcomponents- Materials: Titanium alloy and cobalt chromium alloy- Sizes: dimensions comparable to predicates- Sterilization and cleaning methods- Performance: equivalent mechanical test resultsThe fundamental scientific technology of the subject system is the same aspredicate devices. There are no significant differences between theStreamline OCT System and the predicate devices which would adverselyaffect the use of the product.
SubstantialEquivalence:	This submission supports the position that the subject system issubstantially equivalent to previously cleared pedicle screw systems basedon comparison of indications for use, intended use, materials, technologicalcharacteristics, and pre-clinical performance testing.

510(k) Summary Pursuant to 21 CFR 807.92

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 19, 2014

Pioneer Surgical Technology, Inc. Ms. Bethany Byman Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855

Re: K133374

Trade/Device Name: Streamline OCT Occipito-Cervico-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: February 03, 2013 Received: February 04, 2013

Dear Ms. Byman:

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 device-related 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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Page 2 - Ms. Bethany Byman

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Vincen同)Devlin -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 Statement

510(k) Number (if known): K133374

Device Name: Streamline OCT Occipito-Cervico-Thoracic System

When intended to promote fusion of the cervical spine and occipito-cervico Indications: thoracic junction (occiput-T3); the Streamline Occipito-Cervico-Thoracic (OCT) System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine. The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

V OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Colin O'Neill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133374

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.