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), 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 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 System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to add components to the predicate K133374 Streamline OCT System.

AI/ML Overview

The provided text is a 510(k) summary for the Streamline OCT Occipito-Cervico-Thoracic System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, materials, technological characteristics, and performance.

However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, and study details like sample size, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

The section "Non-Clinical Performance Data" states: "Engineering analysis was sufficient to demonstrate that the subject components do not introduce new worst-case components. Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product and therefore, no new testing was required for the determination of substantial equivalence."

This indicates that no new performance studies were conducted for this specific 510(k) submission (K150254). Instead, it relies on prior testing of the predicate device (K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic System) and engineering analysis.

Therefore, many of your questions cannot be answered from the provided text.

Here's an attempt to answer based on the available information and highlight what's missing:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the Streamline OCT Occipito-Cervico-Thoracic System. It generally states that "Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product."

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

This information is not provided in the document. As no new testing was reported for this submission, there is no mention of a test set sample size or data provenance.

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)

This information is not provided. The device is a spinal fixation system, and the "ground truth" would relate to its mechanical performance and biocompatibility. Expert review might be part of the engineering analysis, but details are not given.

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

This information is not provided.

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 is not applicable. The device is a medical implant (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The device is a physical implant, not an algorithm. Standalone performance for an algorithm is not relevant here.

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

The document implies that the ground truth for the predicate device's performance was established through engineering analysis and testing, which would typically include mechanical testing (e.g., fatigue, static strength), material characterization, and potentially pre-clinical studies or cadaveric testing. It does not refer to expert consensus, pathology, or outcomes data in the context of establishing performance for this 510(k).

8. The sample size for the training set

This information is not provided and is not relevant as this is a physical medical device, not an AI/ML device requiring a training set in that context.

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

This information is not provided and is not relevant for the same reasons as #8.

Summary

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

April 28, 2015

Pioneer Surgical Technology, Incorporated (dba RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855

Re: K150254

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 2, 2015 Received: February 3, 2015

Dear Ms. Pleaugh:

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

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Page 2 - Ms. Sarah Pleaugh

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/Resourcesfor You/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 vours.

Lori A. Wiggins -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)

K150254

Device Name

Streamline OCT Occipito-Cervico-Thoracic System

Indications for Use (Describe)

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

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 As required by 21 CFR 807.92 K15___________________________________________________________________________________________________________________________________________________________________________

Sponsor:	Pioneer Surgical Technology, Inc.(DBA RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USA
Contact:	Sarah Pleaugh
Phone:	(906) 225-5861
Fax:	(906) 226-4459
Prepared:	February 2, 2015
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:	K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic SystemK132332 DePuy Mountaineer OCT Spinal SystemK133556 Zimmer Virage OCT Spinal System
Description:	The Streamline OCT System consists of a variety of rods, hooks, polyaxialscrews, high-angle screws, locking caps, occipital plates, occipital screws,and connecting components used to build an occipito-cervico-thoracicspinal construct. The purpose of this submission is to add components tothe predicate K133374 Streamline OCT System.
Materials:	The Streamline OCT System components are manufactured from ASTMF136 medical grade titanium alloy and ASTM F1537 medical grade cobaltchromium. Medical grade titanium alloy and medical grade cobaltchromium may be used together.
TechnologicalCharacteristics:	The subject components are overall similar in technologicalcharacteristics as compared to the predicates in terms of:- Basic technology: polyaxial screws with threaded locking mechanism,pre-bent OCT spinal rods- Materials: Titanium alloy and cobalt chromium alloy- Design: sizes and dimensions equivalent or comparable to predicatesThere are no significant differences between the subject and predicatedevices which would raise new issues of safety or effectiveness.
	Page 1 of 2
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 (asdefined by neck or back pain of discogenic origin with degeneration of thedisc 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 spinesurgery.The occipital bone screws are limited to occipital fixation only. The use ofthe pedicle screws (standard and high angle) is limited to placement in theupper thoracic spine (T1-T3) in treating thoracic conditions only. Thepedicle screws are not intended for use in the cervical spine.The hooks, connectors, and rods are also intended to provide stabilizationto promote fusion following reduction of fracture/ dislocation or trauma inthe cervical/ upper thoracic (C1-T3) spine.The Streamline OCT System can also be linked to FDA cleared pediclescrew systems (e.g., Quantum Spinal Fixation System, Streamline MISSpinal Fixation System or Streamline TL Spinal System) using connectors.
Non-ClinicalPerformance Data:	Engineering analysis was sufficient to demonstrate that the subjectcomponents do not introduce new worst-case components. Previouslycompleted Streamline OCT System testing is sufficient to support theperformance of the subject product and therefore, no new testing wasrequired for the determination of substantial equivalence. The subjectproduct is expected to be as safe, as effective, and perform as well as thepredicate.
SubstantialEquivalence:	The subject system is substantially equivalent to previously clearedposterior OCT systems based on comparison of intended use, materials,design, technological characteristics, and performance.

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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.