The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

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. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system. Cases and caddies are supplied for sterilization and transport of the implants and instruments. The purpose of this submission is to modify and add components to the system.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." This kind of document focuses on demonstrating that a new device is "substantially equivalent" to existing legally marketed devices, rather than establishing acceptance criteria and proving performance against them in the same way one might for a novel device or software.

Therefore, the requested information, particularly regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies, is not typically found or required in a 510(k) submission for this type of device (spinal fixation system). The demonstration of substantial equivalence relies more on comparing the new device's design, materials, indications for use, and mechanical performance to existing predicate devices.

However, I can extract the information that is available in the document that somewhat aligns with your request:

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

There isn't a table of "acceptance criteria" and reported device performance in the sense of accuracy, sensitivity, or specificity for an AI/software device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence through non-clinical mechanical testing. The "reported device performance" refers to the results of these mechanical tests compared to predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
Components do not introduce new worst-case scenarios.	Engineering analysis, including ASTM F1798 testing, confirmed that subject components do not introduce new worst-case components or cause the system to be more susceptible to loosening or failure.
Mechanical performance is substantially equivalent to predicates.	Mechanical construct testing (ASTM F1717 and ASTM F2706) demonstrated that the subject and predicate systems are substantially equivalent. No new risks to safety or effectiveness were raised by the non-clinical testing.
No new risks to safety or efficacy.	The submission demonstrates there are no new risks to safety or efficacy raised by the subject Streamline OCT System.

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

Sample Size for Test Set: Not applicable in the context of this 510(k) for a spinal fixation system. There isn't a "test set" of clinical data or images as typically understood for AI/software. The testing involved mechanical tests of the devices themselves.
Data Provenance: Not applicable. The "data" comes from mechanical testing conducted in a laboratory setting, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as established by clinical experts for a test set is not relevant for this type of device's 510(k) submission. Mechanical testing relies on engineering standards and measurements.

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

Not applicable. This concept is for clinical data review, not mechanical testing.

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

Not applicable. This device is a physical spinal fixation system, not an AI or software device that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" is established by validated engineering test standards (ASTM F1798, ASTM F1717, and ASTM F2706) and the results derived from those specified testing protocols.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical medical device. Device design and refinement are based on engineering principles, materials science, and testing, not machine learning training.

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

Not applicable (as there's no training set). The design and development of the device components are informed by established engineering practices and biomechanical understanding of spinal anatomy and mechanics.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

August 18, 2017

Re: K172139

Trade/Device Name: Streamline OCT Occipito-Cervico-Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: July 13, 2017 Received: July 17, 2017

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 (DICE) 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 (DICE) 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) K172139

Device Name

Streamline OCT Occipito-Cervico-Thoracic System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The "i" in "rti" has a small green leaf-like shape above it.

510(k) Summary As required by 21 CFR 807.92

As required by 21 CFR 807.92
Company:	Pioneer Surgical Technology, Inc.DBA RTI Surgical, Inc.375 River Park CircleMarquette, MI 49855 USAPhone: (906) 226-9909Fax: (906) 225-5868Prepared: July 13, 2016
Contact:	Sarah Pleaugh, Regulatory Affairs Specialist
Trade name:	Streamline OCT Occipito-Cervico-Thoracic System
Common name:	Posterior Occipito-Cervico-Thoracic System
Classification:	Unclassified; Pre-amendment device (Product Code NKG -Orthosis, Cervical Pedicle Screw Spinal Fixation)Class II; 21 CFR 888.3050 (Product Code KWP - Appliance,Fixation, Spinal Interlaminal)
Panel:	Panel Code 87
Predicates:	Primary Predicate: Pioneer Surgical Technology, Inc. DBA RTISurgical, Inc. Streamline OCT System (K161498)Additional Predicates:Medtronic VERTEX Reconstruction System (K143471)DePuy Summit/Mountaineer OCT System (K151885)Exactech Gibralt® Spine System and Gibralt® Occipital SpineSystem (K160697)
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 anoccipito-cervico-thoracic spinal construct. System components aremanufactured from ASTM F136 medical grade titanium alloy andASTM F1537 medical grade cobalt chromium molybdenum alloy.Medical grade titanium alloy and medical grade cobalt chromiummolybdenum alloy may be used together. The system should beimplanted using only the surgical instruments designed for thesystem. Cases and caddies are supplied for sterilization andtransport of the implants and instruments.The purpose of this submission is to modify and add components tothe system.
Indications forUse:	The Streamline OCT Occipito-Cervico-Thoracic System is intendedto provide immobilization and stabilization of spinal segments as anadjunct to fusion when using autograft and/or allograft for thefollowing acute and chronic instabilities of the craniocervical
junction, the cervical spine (C1 to C7) and the thoracic spine (T1 toT3): traumatic spinal fractures and/or traumatic dislocations;instability or deformity; failed previous fusions (e.g., pseudarthrosis);tumors involving the cervical/thoracic spine; and degenerativedisease, including intractable radiculopathy and/or myelopathy, neckand/or arm pain of discogenic origin as confirmed by radiographicstudies, and degenerative disease of the facets with instability.The system is also intended to restore the integrity of the spinalcolumn even in the absence of fusion for a limited time period inpatients with advanced stage tumors involving the cervical spine inwhom life expectancy is of insufficient duration to permitachievement of fusion.In order to achieve additional levels of fixation, the Streamline OCTSystem may be connected to the Quantum Spinal Fixation System,Streamline MIS Spinal Fixation System or Streamline TL SpinalSystem using connectors and/or transition rods.
Summary ofTechnologicalCharacteristics:	The subject system has a similar fundamental scientifictechnology as the predicates. The subject system utilizesequivalent surgical approaches, fundamental technology, designs,materials, sterilization and packaging as the predicate devices.
Discussion ofSupportingClinical Evidenceand Non-ClinicalTesting:	Engineering analysis, including ASTM F1798 testing, was presentedto confirm that the subject components do not introduce new worst-case components or cause the system to be more susceptible toloosening or failure. Mechanical construct testing (ASTM F1717and ASTM F2706) demonstrated that the subject and predicatesystems are substantially equivalent. No new risks to safety oreffectiveness were raised by the non-clinical testing.
SubstantialEquivalence andComparison toLegally MarketedDevices:	The design features, materials, indications for use, surgicalapproach, mechanical performance and fundamental technologyare substantially equivalent to predicate devices. This submissiondemonstrates there are no new risks to safety or efficacy raisedby the subject Streamline OCT System.

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Image /page/4/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The "i" in "rti" has a small green dot above it.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.