The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

Device Description

The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a spinal fixation system. It details the device's indications for use, its description, and a summary of performance testing.

However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The device in question is a physical spinal fixation system, not a software or AI/ML product.

Therefore, I cannot provide the requested information for the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a mechanical medical device and not an AI/ML system.

To answer your request, I would need a document describing the validation activities for an AI/ML-enabled medical device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 14, 2020

Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW Suite 1000 Washington. District of Columbia 20001

Re: K192800

Trade/Device Name: Streamline TL Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: December 13, 2019 Received: December 13, 2019

Dear Justin Eggleton:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K192800

Device Name Streamline TL Spinal Fixation System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Drug 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}------------------------------------------------

1. 510(k) Summary

Name:	Streamline TL Spinal System
Device Trade Name:	Streamline TL Spinal Fixation System
Common Name:	Pedicle screw system
Manufacturer:	Pioneer Surgical Technology, Inc. DBA, RTI Surgical, Inc.375 River Park CircleMarquette, MI 49855 USARegistration no: 1833824
Contact:	Mr. Kurtis HunsbergerRTI Surgical, Inc.5600 Rowland Road, Suite 200Minnetonka, MN 55343 USA
Prepared by:	Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: 202.552.5804jeggleton@mcra.com
Date Prepared:	September 30th, 2019
Classifications:	21 CFR §888.3070, Thoracolumbosacral Pedicle Screw System
Class:	II
Product Codes:	NKB, KWP
Panel:	Orthopaedic and Rehabilitation Devices Panel: Panel Code 87

Indications for Use:

The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

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

Device Description:

Reason for Submission (Modifications to Predicate)

The purpose of this premarket submission is to modify the implants to include hook implants as from a predicate system and add cortical-cancellous bone screws. Additionally, this premarket submission discloses instrument modifications including a pistol rod reducer. Finally, this submission includes an update to the labeling of the Streamline TL Spinal System to acknowledge its Magnetic Resonance safety and compatibility (as demonstrated by appropriate testing).

Primary Predicate Device:

The RTI Streamline TL Spinal System is substantially equivalent to the RTI Streamline TL Spinal System in device indications, design, function, materials, and performance.

Table 1: Primary Predicate Devices
Manufacturer	Device Name	K-Number
RTI	Streamline TL Spinal System	K140696

Additional Predicate Device:

The RTI Streamline TL Spinal System is substantially equivalent to the Quantum Spinal Rod System (RTI Surgical, Inc.; K101790) with respect to the subject device's design.

Materials:

The implant components of the Streamline TL Spinal System are manufactured from implant grade Titanium Alloy per ASTM F136. Spinal rods are also available in Cobalt Chromium Alloy per ASTM F1537.

Performance Testing Summary:

Engineering analyses were performed to demonstrate that performance of the Streamline TL Spinal System was equivalent to the cited predicate devices. Additionally, testing was performed to demonstrate bone screw pull-out strength and to confirm MRI compatibility of the system. The testing is summarized below:

{5}------------------------------------------------

. Cortical-Cancellous Bone Screw Testing (Axial Pull-out Strength, Insertion and Removal Torques per ASTM F543-17 / F2193-18)
. Streamline TL II Executive Test Summary (Axial Static Compression testing, Static Torsion testing, Axial Fatigue testing per ASTM F1717-12 / F1798-97)
Streamline TL Biological Safety Assessment (Genotoxicity and Carcinogenicity per ISO 10993-3, Cytotoxicity per ISO 10993-5, Implantation per ISO 10993-6, Sensitization and Irritation per ISO 10993-10. Acute Systematic Toxicity, Material Mediated Pyrogenicity, Subchronic Systemic Toxicity, and Chronic Systemic Toxicity per ISO 10993-11)
. Streamline TL MRI Conditional Labeling Assessment (Magnetically Induced Displacement Force per ASTM F2052-15, Magnetically Induced Torque per F2213-17, Radio Frequency Induced Heating per F2182-11a, Evaluation of MR Image Artifacts perF2119-07)

Substantial Equivalence:

The Streamline TL Spinal System, with incorporation of the subject components, is substantially equivalent to the predicate in terms of material, design, and indications for use. Engineering analysis was completed for the subject components and demonstrated no pre-clinical performance data was required to demonstrate equivalence of the product. There are no significant differences between the Streamline TL Spinal System and the predicate devices which would adversely affect the use of the product.

The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance.

Conclusion:

The RTI Streamline TL Spinal System is substantially equivalent to the cited predicate devices with respect to its indications for use, design, function, materials, and performance.

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.