The Streamline 71. Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (TI-S2). sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc discase (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), turnor, stenosis, pseudoarthrosis, and failed previous fusion.

Device Description

The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), transverse connectors, set screws 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. Sacral/iliac screws are designed for posterior fixation. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components. The Streamline TL Spinal System may be used with the Streamline TL Crosslink, SpineWorks FixxSure Crosslink or the Quantum® Spinal System X-Link® and rods. This 510(k) is intended to introduce a line extension to the existing Streamline TL Spinal System. The line extension consists of additional diameters for the poly-axial screws.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:

Based on the provided text, the Streamline TL Spinal System is a Class III medical device requiring premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel technology.

Crucially, the provided text does not describe any specific acceptance criteria or a study designed to prove the device meets such criteria in the way one might expect for a diagnostic AI/ML device.

Instead, the submission focuses on substantial equivalence to existing predicate devices.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)

Since this document is for a spinal fixation system, there are no "acceptance criteria" for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC). The "performance" of this device is assessed through its material properties, design, and intended use being substantially equivalent to a predicate.

Acceptance Criteria	Reported Device Performance
Not applicable, as this is not an AI/ML device.	Not applicable, as this is not an AI/ML device.
(e.g., Sensitivity > X%)	(e.g., Achieved Y% Sensitivity)
(e.g., Specificity > Z%)	(e.g., Achieved W% Specificity)

Study Information (Focused on Substantial Equivalence, not AI/ML performance)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a clinical study in the AI/ML context. The submission states: "Engineering analysis was completed for the subject components and demonstrated no pre-clinical performance data was required to demonstrate equivalence of the product." This indicates that physical testing (e.g., mechanical, fatigue) of the new components to demonstrate equivalence was likely performed, rather than a clinical trial with a "test set" of patients or data. No details on the sample size for this engineering analysis are provided, nor is data provenance relevant in this context.
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):
- Not applicable. There was no clinical "test set" requiring expert-established ground truth for performance evaluation in the context of an AI/ML device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical "test set" requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a pedicle screw system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the clinical sense (for AI/ML performance) was needed. The "ground truth" for this device's safety and effectiveness relies on its physical properties and design conforming to established standards and demonstrating equivalence to predicate devices, which have already been deemed safe and effective.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
How the ground truth for the training set was established:
- Not applicable. This device does not involve a "training set."

Summary of the Product's Regulatory Pathway Based on the Provided Text:

The Streamline TL Spinal System (specifically the line extension with additional poly-axial screw diameters) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices (the original Pioneer Streamline TL Spinal System and Blackstone Medical's Firebird Spinal Fixation System).

The primary method for demonstrating this equivalence was through engineering analysis, which concluded that "no pre-clinical performance data was required to demonstrate equivalence of the product." This means that the FDA was satisfied that the new components did not raise new questions of safety or effectiveness, and their performance could be inferred from the predicate devices through design and material similarities, likely backed by mechanical testing (though not explicitly detailed as "data" in this summary).

Summary

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510(k) Summary Pursuant to 21 CFR 807.92

Pioneer Surgical Technology, Inc. Sponsor: (RTI Surgical, Inc.) 375 River Park Circle Marquette, MI. 49855 USA Contact: Sarah McIntyre Ph: (906) 225-5861 Fx: (906) 226-4459 Prepared: March 18, 2014 Name: Streamline TL Spinal System Trade name: Streamline TL Spinal Fixation System Common name: Pedicle screw system 21 CFR 888.3060, Spondylolisthesis Spinal Fixation Device System and 21 Classifications: CFR 888.3070 Pedicle Screw Spinal System, Class III Product Codes: NKB, KWQ, MNI, MNH Panel/ Branch: Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 Predicates: Pioneer Streamline TL Spinal System (K131100) Blackstone Medical, Inc. Firebird Spinal Fixation System (K093926) The Streamline TL Spinal System consists of a variety of rods, screws Description: (poly-axial, fixed, and reduction), transverse connectors, set screws 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. Sacral/iliac screws are designed for posterior fixation. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components. The Streamline TL Spinal System may be used with the Streamline TL Crosslink, SpineWorks FixxSure Crosslink or the Quantum® Spinal System X-Link® and rods. Description of This 510(k) is intended to introduce a line extension to the existing Streamline TL Spinal System. The line extension consists of additional Device Modification: diameters for the poly-axial screws.

APR 1 0 2014

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The Streamline TL Spinal System components are non-cervical spinal Intended Use: fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). 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, pseudoarthrosis, and failed previous fusion.

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

Substantial The Streamline TL Spinal System, with incorporation of the subject Equivalence 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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 10, 2014

Pioneer Surgical Technology, Incorporated Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855

Re: K140696

Trade/Device Name: Streamline TL Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWO Dated: March 18, 2014 Received: March 19, 2014

Dear Ms. McIntyre:

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. Sarah Meintyre

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" (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 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,

RonaldiPhylean -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)

K140696

Device Name

Streamline TL Spinal System

Indications for Use (Describe)

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)

2014.04.10

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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.