The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Device Description

The Streamline MIS Spinal Fixation System is a multiple component pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct through an open or percutaneous approach. The implant components include rods, polyaxial pedicle screws with extended tabs, crosslinks, and locking set screws. The components are available in various sizes to accommodate differing patient anatomy. The system is attached to the pedicles by means of screws to the posterior, noncervical spine. The spinal construct is completed by connecting the screws with titanium alloy rods. Crosslinks can be used if additional stabilization is necessary.

All implant components of the Streamline MIS Spinal Fixation System are manufactured from the implant grade Ti 6Al/4V ELI Alloy, Grade 23 (ASTM F136).

The Streamline MIS Spinal Fixation System components are used with the Streamline TL System locking set screws and crosslinks, and the Quantum Spinal System Crosslinks.

The Streamline MIS Spinal Fixation System includes instrumentation to provide the surgeon with a minimally invasive approach for posterior spinal surgery. Class I manual instruments are also included.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details as requested:

Device: Streamline MIS Spinal Fixation System (Pedicle Screw System)

This document describes a 510(k) premarket notification for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria for performance metrics (like sensitivity/specificity for AI). Therefore, the "acceptance criteria" here refer to the standards for demonstrating substantial equivalence, and the "study" refers to the pre-clinical performance testing against those standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Intended Use	Subject and predicate systems are overall similar in intended use (posterior, noncervical pedicle fixation, T1-S2, as an adjunct to fusion for various indications).
Basic Design: Rod-based having screw anchors	Subject and predicate systems are overall similar in basic design.
Materials: Titanium Alloy per ASTM F136	All implant components manufactured from implant grade Ti 6Al/4V ELI Alloy, Grade 23 (ASTM F136). Subject and predicate systems are overall similar in materials.
Sizes: dimensions comparable to predicates	Subject and predicate systems are overall similar in sizes.
Performance: ASTM F1717 equivalent results	Evaluated per ASTM F1717 Static Compression Bending and Torsion, and Dynamic Compression Bending Testing. Demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of human subject testing. The "test set" here refers to the physical device components tested in pre-clinical mechanical performance studies. The document does not specify the number of individual components or constructs tested for ASTM F1717.
Data Provenance: The studies were pre-clinical performance tests conducted to physical samples of the device. The data is thus generated in a lab setting, not from patient data, and is therefore neither retrospective nor prospective. The location of the testing is not explicitly stated but is implied to be performed by or for the manufacturer (Pioneer Surgical Technology, Inc., Marquette, MI, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context refers to the outcome of physical/mechanical tests based on established engineering standards (ASTM F1717), not expert interpretation of medical images or patient outcomes. The evaluation is based on objective measurements from mechanical testing machines.

4. Adjudication Method for the Test Set

Not applicable. This was a pre-clinical mechanical performance study against a standard, not a study requiring adjudication of expert opinions.

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 is a 510(k) submission for a non-AI, mechanical spinal fixation system. No human reader studies, AI assistance, or MRMC studies were conducted or are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by standardized mechanical testing protocols (ASTM F1717). This involves objective physical measurements of the device's strength, stiffness, and durability under compression, bending, and torsion, which are then compared to the performance of predicate devices or established minimum standards.

8. The Sample Size for the Training Set

No "training set" in the context of an AI algorithm is applicable. This is a mechanical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

Summary

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APR 0 1 2013

510(k) Summary Pursuant to 21 CFR 807.92

K130286 Page 1 of 2

	K1302Page510(k) Summary Pursuant to 21 CFR 807.92
Sponsor:	Pioneer Surgical Technology, Inc.375 River Park CircleMarquette, MI 49855 USAPh: (906) 225-5602Fx: (906) 226-4459Contact: Emily DownsPrepared: March 13, 2013
Trade name:	Streamline MIS Spinal Fixation System
Common name:	Pedicle Screw System
Classification:	888.3070 Pedicle Screw Spinal System; Class III
Product Codes/Panel:	NKB, MNH, MNIPanel Code 87
Predicates:	K111502 Streamline TL Spinal System (SE 8-23-2011)K101790 Quantum Spinal System (SE 3-7-2011)K093771 Streamline MIS Cannulated Screw System (SE 8-10-2010)K022949 Synthes USS (SE 3-24-2003)
Description:	The Streamline MIS Spinal Fixation System is a multiple componentpedicle screw system comprised of a variety of components that allow thesurgeon to build a spinal implant construct through an open orpercutaneous approach. The implant components include rods, polyaxialpedicle screws with extended tabs, crosslinks, and locking set screws. Thecomponents are available in various sizes to accommodate differingpatient anatomy. The system is attached to the pedicles by means ofscrews to the posterior, noncervical spine. The spinal construct iscompleted by connecting the screws with titanium alloy rods. Crosslinkscan be used if additional stabilization is necessary.All implant components of the Streamline MIS Spinal Fixation Systemare manufactured from the implant grade Ti 6Al/4V ELI Alloy, Grade 23(ASTM F136).The Streamline MIS Spinal Fixation System components are used withthe Streamline TL System locking set screws and crosslinks, and theQuantum Spinal System Crosslinks.The Streamline MIS Spinal Fixation System includes instrumentationto provide the surgeon with a minimally invasive approach for

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posterior spinal surgery. Class I manual instruments are also included. The Streamline MIS Spinal Fixation System is intended for posterior, Intended Use: noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. This submission supports the position that the subject system is Substantial Equivalence substantially equivalent to previously cleared pedicle screw systems based on comparison of indications for use, intended use, materials, technological characteristics, and pre-clinical performance testing. Technological The subject and predicate systems are overall similar in: Characteristics: - Intended use (described above) - Basic design: rod-based having screw anchors - Materials: Titanium Alloy.per ASTM F136 - Sizes: dimensions comparable to predicates - Performance: ASTM F1717 equivalent results The fundamental scientific technology of the subject system is the same as predicate devices. There are no significant differences between the Streamline MIS Spinal Fixation System and the predicate devices which would adversely affect the use of the product. The subject system was evaluated per ASTM F1717 Static Compression Pre-Clinical Bending and Torsion, and Dynamic Compression Bending Testing and Performance Data: compared to predicate devices. This testing demonstrated that the device is as safe, as effective and performs as well as or better than the predicate device. The subject system is substantially equivalent to valid predicate Conclusion: devices and in this submission was found to be at least as safe and effective as the predicate device based on similarities in materials, technology, labeling and performance.

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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

Pioneer Surgical Technology, Incorporated % Ms. Emily Downs 375 River Park Circle Marquette, Michigan 49855

Letter dated: April 1, 2013

Re: K130286

Trade/Device Name: Streamline MIS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Codes: NKB, MNI, MNH Dated: February 1, 2013 Received: February 5, 2013

Dear Ms. Downs:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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4.0 Indications for Use Statement

K130286 Page 1 of 1

510(k) Number (if known): K130286

Device Name:

Streamline MIS Spinal Fixation System

Indications:

The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

V Prescription Use OR (Per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130286

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.