The Streamline TL Spinal System components are non- cervical spinal 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, pseudoarthosis, and failed previous fusion.

Device Description

The Streamline TL Spinal System consists of a variety of rods, polyaxial screws, transverse connectors, set screws and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, and Connecting components are comprised of Titanium Alloy per ASTM F 136. Rods are comprised of Titanium Alloy per ASTM F 136 or Cobalt Chromium Molybdenum Alloy per ASTM F 1537.

AI/ML Overview

The provided text describes the 510(k) summary for the Pioneer Streamline TL Spinal System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Static and fatigue compression bending per ASTM F1717.	Performed. Results demonstrated that the mechanical performance of the Pioneer Streamline TL Spinal System is substantially equivalent to the predicate devices.
	Static torsion per ASTM F1717.	Performed. Results demonstrated that the mechanical performance of the Pioneer Streamline TL Spinal System is substantially equivalent to the predicate devices.
	Crosslink disassociation (per internal protocols).	Performed. Part of "component performance" testing.
	Saddle/cap separation (per internal protocols).	Performed. Part of "component performance" testing.
	Yoke disassociation from screw head (per internal protocols).	Performed. Part of "component performance" testing.
Technological Characteristics	Polyaxial screw lengths and diameters matching predicate systems.	The Streamline TL Spinal System consists of a range of polyaxial screw lengths and diameters that match that of predicate systems.
	Rods and connecting components identical to predicate systems.	The rods and connecting components are identical to that of the predicate system.
	Intended Use similar to predicate systems.	Intended Use... are similar to that of the predicate systems.
	Materials similar to predicate systems.	Materials are also similar to that of the predicate systems. (Screws, Set Screws, and Connecting components: Titanium Alloy per ASTM F 136. Rods: Titanium Alloy per ASTM F 136 or Cobalt Chromium Molybdenum Alloy per ASTM F 1537).
	Locking mechanism functionality (though differing in design from one predicate).	The mechanism by which this component locks to the screw head is different (threaded vs. cam lock). Performance tested via mechanical testing.

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

Sample Size: The document does not specify the exact sample sizes (e.g., number of implants, cycles, or tests) used for the mechanical testing. It mentions "mechanical testing was presented to characterize construct and component performance."
Data Provenance: The testing was conducted "per recognized ASTM F1717 as outlined in FDA's 'Guidance for Industry and Staff: Spinal Systems 510(k)s' issued May 3, 2004," and "additional testing was performed per internal protocols." This indicates the data is from laboratory testing (likely within the United States, given the FDA submission), not from human or animal subjects. It is prospective in the context of the device's design, as the tests were performed to support the 510(k) submission.

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

This device is a mechanical implant, not an AI/software device that requires human expert interpretation of data or images. Therefore, the concept of "ground truth established by experts" in the context of medical imaging or clinical diagnosis is not applicable here.
The ground truth for mechanical performance is established by the validated testing standards (ASTM F1717) and internal protocols, which are objective engineering criteria. The "experts" would be the engineers and technicians performing and interpreting these mechanical tests according to established scientific and engineering principles. Their specific qualifications (e.g., mechanical engineer, materials scientist) are not detailed but are implicit in conducting such tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert reviews of ambiguous cases, particularly for AI image analysis or diagnostic studies. This is a mechanical device submission where performance is assessed against objective engineering standards.

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 spinal implant, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are relevant.

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 a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective engineering measurements and compliance with established international standards (ASTM F1717) and internal mechanical testing protocols. The "truth" is whether the device can withstand specified static and fatigue loads, and whether its components remain integrated under various stresses, performing equivalently to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set." The design and manufacturing processes are informed by engineering principles, material science, and past experience with similar devices, rather than a data-driven training set.

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

Not applicable, as there is no "training set" in the context of this device's submission.

Summary

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AUG 1 1 2010

3.0	510 (k) Summary
	Sponsor:	Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 225-5602Contact: Emily M. DownsDate prepared: August 10, 2010
	Device Name:	Streamline TL Spinal System
	Classification Name:	$$888.3060$ , Spondylolisthesis Spinal Fixation Device System andPedicle Screw Spinal System - $$888.3070$ , Class III.
	Product Codes:	NKB, KWQ, MNH, MNI, Panel Code 87
	Predicate Device:	K080518 - Quantum Spinal System (SE date - March 20, 2008)K080504 - LowTop Spinal Rod System (SE date - March 20, 2008)
		K003061 - SYNTHES USS (10.0mm Side Opening Screws)K070973 - Quantum Spinal System (SE date - July 3, 2007)
	Description:	The Streamline TL Spinal System consists of a variety of rods,polyaxial screws, transverse connectors, set screws and otherconnecting components used to build a spinal construct.Instrumentation is also available to facilitate implantation of thedevice components.
		The Streamline TL Spinal System is intended to help provideimmobilization and stabilization of spinal segments as an adjunct tofusion of the thoracic, lumbar, and/or sacral/iliac spine. Sacral/iliacscrews are designed for posterior fixation.
		The implant components can be rigidly locked into a variety ofconfigurations, with each construct being tailor-made for theindividual case.
		Screws, Set Screws, and Connecting components are comprised ofTitanium Alloy per ASTM F 136. Rods are comprised of TitaniumAlloy per ASTM F 136 or Cobalt Chromium Molybdenum Alloyper ASTM F 1537.
	Intended Use:	The Streamline TL Spinal System components are non-cervicalspinal fixation devices intended as an adjunct to fusion for use as apedicle screw (T1-S2) sacral/iliac screw fixation or as ananterolateral fixation system (T8 - L5). Pedicle screw fixation islimited to skeletally mature patients. These devices are indicated forall of the following indications: degenerative disc disease (definedas discogenic back pain with degeneration of the disc confirmed byhistory and radiographic studies), spondylolisthesis, trauma, (i.e.,fracture or dislocation), deformities or curvatures (i.e., scoliosis,

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Technological Characteristics	kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.
	The Streamline TL Spinal System consists of a range of polyaxial screw lengths and diameters that match that of predicate systems. The rods and connecting components are identical to that of the predicate system. Intended Use and Materials are also similar to that of the predicate systems.
	Both the Streamline TL and the predicate system use a component (set screw/ cap) that connects to the screw yoke to lock down the rod/ screw head. The mechanism by which this component locks to the screw head is different between the Streamline TL system (threaded) and that of the Pioneer predicate system (cam lock).
Performance Data:	Mechanical testing was presented to characterize construct and component performance, including testing static and fatigue compression bending and static torsion per recognized ASTM F1717 as outlined in FDA's "Guidance for Industry and Staff: Spinal Systems 510(k)s" issued May 3, 2004,
	Additional testing was performed per internal protocols to characterize component performance and included evaluation of crosslink disassociation, saddle/ cap separation, and yoke disassociation from screw head.
	The test results of verification testing demonstrate that the mechanical performance of the Pioneer Streamline TL Spinal System is substantially equivalent to the predicate devices.
Performance and SE Determination:	Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Public Health Service

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

AUG 11 2010

Pioneer Surgical Technology % Ms. Emily M. Downs Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855-0627

Re: K093692

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, KWQ, MNH, MNI Dated: June 08, 2010 Received: June 09, 2010

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

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Page 2 - Ms. Emily M. Downs

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.

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/CDRHQffices/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.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K093692

AUG 1 1 2010

2.0 Indications for Use Statement

510(k) Number (if known):	K093692
Device Name:	Streamline TL Spinal System
Indications for Use:	The Streamline TL Spinal System components are non- cervical spinal 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, pseudoarthosis, and failed previous fusion.

510(k) Number (if known):

K093692

Device Name:

Streamline TL Spinal System

Indications for Use:

Prescription Use
✓
OR
Over-the-Counter Use

(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)

(Division Sign-Off)

(Division Sign-On) Division of Surgical, Orthopedic, and Hestorative Devices

510(k) Number_K093692

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.