The SpineTune™ TL Spinal System is a posterior, non-cervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

Spondylolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective evidence of neurological . impairment
Trauma (i.e., fracture or dislocation)
Spinal stenosis .
Deformities or curvatures (i.e., scoliosis, . kyphosis, and/or lordosis)
Tumor .
Pseudoarthrosis .
Failed previous fusion .

Device Description

The SpineTune TL Spinal System is a top-loading posterior spinal pedicle fixation system consisting of various pedicle screws, rods, set screws, and transverse, lateral, axial, and domino type connectors. The 8.0mm and 8.5mm polyaxial screws are a design modification of the 8.0mm and 8.5m polyaxial screws cleared in the predicate SpineTune TL Spinal System (K100575, K102331). Cannulated 8.0mm and 8.5mm polyaxial screws, additional lengths of 7.5mm polvaxial, monoaxial, and reduction screws and curved rods, and several device specific instruments, are additions to the previously cleared SpineTune TL Spinal System.

AI/ML Overview

The provided text describes a 510(k) summary for the LDR Spine USA SpineTune TL Spinal System, focusing on mechanical non-clinical testing for substantial equivalence to a predicate device. It does not contain information about the performance of an AI/ML powered device, or any clinical study involving human readers or AI assistance. Therefore, it is impossible to answer the questions related to AI/ML device performance, human readers, or ground truth establishment based on the provided input.

However, I can extract information related to the acceptance criteria for the mechanical tests:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria	Reported Device Performance
Dynamic Compression Bending Test (ASTM F-1717)	The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).	The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
Flexion-Extension Cantilever Test (ASTM F-1798)	The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).	The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
Axial Gripping Capacity Test (ASTM F-1798)	The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).	The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
Overtightening Test (ASTM F-1798)	The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).	The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
Static Torsion Test (ASTM F-1717)	The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).	The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.

Summary of the study:
The study involved non-clinical mechanical testing of the modified 8.0mm and 8.5mm diameter polyaxial screws of the SpineTune TL Spinal System. The purpose was to demonstrate substantial equivalence to the predicate SpineTune TL Spinal System (K100575, K102331). The specific tests performed were Dynamic Compression Bending, Flexion-Extension Cantilever, Axial Gripping Capacity, Overtightening, and Static Torsion, all conforming to relevant ASTM standards. The conclusion was that the device met the acceptance criteria and performed as well or better than the predicate device.

Information not available in the provided text:

2. Sample sized used for the test set and the data provenance: The document does not specify the number of samples used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable or provided as it is non-clinical mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML powered device, and no "ground truth" in the context of expert review is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the performance standards and criteria set by the predicate device and relevant ASTM standards.
8. The sample size for the training set: Not applicable as this is not an AI/ML powered device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML powered device.

Summary

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JUN 2 7 2012

510(k) Summarv LDR Spine USA SpineTune TL Spinal System

Owner's Name & Address:

LDR Spine USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 Phone: (512) 344-3333 (512) 344-3350 Fax: ·

Contact Person:

Kiersten Soderman Regulatory Affairs Specialist

LDR Spine USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 Phone: (512) 344-3370 Fax: (512) 344-3350 Email: kierstensoderman@ldrspine.com

Date:

Common Name:

Classification Name:

Product Codes:

Proprietary Name:

Legally Marketed Predicate Device:

Device Description

March 9, 2012

Pedicle Screw Spinal System

Pedicle Screw Spinal System (per CFR 888.3070)

MNH (per CFR 888.3070)- Orthosis, Spondilolisthesis Spinal Fixation MNI (per CFR 888.3070)- Orthosis, Spinal Pedicle Fixation KWP (per CFR 888.3050)- Orthosis, Spinal Interlaminal Fixation

LDR Spine SpineTune TL Spinal System

LDR Spine SpineTune TL Spinal System (K100575, K102331)

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510(k) Summarv

LDR Spine USA SpineTune TL Spinal System

cleared in the predicate SpineTune TL Spinal System (K100575, K102331). Cannulated 8.0mm and 8.5mm polyaxial screws, additional lengths of 7.5mm polvaxial, monoaxial, and reduction screws and curved rods, and several device specific instruments, are additions to the previously cleared SpineTune TL Spinal System.

The SpineTune™ TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

Spondylolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective . evidence of neurological impairment
. Trauma (i.e., fracture or dislocation)
Spinal stenosis .
Deformities or curvatures (i.e., scoliosis, . kyphosis, and/or lordosis)
Tumor .
Pseudoarthrosis .
Failed previous fusion .

Non-clinical testing on the proposed 8.0mm and 8.5mm diameter polyaxial screws included an engineering analysis and the following mechanical tests:

Dynamic Compression Bending Test (ASTM F-. 1717)

Flexion-Extension Cantilever Test (ASTM F-. 1798)

Axial Gripping Capacity Test (ASTM F-1798) ●
Overtightening Test (ASTM F-1798) .
Static Torsion Test (ASTM F-1717) .

The results of these tests were compared to the predicate SpineTune TL Spinal System in order to

Indications for Use:

Non-Clinical

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510(k) Summary LDR Spine USA SpineTune TL Spinal System

Spine 3-4 + Spine 4-5 + Spine 5-S1

verify that the proposed screws meet the acceptance criteria set forth by the predicate screws.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe and effective, and performs as well or better than the legally marketed predicate device. Therefore, the data demonstrates that the subject device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" which are arranged in a circular fashion around the eagle.

Public Health Service

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

JUN 2 7 2012

LDR Spine USA, Inc. % Ms. Kiersten Soderman Regulatory Affairs Specialist 13785 Research Boulevard, Suite 200 Austin, Texas 78750

Re: K120760

Trade/Device Name: SpineTune™ TL Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: May 29, 2012 Received: May 30, 2012

Dear Ms. Soderman:

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.

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Page 2 - Ms. Kiersten Soderman

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

LDR Spine SpineTune™ TL Spinal System Device Name: ·

Indications for Use:

Spondylolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective evidence of neurological . impairment
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudoarthrosis .
Failed previous fusion

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 of Surgical . ^ .. ' pedic, and Restorative دينس ت

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.