The Libra Pedicle Screw System is intended for immobilization of the posterior thoracic, lumbar and sacral/iliac spine (T1-S1/Ilium) in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Device Description

The Libra Pedicle Screw System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

AI/ML Overview

This document is a 510(k) premarket notification for the "Libra Pedicle Screw System," specifically for adding a cobalt chrome rod series. It does not contain information about a study proving the device meets acceptance criteria in the way a clinical trial or algorithm performance study would. The acceptance criteria and "study" are related to demonstrating substantial equivalence to a predicate device through non-clinical performance data (e.g., theoretical analysis).

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only discusses "performance data" in the context of demonstrating substantial equivalence, not specific quantitative acceptance criteria with reported numerical performance values like sensitivity/specificity for a diagnostic device. The acceptance criterion is essentially "does not create a new worst case" or "maintains existing performance."

Acceptance Criteria	Reported Device Performance
Mechanical Performance: The cobalt chrome rod, when integrated into the Libra Pedicle Screw System, should not create a new worst-case scenario compared to the previously cleared titanium alloy rods. This implies that the mechanical properties and system integrity should be maintained or improved, and not compromised.	Theoretical analysis of the proposed device modification was performed. The results demonstrate the cobalt chrome rod does not create a new worst case.
Material Biocompatibility: The new material (cobalt chrome) should be medically acceptable and suitable for implantation.	Rods are additionally manufactured from cobalt chrome (ASTM F1537). (This implies compliance with a recognized standard, which serves as an acceptance criterion for material safety/biocompatibility).
Technological Characteristics: The overall system should retain the same intended use, basic design, dimensions, and fundamental scientific technology as the predicate device.	The Libra Pedicle Screw System possesses the same technological characteristics as the predicate device, including intended use, basic design (rod and screw configuration), material (medical grade), and sizes. The fundamental scientific technology is the same as the previously cleared device.

2. Sample size used for the test set and the data provenance

Not applicable in the context of a clinical study. The "test set" here refers to the theoretical analysis performed on the design of the cobalt chrome rod and its integration into the system. It's a theoretical analysis, not a study involving human subjects or a large dataset. No data provenance in the sense of patient data is mentioned, as this is a materials/mechanical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context would refer to established engineering principles, material science standards (e.g., ASTM F1537), and possibly expert engineering analysis to determine if the new component "does not create a new worst case." The document does not specify the number or qualifications of experts involved in this theoretical analysis, but it would typically be conducted by qualified engineers and material scientists within Spinal Balance, Inc. or their consultants.

4. Adjudication method for the test set

Not applicable. There's no mention of an adjudication method as would be used for image review or clinical assessments. The "adjudication" is inherent in the internal engineering review and FDA's assessment of the 510(k) submission.

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 device is a pedicle screw system for spinal fusion, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" used for this type of submission would be established engineering principles, material science standards (e.g., ASTM F136 for titanium, ASTM F1537 for cobalt chrome), and biomechanical testing standards (though direct testing results are not detailed here, theoretical analysis relies on such principles). The "ground truth" for showing substantial equivalence is that the new material change does not negatively impact the safety and effectiveness profile of the already cleared device, as assessed through engineering analysis.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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

October 27, 2016

Spinal Balance, Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting, Inc. P.O. Box 566 Chesterland, Ohio 44026-0566

Re: K162750

Trade/Device Name: Libra Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: September 28, 2016 Received: September 30, 2016

Dear Dr. Warden:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K162750

Device Name Libra Pedicle Screw 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)

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)

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Section 8 – 510(k) Summary

Date:	28 September 2016
Sponsor:	Spinal Balance, Inc.Nitschke Technology Commercialization Complex (NTCC)1510 N. Westwood AveToledo OH 43606440.530.5940
Sponsor Contact:	Anand Agarwal, MD, President and CEO
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting, Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Proposed Trade Name:	Libra Pedicle Screw System
Common Name:	Posterior pedicle screw system
Device Classification:	Class III
Classification Name:	Pedicle screw spinal system
Regulation:	888.3070
Device Product Code:	NKB, MNI, MNH
Submission Purpose:	To add a cobalt chrome rod series to the Libra Pedicle Screw Systemimplant offering.
Device Description:	The Libra Pedicle Screw System consists of longitudinal members (rods),anchors (screws) and fasteners in a variety of sizes to accommodatediffering anatomic requirements.
Indications for Use:	The Libra Pedicle Screw System is intended for immobilization andstabilization of the posterior thoracic, lumbar and sacral/iliac spine (TI-S1/Ilium) in skeletally mature patients as an adjunct to fusion for thefollowing indications: degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fracture ordislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, orlordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Materials:	Libra components are manufactured from Ti-6Al-4V ELI titanium alloy(ASTM F136). Rods are additionally manufactured from cobalt chrome(ASTM F1537).
Predicate Device:	Primary: Libra Pedicle Screw System (Spinal Balance, Inc. – K151770)
Performance Data:	Theoretical analysis of the proposed device modification was performed.The results demonstrate the cobalt chrome rod does not create a new worstcase.
TechnologicalCharacteristics:	The Libra Pedicle Screw System possesses the same technologicalcharacteristics as the predicate device. These include:intended use (as described above) basic design (rod and screw configuration) material (medical grade) sizes (dimensions are comparable to those offered by the predicate systems) andThe fundamental scientific technology of the Libra Pedicle Screw System isthe same as previously cleared device.

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The Libra Pedicle Screw System possesses the same intended use and Conclusion: technological characteristics as the predicate devices. Therefore Libra Pedicle Screw System is substantially equivalent for its intended use.

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.