The LEUCADIA AUTOLOK™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor, pseudarthrosis; and/or failed previous fusion.

Device Description

The Leucadia AutoLok™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Multi-axial AutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diameter sizes. All sizes can receive 5.5mm connecting rods only. The unique pedicle screw and set screw interface is designed to prevent backout of the set screw from the construct. The Leucadia AutoLok™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia AutoLok™ Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia AutoLok™ Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia AutoLok™ Pedicle Screw System components should not be reused.

AI/ML Overview

The LEUCADIA AUTOLOK™ Pedicle Screw System is a medical device. The provided text describes its indications for use and mentions biomechanical tests performed to demonstrate its equivalence to predicate devices. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI-powered device.

Here's a breakdown of what can be extracted from the given text and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

Acceptance Criteria	Reported Device Performance
Biomechanical performance according to ASTM F1717-15 for Static Compression Bending, Static Torsion, and Dynamic Compression Bending.	The test results were equivalent to the predicate device(s) and other similar implants legally marketed and are sufficient for in vivo loading.

Missing Information: The specific quantitative acceptance criteria (e.g., specific load thresholds, displacement limits) stated in ASTM F1717-15 are not detailed in this document. The document only states that the device's performance was "equivalent" and "sufficient."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not specified for the biomechanical tests. Biomechanical tests typically use a determined number of test articles for each test condition.
Data Provenance: Not specified. Biomechanical tests are conducted in a laboratory setting, not typically based on patient data provenance.

3. 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):

This question is not applicable to the provided information. The document describes a traditional medical device (pedicle screw system), not an AI-powered diagnostic or decision support device. Biomechanical testing for such devices does not involve expert readers or establishing ground truth based on their interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable for the same reason as point 3.

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:

This question is not applicable for the same reason as point 3.

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

This question is not applicable as this is not an AI-powered device. The device itself (pedicle screw system) is a standalone implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this type of device, the "ground truth" for proving performance is established through biomechanical testing standards (ASTM F1717-15 in this case). The "truth" is that the device meets the physical and mechanical requirements defined by these standards, which are considered sufficient for in vivo loading.

8. The sample size for the training set:

This question is not applicable as this is not an AI-powered device that requires a training set.

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

This question is not applicable as this is not an AI-powered device that requires a training set or ground truth in that context.

Summary

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December 12, 2018

ClearView Orthopedic Development, LLC Mr. Hartmut Loch Vice President, Regulatory Affairs & Quality Assurance 15550-D Rockfield Boulevard Irvine, California 92618

Re: K182339

Trade/Device Name: LEUCADIA AUTOLOK™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 7, 2018 Received: November 13, 2018

Dear Mr. Loch:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -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) K182339

Device Name LEUCADIA AUTOLOK™ Pedicle Screw System

Indications for Use (Describe)

The LEUCADIA AUTOLOK™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions:

Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor, pseudarthrosis; and/or failed previous fusion.

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)

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Contact:	Mr. Hartmut Loch, RACVice President, Regulatory Affairs & Quality AssuranceClearView Orthopedic Development, LLC15550-D Rockfield BlvdIrvine CA 92618Tel: 1-949-752-7885 x 104Fax: 1-949-752-7886
Date Prepared:	December 11, 2018
Trade name:	LEUCADIA AutoLok™ Pedicle Screw System
Common name:	Spinal Fixation System
Classificationname:	§ 888.3070 - Thoracolumbosacral Pedicle Screw System (NKB)
Regulatory Class:	II
Device Panel:	Orthopedic Device Panel 87
Product Code(s):	NKB
Device Descriptionand Characteristics:	The Leucadia AutoLok™ Pedicle Screw System is intended to help providecorrection, immobilization and stabilization of spinal segments as an adjunctto fusion of the thoracic, lumbar and/or sacral space.The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rodsand screws, which can be rigidly locked into a variety of configurations, witheach construct being tailor made for the individual case. The Multi-axialAutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diametersizes. All sizes can receive 5.5mm connecting rods only. The uniquepedicle screw and set screw interface is designed to prevent backout of theset screw from the construct. The Leucadia AutoLok™ Pedicle ScrewSystem implant components are fabricated from medical grade titanium alloy(Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent.The Leucadia AutoLok™ Pedicle Screw System is a temporary implantsystem, intended to be removed after solid fusion has occurred. LeucadiaAutoLok™ Pedicle Screw System implant components should not be usedwith components from any other system or manufacturer. As with allorthopedic implants, Leucadia AutoLok™ Pedicle Screw Systemcomponents should not be reused.
Indications:	The LEUCADIA AUTOLOK™ Pedicle Screw System is intended to be usedas an adjunct to fusion using autograft or allograft in posterior, non-cervicalfixation for the following conditions: degenerative disc disease (defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies); spondylolisthesis; trauma (i.e. fracture ordislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/orlordosis); tumors; pseudarthrosis; and/or failed previous fusion.
Equivalence:	The modified LEUCADIA AUTOLOK™ Pedicle Screw System issubstantially equivalent to the following marketed systems:1. Leucadia AutoLok™ Pedicle Screw System K113366 S/E 1/17/2012(Primary)2. Leucadia Pedicle Screw System K103102 S/E 2/8/2011 (Additional)3. Leucadia Pedicle Screw System K110588 S/E 5/25/2011(Additional)They are all manufactured and marketed by ClearView OrthopedicDevelopment, LLC, formerly Phygen, LLC.
	The subject System has been slightly redesigned, regarding the lockinginterfaces between the pedicle screw, the AutoLok™ pedicle screw head andthe AutoLok™ set screw/locking nut in order to assure maximum stability ofthe construct under worst case tolerances.
	The indications for use, sizes and varieties of components, materials, type ofsterilization, surgical techniques, and manufacturing processes have notchanged and are identical to the predicate device (s).
Performance data:	Biomechanical tests according to ASTM F1717-15 (Static CompressionBending, Static Torsion, and Dynamic Compression Bending) have beenperformed. The test results were equivalent to the predicate device(s) andother similar implants legally marketed and are sufficient for in vivo loading.

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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.