The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.

In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.

AI/ML Overview

This document is a 510(k) Summary for the OLYMPIC Posterior Spinal Fixation System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices primarily based on non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it lists the types of non-clinical tests performed and states a general conclusion of equivalence to predicate devices. The "acceptance criteria" are implied by the standards cited for each test.

Test Type	Standard	Reported Device Performance / Outcome
Finite Element Analysis	(Not a specific ASTM standard listed for FEA)	Determined worst case for testing
Static Compression Bending	ASTM F1717	"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
Dynamic Compression Bending	ASTM F1717	"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
Static Torsion	ASTM F1717	"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
Axial grip	ASTM F1798	"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
Torsional grip	ASTM F1798	"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
Corrosion testing	ASTM F2129	"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."

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 for Test Set: Not applicable as the study involved non-clinical bench testing rather than human or animal subjects. The "test set" here refers to the physical device components and constructs subjected to mechanical testing. The specific number of samples for each test (e.g., how many constructs were tested for static bending) is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on actual device components. The location where these tests were conducted is not specified, but the applicant (Astura Medical, LLC) is based in Carlsbad, CA, USA.

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)

Not applicable. This study is a non-clinical, mechanical performance evaluation of a spinal fixation system. "Ground truth" in the sense of expert clinical consensus or pathology is not relevant for this type of testing. The performance is measured against engineering standards (ASTM).

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

Not applicable. As this is a non-clinical, mechanical testing study, there is no adjudication of findings by experts. The results are objective measurements against defined 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

No. This document explicitly states: "No clinical studies were performed." Therefore, an MRMC study related to AI assistance is not relevant.

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

No. This device is a physical spinal implant, not a software algorithm or AI device.

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

The "ground truth" for the non-clinical tests are the established mechanical performance requirements and limits defined by the cited ASTM standards. The device's performance is compared against the performance of predicate devices and the requirements of these standards to demonstrate substantial equivalence, not against clinical expert consensus or pathology data.

8. The sample size for the training set

Not applicable. There is no training set for this device, as it is a physical medical implant and not an AI/ML algorithm.

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

Not applicable. There is no training set.

Summary

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Image /page/0/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 a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and connection.

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

April 8, 2016

Astura Medical, LLC % Mr. J.D. Webb Authorized Contact Person The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K153446

Trade/Device Name: OLYMPIC Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, MNI, MNH Dated: March 9, 2016 Received: March 10, 2016

Dear Mr. Webb:

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 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/ResourcesforYou/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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153446

Device Name

OLYMPIC Posterior Spinal Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X | 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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510(k) Summary: OLYMPIC Posterior Spinal Fixation System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date Prepared	April 5, 2016
Submitted By	Astura Medical, LLC5670 El Camino Real, Suite BCarlsbad, CA 92008760-814-8047 Tele
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	OLYMPIC Posterior Spinal Fixation System
Common Name	pedicle screw system
Classification Name	Pedicle screw spinal system
Class	II
Product Code	OSH - Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisMNI - Orthosis, Spinal Pedicle FixationMNH - Orthosis, Spondylolisthesis Spinal Fixation
CFR Section	21 CFR section 888.3070
Device Panel	Orthopedic
Primary PredicateDevice	Revere®/CREO™ Stabilization System - Globus Medical (K143633)
Secondary PredicateDevices	Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748)Expedium/Viper - DePuy Spine (K111136 / K131802)Universal Spinal System / Matrix - Synthes (K111358 / K100952)Moss Miami SS - DePuy Spine (K000536), Ti-6AI-4V (K955348)Synergy VLS - open - Cross Medical (K940631 / K950099)PWB (now Synergy) - Cross Medical (K920116)Polyaxial LP - Scient'x (K062912)Vectra System - Synthes (K050451)VERTEX Reconstruction System - Medtronic (K093434)
Device Description	The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar,sacral, and iliac fixation system implanted from the posterior approach anddesigned to provide fixation during the fusion process. The system is composedof preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rodconnectors. The system is supported by a comprehensive set of instruments toinstall the implants within the system.
Materials	Ti-6Al-4V ELI (ASTM F136)CP Titanium Grade 4 (ASTM F37)CoCr alloy (ASTM F1537)Elgiloy CoCrNi alloy (ASTM F1058)Nitinol #1 (ASTM F2063)
SubstantialEquivalence Claimedto Predicate Devices	The OLYMPIC Posterior Spinal Fixation System is substantially equivalent to thepredicate devices in terms of intended use, design, materials used, mechanicalsafety and performances.
Indications for Use	The OLYMPIC Posterior Spinal Fixation System is intended to provideimmobilization and stabilization of spinal segments in skeletally mature patientsas an adjunct to fusion in the treatment of the following acute and chronicinstabilities or deformities of thoracic, lumbar, and sacral spine (T1-S2/ilium):degenerative spondylolisthesis with objective evidence of neurologicalimpairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis,kyphosis, and/or lordosis), spinal tumor, and failed previous fusion(pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC PosteriorSpinal Fixation System is intended to be used with autograft/allograft.In addition, the OLYMPIC Posterior Spinal Fixation System is intended fortreatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra inskeletally mature patients receiving fusion by autogenous bone graft, havingimplants attached to the lumbosacral spine and/or ilium with removal of theimplants after the attainment of a solid fusion. Levels of pedicle screw fixation forthese patients are L3-sacrum/ilium.When used for posterior non-cervical pedicle screw fixation in pediatric patients,the OLYMPIC Posterior Spinal Fixation System implants are indicated as anadjunct to fusion to treat adolescent idiopathic scoliosis. The OLYMPIC PosteriorSpinal Fixation System is intended to be used with autograft and/or allograft.Pediatric pedicle screw fixation is limited to a posterior approach.
Non-clinical TestSummary	The following analyses were conducted:Finite Element Analysis to determine worst case for testing Static Compression Bending - ASTM F1717 Dynamic Compression Bending - ASTM F1717 Static Torsion - ASTM F1717 Axial grip - ASTM F1798 Torsional grip - ASTM F1798 Corrosion testing - ASTM F2129 The results of these evaluations indicate that the OLYMPIC Posterior SpinalFixation System is equivalent to the predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Astura Medical considers OLYMPIC Posterior Spinal Fixation System to beequivalent to the predicate devices listed above. This conclusion is based uponthe devices' similarities in principles of operation, technology, materials andindications for use

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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.