The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all 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), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The Accu Vision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

Device Description

This submission is a line extension to Polaris Spinal System to add 6.35 titanium uniplanar screws to the system.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Biomet Spine Polaris Spinal System, specifically a line extension to add 6.35 titanium uniplanar screws. This document focuses on demonstrating substantial equivalence to existing predicate devices through mechanical testing, rather than presenting a study of an AI/ML device meeting acceptance criteria.

Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable to this document.

Here's an analysis based on the provided text, focusing on the mechanical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that mechanical testing was conducted "in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004." It also mentions "ASTM 1717-04, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model."

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Meets mechanical test requirements based on ASTM 1717-04 for static compression bending, static torsion, and dynamic compression bending fatigue.	"met all mechanical test requirements based on the worst-case construct testing."
Substantially equivalent to other spinal systems currently on the market regarding mechanical performance.	"verifies that the subject device is substantially equivalent to other spinal systems currently on the market"

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

The document does not specify the exact sample size for the mechanical tests. It refers to "worst-case construct testing," implying that representative samples of the new 6.35 titanium uniplanar screws within the Polaris Spinal System were tested.

Sample Size: Not explicitly stated, but based on "worst-case construct testing" in accordance with industry standards.
Data Provenance: The testing was conducted by Biomet Spine or a contracted lab, likely in the United States (given the applicant's address and FDA submission). It is a prospective test specifically designed to support the 510(k) submission for the new components.

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

This question is not applicable as the "ground truth" for mechanical testing is defined by established engineering standards (ASTM 1717-04) and FDA guidance for spinal systems, not expert human interpretation. The "ground truth" in this context is whether the physical properties of the device meet the specified mechanical performance thresholds.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical tests are objective measurements against defined criteria. There is no human adjudication process in the same way there would be for image interpretation or clinical outcomes.

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. This is a submission for a medical device (spinal fixation system), not an AI/ML diagnostic or assistive tool.

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

This question is not applicable. This is a submission for a medical device (spinal fixation system), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is mechanical endurance and strength defined by established industry standards (ASTM 1717-04) and FDA guidance for spinal systems. The device must meet these predefined physical performance specifications to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical testing for a physical medical device.

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

This question is not applicable. Similarly, there is no "training set" or corresponding ground truth establishment process in this context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The logo is in black and white and features the word "BIOMET" in large, bold letters. Below the word "BIOMET" is the word "SPINE" in smaller letters. The logo is simple and modern.

FEB - 2 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	November 9, 2010
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyPhone: 973-299-9300 x2214Fax: 973-257-0232
Trade name:	Polaris Spinal System
Common Name:	Non-cervical spinal fixation system
Classification Name(Product Code):	Posterior, noncervical, nonpedicle use (KWP)Anterior/anterolateral noncervical use (KWQ)Noncervical pedicle applications (MNI, MNH and NKB)
Device Panel - Regulation No.:	Orthopedic - 21 CFR 888.3050, 888.3060 and 888.3070

Device Description:

1103393

This submission is a line extension to Polaris Spinal System to add 6.35 titanium uniplanar screws to the system.

Indications for Use:

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of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

Summary of Technologies:

The technological characteristics of the new components are the same as, or similar to, the predicate devices.

Performance Data:

K103293

Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff -Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: static compression bending, static torsion and dynamic compression bending fatigue per ASTM 1717-04, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. The mechanical testing verifies that the subject device is substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing.

Substantial Equivalence:

The 6.35 titanium uniplanar screws in the Polaris Spinal System are substantially equivalent to the other screws in Polaris Spinal System cleared in K090523, K011437, K041449 K081952 and K 100220. These new screws are substantially equivalent to the predicate screws with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness.

Conclusion:

The subject device is substantially equivalent to its predicates when used as a spinal fixation device. The indications for use and fundamental technology of the device remain unchanged. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject device to the other components in the Polaris Spinal System. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 graphic of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biomet Spine % Ms. Vivian Kelly 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K103393

FEB - 2 201

Trade/Device Name: Polaris Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: January 05, 2011 Received: January 06, 2011

Dear Ms. Kelly:

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

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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.

ACy B.D.h

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 K10339 510(k) Number (if known):

Device Name: Polaris Spinal System

Indications for Use:

. )

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all 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), deformity or curvature (i.e., scoliosis, and fordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The AccuVision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for 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), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical. Orthopedic,
and Restorative Devices

510(k) Number	K103393
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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.