The 5.5 Helical Flange 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 lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous 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 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange 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, 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.

Device Description

This submission is a line extension to the EB1 5.5 Helical Flange Spinal System to add new 5.5 Polaris components, which may be used with the other 5.5mm components in order to build various types of spinal constructs. The new components include another style of screws in the larger diameters and a smaller diameter screw.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "EBI 5.5 Helical Flange Spinal System." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through clinical studies with acceptance criteria in the same way one might for a novel diagnostic AI.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This document describes a traditional medical device (spinal fixation system) and its mechanical characteristics, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.

However, I can extract information related to the demonstration of "substantial equivalence" which is the core of this type of submission.

Here's a breakdown of what can be extracted and what is not applicable based on the document:

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

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Material composition	The technological characteristics (material) of the 5.5 components are the same as, or similar to, the predicate devices.
Design	The technological characteristics (design) of the 5.5 components are the same as, or similar to, the predicate devices.
Sizing	The technological characteristics (sizing) of the 5.5 components are the same as, or similar to, the predicate devices.
Intended Use	The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to intended use. It is a non-cervical fixation device intended for immobilization and stabilization as an adjunct to fusion for a range of conditions (e.g., degenerative disc disease, spondylolisthesis, trauma, deformity, tumor, stenosis, pseudarthrosis, failed previous fusion).
Indications for Use	The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to indications. The specific indications listed are comprehensive and match those of the predicate devices for pedicle screw fixation, posterior hook and sacral/iliac screw fixation, and anterolateral fixation.
Technological Characteristics	The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to technological characteristics. Key characteristics like materials, design, and sizing are stated as "same as, or similar to."
Principles of Operation	The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to principles of operation.
Safety and Effectiveness (No New Issues)	The device "do[es] not present any new issues of safety or effectiveness" compared to the predicate devices.
Mechanical Testing Performance	Based upon "mechanical testing," the 5.5 Helical Flange Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market. (Specific performance values or acceptance thresholds for mechanical testing are not detailed in this summary, but are implied to be met to demonstrate equivalence).

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

Not Applicable. This document describes a mechanical device, not a diagnostic algorithm. The "test set" in this context would refer to mechanical testing (e.g., fatigue testing, static strength testing of the implants), not a clinical data set. The document states "Based upon the mechanical testing," but does not provide details on the sample size, specific tests, or provenance of the data.

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. Ground truth in the context of diagnostic AI refers to a definitive correct answer for a medical condition. For a spinal implant, "ground truth" would relate to the mechanical integrity and biocompatibility, which are verified through engineering tests and material science, not by expert medical interpretation of images or patient outcomes in this type of submission.

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

Not Applicable. Adjudication methods are used in studies involving subjective interpretation, often by multiple readers, to establish a consensus ground truth. This is not relevant for the type of mechanical testing described in this 510(k) summary.

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. MRMC studies are specific to diagnostic performance, often for AI-assisted workflows. This document is for a spinal fixation system, not a diagnostic AI.

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

Not Applicable. This is not an algorithm or AI device.

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

The "ground truth" for a medical implant like this is typically established through adherence to recognized industry standards for mechanical testing (e.g., ASTM standards for spinal implants) and biocompatibility testing (though not explicitly detailed in this summary, it's a prerequisite for such devices). The summary mentions "mechanical testing" as the basis for substantial equivalence, implying these standards were met. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for an AI diagnostic.

8. The sample size for the training set

Not Applicable. This device is a mechanical implant, not an AI. There is no concept of a "training set" in this context.

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

Not Applicable. As there is no training set for a mechanical implant, this question is not relevant.

Summary

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JUL 6 u 2009

Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

510(k) Summa

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

Preparation Date:	July 2, 2009
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyPhone: 973-299-9300 x2214Fax: 973-257-0232
Trade name:	EBI 5.5 Helical Flange 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:

Indications for Use:

The 5.5 Helical Flange Spinal System is a non-cervical 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 indivations: 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.

The 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative discogenic back pain with degencration 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, sternosis, 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 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for

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K090203 Page 2 of 2

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., scollosis, 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.

Summary of Technologies:

The technological characteristics (material, design and sizing) of the 5.5 components are the same as, or similar to, the predicate devices.

Substantial Equivalence:

The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or ell'ectiveness. Examples of predicates include EBI's Helical Flange Spinal Systems (K061441 & K041449), the Synergy Spinal System (K011437 & K081952) and the Array Spinal System (K061563). Based upon the mechanical testing, the 5.5 Helical Flange Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and vigilance. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EBI, L.P. % Ms. Vivian Kelly Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054

JUL 30 2009

Re: K090203

Trade/Device Name: EB10 5.5 Helical Flange Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: July 1, 2009 Received: July 2, 2009

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.

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

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Page 2 -- Ms. Vivian Kelly

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Wilkerson

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): K090203

Device Name: EBI® 5.5 Helical Flange Spinal System

Indications for Use:

The 5.5 Helical Flange 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., tracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative disc disease (defined as discogenic back pain with the following indications: 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 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange 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 contirmed 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR . (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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2-2 (ExT for mxou)

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

510(k) Number: K090203

Page 11

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.