The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac serew fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patiens. The device is indicated for all of the following indications regardless of the intended use; 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/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EBI® Array® Spinal System. This submission is for a medical device (spinal fixation system), not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test and training sets, expert consensus, MRMC studies, standalone performance) is not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing.

Here's a breakdown of the relevant information from the provided text:

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

Acceptance Criteria (Design Specifications)	Reported Device Performance
Conformance to design specifications based on predicate devices.	Mechanical testing demonstrates that the proposed line extension conforms to its design specifications.
Adequacy of mechanical performance in "worst case" scenarios.	Results of testing demonstrate that the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance.
No new issues of safety or effectiveness compared to predicate devices.	Mechanical testing demonstrated that technological differences (line extension) do not present any new issues of safety or effectiveness.

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

Not applicable for this type of submission. This submission is for a spinal fixation device, relying on mechanical testing to demonstrate substantial equivalence, not the analysis of patient 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 this context would refer to material properties and mechanical behaviors, established through standardized engineering tests, not clinical expert consensus on images or diagnoses.

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

Not applicable. Adjudication methods are relevant for clinical interpretations, not mechanical testing. Mechanical tests have objective, measurable 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:

Not applicable. This submission is not for an AI-assisted diagnostic device.

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

Not applicable. This submission is not for an AI algorithm.

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

The "ground truth" for this device's performance is established by engineering design specifications and standards for mechanical properties and structural integrity of spinal fixation devices, derived from predicate devices. The tests measure objective physical properties and behaviors under defined loads.

8. The sample size for the training set:

Not applicable. This submission does not involve a training set for an AI model.

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

Not applicable. This submission does not involve a training set for an AI model.

Summary of the Study (Mechanical Performance Testing):

The device's performance was evaluated through mechanical testing. This testing was conducted to demonstrate that the expanded line of the Array® Spinal System conforms to its design specifications, which were themselves based on the design requirements of previously cleared predicate devices. The study focused on demonstrating that "the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance." The conclusion was that "these technological differences do not present any new issues of safety or effectiveness."

Summary

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K062685

	EBI, L.P./Biomet SpineArray® Spinal System	OCT - 6 2006
SUBMITTER:	EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054
SUBMISSION PREPARED BY:	Jennifer P. HarakalRegulatory Affairs Specialist
CONTACT PERSON:	Debra BingRegulatory Affairs DirectorPhone: 973-299-9300 x3964Fax: 973-257-0232
DATE PREPARED:	September 7, 2006
TRADE NAME:	Array® Spinal System
COMMON NAME:	Spinal Fixation Device
CLASSIFICATION NAME:	Spondylolisthesis Spinal Fixation DeviceSpinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation Orthosis
PRODUCT CODE:	NKB, MNH, MNI, KWQ, KWP
CLASS:	Class III
REGULATION NUMBER:	21 CFR 888.3050, 21 CFR 888.3070,21 CFR 888.3060
PREDICATE DEVICES:	EBI® Array® Spinal System (Stainless Steel), K061563
	EBI® Array® Spinal Fixation System, K033312(formerly referred to as 'Top Loading MAS SpinalFixation System')
	EBI® Webb Morley Spine System, K941367

INTENDED/INDICATIONS FOR USE:

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TECHNOLOGICAL CHARACTERISTICS:

Performance Testing

Mechanical testing of the Array® Spinal System was conducted and demonstrates that the proposed line extension conforms to its design specifications. The design requirements were established based on those of the previously cleared predicate devices. The results of testing conducted demonstrate that the worst case of the proposed system adequetely meets the requirements established in design specifications for its mechanical performance.

Substantial Equivalence

The Array® Spinal System is substantially equivalent to other legally marketed spinal fixation devices with respect to intended use and indications, technological characterstitiss, and basic principles of operation. This premarket notification is being submitted to address a line extension to the existing Array Spinal System. As demonstrated by mechanical testing, these technological differences do not present any new issues of safety or effectiveness.

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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2006

EBI, L.P. % Ms. Debra Bing Regulatory Affairs Director 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K062685

Trade/Device Name: EBI® ARRAY® 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: September 7, 2006 Received: September 8, 2006

Dear Ms. Bing:

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 such 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); 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.

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Page 2 – Ms. Debra Bing

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and hyp of substantial equivalence of your device of your device to a legally premainer nodicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours,

Salvega Bucland

Tark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: EBI® Array® Spinal System

Indications for Use:

The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; 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/or lordosis), turnor, stenosis, pseudarthrosis, and failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter

(21 C.F.R. 807 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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Oarbare Buchyn

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K062685

Regulation Number and Section

N/A