The PEEK-OPTIMA® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Device Description

The PEEK-OPTIMA® ALIF Spacer is a contoured device constructed of Polyetheretherketone (PEEK) medical grade, for spinal applications, inserted into the intervertebral body space of the lumbosacral spine for intervertebral body fusion.

AI/ML Overview

This 510(k) summary describes a medical device, the PEEK-OPTIMA® ALIF Spacer, which is an intervertebral body fusion device. The document focuses on establishing substantial equivalence to previously cleared predicate devices through a comparison of device characteristics and mechanical testing.

Crucially, this document does not describe acceptance criteria, performance data, or a study related to the device's diagnostic or predictive capabilities. Since this is an implantable surgical device, its approval is based on its material properties, design, indications for use aligning with established medical practices, and demonstrable substantial equivalence to already approved devices through mechanical testing. The information provided in the prompt is specific to diagnostic or AI-driven medical devices, which is not applicable here.

Therefore, I cannot populate the table or answer the questions as the provided document does not contain information about acceptance criteria, device performance metrics, sample sizes for testing sets, ground truth establishment, expert adjudication, or any form of clinical study comparing reader performance with or without AI assistance.

The document's purpose is to demonstrate that the PEEK-OPTIMA® ALIF Spacer is substantially equivalent to existing, legally marketed predicate devices based on:

Intended Use: For intervertebral body fusion in the lumbar spine for patients with degenerative disc disease.
Design: A contoured device for intervertebral body space.
Materials: Constructed of PEEK (Polyetheretherketone) medical grade.
Operational Principles: Functions as a spacer to facilitate fusion with autograft and supplemental fixation.
Mechanical Testing: The document states that "Based upon the mechanical testing, the PEEK ALIF is substantially equivalent for its intended use to other spacers currently on the market." (Specific details of the mechanical testing, including acceptance criteria and results, are not provided in this summary but would have been part of the full 510(k) submission).

In summary, the provided text describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, primarily through material and design characteristics, and mechanical testing, rather than algorithmic performance evaluation.

Summary

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510(K) Summa

AUG - 7 2008

Preparation Date:	July 30, 2008
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyPhone: 973-299-9300 x2214Fax: 973-257-0232
Trade name:	PEEK-OPTIMA® ALIF Spacer
Common Name:	Intervertebral body fusion device
Classification Name:	Intervertebral fusion device, 21 CFR §888.3080
Device Panel /Product Code:	Orthopedic MAX

Device Description:

Indications for Use:

The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Summary of Technologies:

The technological characteristics (material, design and sizing) of the PEEK-OPTIMA® ALIF Spacer are the same as, or similar to, the predicate devices.

Substantial Equivalence:

The PEEK-OPTIMA® ALIF Spacer is substantially equivalent to its predicates for intervertebral body fusion in regards to intended use, design, materials, and operational principles. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFix™-LR (K072253) while the Interpore Cross Expandable PEEK VBR Implant (K040928) has similar design features. Based upon the mechanical testing, the PEEK ALIF is substantially equivalent for its intended use to other spacers currently on the market.

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Image /page/1/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 an abstract symbol that resembles an eagle or bird in flight, rendered in a stylized, minimalist design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Spine % Ms. Vivian Kelly Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054

AUG - 7 2008

Re: K081636

Trade/Device Name: PEEK-OPTIMA® ALIF Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: June 10, 2008 Received: June 11, 2008

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 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. Vivian Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours.

Mark N. Milliman

Mark N. Melkerson 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): K081636

Device Name: PEEK-OPTIMA® ALIF Spacer

Indications for Use:

The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Barbara Bueno

al. Restorative, Division of Gener and Neurological Devices

510(k) Number K081636

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.