The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels L1 through S1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondyloysis, spondylolisthesis, stenosis and/or failed previous fusion.

Device Description

The Biomet Anterior Lumbar Plate System consists of a titanium alloy plate and bone screws. The plates are available with two different lordotic curves for the lumbar or lumbosacral regions. Plates will be available in different lengths. The plates have threaded holes to accommodate bone screws, which will be available in different diameters and lengths.

AI/ML Overview

This document is a 510(k) summary for the Biomet Anterior Lumbar Plate System, a medical device for spinal fixation. It establishes substantial equivalence to predicate devices based on technological characteristics and mechanical testing.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

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

The document does not explicitly define "acceptance criteria" through numerical thresholds or specific performance metrics in the way a typical diagnostic device study would. Instead, the "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Implicit for 510(k) via Substantial Equivalence):
- Similar intended use and indications.
- Similar technological characteristics.
- Similar principles of operation.
- No new issues of safety or effectiveness.
- Demonstrated mechanical performance equivalent to predicate devices.
Reported Device Performance:
- The Biomet Anterior Lumbar Plate System consists of a titanium alloy plate and bone screws.
- Plates are available with two different lordotic curves and different lengths.
- Screws are available in different diameters and lengths.
- The document states, "Based upon the mechanical testing, the Biomet Anterior Lumbar Plate is substantially equivalent for its intended use to other spinal systems currently on the market." This is the primary statement of its performance being "accepted" in the context of the 510(k) process.

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

Test Set Sample Size: The document does not specify a "test set" in terms of patient data or a specific number of devices tested. The evaluation is based on "mechanical testing" of the device itself, likely involving a representative sample of plates and screws. The exact sample size for this mechanical testing is not provided.
Data Provenance: Not applicable in the traditional sense of patient data. The "mechanical testing" would have been conducted by the manufacturer, Biomet Spine. No country of origin for this data is specified, but the applicant's address is Parsippany, NJ, USA. The testing would be prospective in the sense that it was performed specifically for this submission.

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)

This information is not provided and is generally not relevant for this type of device (spinal implant) in a 510(k) submission. The "ground truth" for a mechanical device is its physical and mechanical properties, assessed through standardized engineering tests, not expert interpretation of clinical data.

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

This information is not provided and is not relevant. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple experts. For mechanical testing, the "adjudication" is generally based on objective measurements and comparison to predefined engineering standards or predicate device performance.

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 MRMC study was done. This document pertains to a physical medical device (spinal implant), not an AI/software device whose performance depends on human readers. Therefore, this section is not applicable.

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

No standalone algorithm performance study was done. This document is for a physical medical device, not a standalone AI algorithm. Therefore, this section is not applicable.

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

The "ground truth" for this device's performance evaluation in the 510(k) process is its mechanical properties (e.g., strength, fatigue resistance, torsional stability) determined through standard engineering tests. These properties are then compared to those of legally marketed predicate devices to establish substantial equivalence. No clinical ground truth (like pathology or outcomes data) is explicitly mentioned for the 510(k) summary itself, as robust clinical trials are often not required for 510(k) clearance if substantial equivalence can be demonstrated through other means (like mechanical testing and comparison of design).

8. The sample size for the training set

No training set is applicable or mentioned. This is a physical medical device, not a machine learning model.

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

Not applicable. As there is no training set mentioned or relevant for this type of device, the ground truth for it would not be established.

Summary

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Image /page/0/Picture/0 description: The image shows the text "Ko 82187" in a handwritten style. The characters are bold and slightly uneven, giving them a casual appearance. The text appears to be a code or identifier, possibly a serial number or a reference code.

Image /page/0/Picture/1 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.

NOV 1 3 2008

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 11, 2008
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyPhone: 973-299-9300 x2214Fax: 973-257-0232
Trade name:	Biomet Lumbar Plate System
Common Name:	Lumbar spinal fixation system
Classification Name -Product Code:	Spinal intervertebral body fixation orthosis - KWQ
Device Panel - Regulation No .:	Orthopedic - 21 CFR 888.3060

Device Description:

Indications for Use:

The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels L1 through S1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondylovsis, spondylolisthesis, stenosis and/or failed previous fusion,

Summary of Technologies:

The Biomet Anterior Lumbar Plate System has similar technologics to the predicate devices.

Substantial Equivalence:

The Biomet Lumbar Plate 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 effectiveness. Example of predicates include Synthes Anterior Tension Band (ATB) System (K022791), Zimmer Trinica® Anterior Lumbar Plate System (K061353) and EBI's Top Loading MAS Spinal Fixation System (K033312). Based upon the mechanical testing, the Biomet Anterior Lumbar Plate is substantially equivalent for its intended use to other spinal systems currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2008

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

Re: K082187

Trade/Device Name: Biomet Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: II Product Codc: KWQ Dated: November 03, 2008 Received: November 05, 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, MS, RAC

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 the reporting 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 M. Milligan

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

510(k) Number (if known): K082187

Device Name: Biomet Anterior Lumbar Plate System

Indications for Use:

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)

Neil Rephle for axn

Page 1 of 1

(Division Division of General. Restorative, and Neurological Devices

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510(k) Number K082187

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.