The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Lateral Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Lateral Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Biomet Lateral Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

As an intervertebral body fusion device, the Biomet Lateral Spacer System 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. When used as an intervertebral body fusion device, the Biomet Lateral Spacer System 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. The Biomet Lateral Spacer System may be implanted via an open or minimally invasive lateral approach.

Device Description

The purpose of this submission is the introduction of a new device for intervertebral body fusion and vertebral body replacement. The Biomet Lateral Spacer System is constructed of medical grade Polyetheretherketone (PEEK-Optima LT1 per ASTM F-2026) and tantalum (per ASTM F-560) radiographic markers, and is available in multiple lengths/widths/heights and lordotic angles to meet varying patient anatomies.

AI/ML Overview

The provided text is a 510(k) Summary for the Biomet Lateral Spacer System, a medical device. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence based on technological characteristics and mechanical performance.

However, the 510(k) Summary does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of typical AI/ML device evaluations. This document details mechanical testing of the device's structural integrity, not a clinical study or evaluation of a diagnostic or predictive AI algorithm's performance against specific clinical or analytical acceptance criteria.

The questions asked (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, ground truth for training set) are highly relevant to the evaluation of AI/ML-driven medical devices, especially those performing diagnostic or assistive functions. These types of details are absent from the provided text.

The Biomet Lateral Spacer System is a physical implant (intervertebral body fusion device), and its "performance data" refers to its mechanical strength and durability as assessed by engineering standards, not its diagnostic accuracy or the effectiveness of an AI component.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text, as the document describes a mechanical device assessment, not an AI/ML device study.

Here's the closest I can get to addressing your request, based on the document's content, while acknowledging the mismatch:

1. Table of "Acceptance Criteria" and Reported Device Performance (as per the document's context):

Acceptance Criteria (Implied by standard)	Reported Device Performance (as stated)
Mechanical strength sufficient for intended use	Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use.

Explanation of the Mismatch:

Acceptance Criteria: For a physical implant, "acceptance criteria" generally refer to meeting specified engineering standards (e.g., load-bearing capacity, fatigue life) under various conditions. The document states that "Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use," implying these acceptance criteria were met, but it doesn't quantify them (e.g., "must withstand X Newtons of force"). It only lists the types of tests conducted (Static Axial Compression, Dynamic Axial Compression, etc.) according to specific ASTM standards (F-2077, F-2267, F-560, F-2026, and an ASTM Draft).
Reported Device Performance: Instead of numerical performance metrics, the document provides a qualitative statement that the device's mechanical strength is "sufficient."

Regarding the other specific questions (2-9):

These questions are designed for AI/ML device studies and are not applicable to the type of device and evaluation described in the provided 510(k) summary.

Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically determined by engineering measurements and adherence to standards, not expert clinical consensus.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study evaluates human reader performance, usually with medical images, often with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm described.
The type of ground truth used: For mechanical testing, the "ground truth" is compliance with engineering specifications and stress tests, not clinical outcomes, pathology, or expert consensus in the diagnostic sense.
The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes the mechanical performance testing of a physical medical implant (Biomet Lateral Spacer System) to demonstrate its safety and effectiveness through substantial equivalence to predicate devices, based on established ASTM engineering standards. It does not contain information relevant to the assessment of an AI/ML medical device, which is what your questions seem to pertain to.

Summary

{0}------------------------------------------------

K 122989

Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font, with each letter connected to the next. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

510(k) Summarv

ОСТ	2	4	2012
-----	---	---	------

Preparation Date:	September 24, 2012
Applicant/Sponsor:	Biomet Spine (aka EBI, LLC)100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Margaret F. Crowe, Regulatory Affairs Project ManagerPhone: 973-299-9300, ext. 2260Fax: 973-257-0232
Trade name:	Biomet Lateral Spacer System
Common Name:	Non-cervical spinal spacerVertebral body replacement
Classification Name:	Intervertebral body fusion device, 21 CFR §888.3080Spinal intervertebral body fixation orthosis, 21 CFR §888.3060
Device Panel/ProductCode:	Orthopedic MAXOrthopedic MQP

Device Description:

Indications for Use:

The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Lateral Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Lateral Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Biomet Lateral Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

Page 5-2

Pg 1 of 3

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font, with each letter connected to the next. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

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 nonoperative treatment. When used as an intervertebral body fusion device, the Biomet Lateral Spacer System 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. The Biomet Lateral Spacer System may be implanted via an open or minimally invasive lateral approach.

Summary of Technologies:

The technological characteristics (material, design and sizing) of the Biomet Lateral Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include:

Expandable PEEK Implant (K082406, K040928) .
ESL Spacer (K092574, K040482) .
Zyston Straight Spacer System (K112014) ●
. Zyston Curve Spacer System (K110650)
. Medtronic Clydesdale Spacer (K083026, K113528)
. NuVasive CoRoent (K071795)
. Synthes Spine Oracle Spacer (K072791)
DePuy Lateral Spacer (K082128, K090899)

Performance Data

Mechanical testing recommended in the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was conducted. The testing conducted, along with the ASTM standard, are listed below:

1. Static Axial Compression (ASTM F-2077)
1. Dynamic Axial Compression (ASTM F-2077)
1. Static Compression-Shear (ASTM F-2077)
1. Dynamic Compression-Shear (ASTM F-2077)
1. Subsidence (ASTM F-2267 and ASTM F-2077)

Additional mechanical testing recommended in the special controls guidance document entitled "Guidance for Industry and FDA Staff: Spinal System 510(k)s" was conducted. The testing conducted, along with the ASTM standard, are listed below:

1. Static Torsion (ASTM F-2077)
1. Dynamic Torsion (ASTM F-2077)
1. Expulsion (ASTM Draft F-04.25.02.02)

Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use.

Page 3-3

Pg 2 of 3

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font, with each letter connected to the next. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

Substantial Equivalence:

The Biomet Lateral Spacer 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 effectiveness. The predicates listed above are distributed for similar indications, and have similar design features.

Page 3-4

Pg 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biomet Spine (AKA EBI, LLC) % Ms. Margaret F. Crowe Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K122989

Trade/Device Name: Biomet Lateral Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 25, 2012 Received: September 26, 2012

OCT 2 4 2012

Dear Ms. Crowe:

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 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

{4}------------------------------------------------

Page 2 - Ms. Margaret F. Crowe

forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eunell Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K1229B9

Device Name: Biomet Lateral Spacer 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carl L-

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

510(k) Number K122969

Page 4-2
Page 1 of 1

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.