The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal 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 ESL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal 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.

As an intervertebral body fusion device, the ESL® Spinal 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 nonoperative treatment.

The ESL® Spinal 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 ESL® Spinal System may also be implanted using the Accuvision System to amount the surgeon with a minimally invasive approach for posterolateral spinal survery.

Device Description

The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

AI/ML Overview

The provided 510(k) summary for the Biomet Spine ESL® Spinal System does not contain information on a study proving the device meets specific acceptance criteria in the manner typically seen for AI/ML-based devices or studies requiring performance metrics like sensitivity, specificity, or various accuracy measures.

Instead, this submission is focused on demonstrating substantial equivalence to predicate devices for a physical medical implant (intervertebral fusion device). The "study" here refers to the comparisons made to existing devices and mechanical testing, rather than a clinical performance study with specific quantitative acceptance criteria of AI/ML algorithms.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The ESL® Spinal System is a physical medical device designed for spinal applications. Its acceptance for market clearance via a 510(k) submission is based on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting specific performance thresholds derived from a clinical study comparing AI outputs to ground truth.

The "study" that proves the device meets acceptance criteria primarily involves:

Comparison of technological characteristics (material, design, sizing, intended use, indications, principles of operation) to predicate devices.
Mechanical testing to ensure the device's performance is equivalent to, or better than, predicate devices for its intended use, particularly for restoring biomechanical integrity.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate devices)	Reported Device Performance (Summary from text)
Intended Use	Must be similar to predicate devices.	"Substantially equivalent to its predicate devices with respect to intended use and indications."
Indications for Use	Must be similar to predicate devices.	"Substantially equivalent to its predicate devices with respect to intended use and indications."
Technological Characteristics	Material, design, and sizing must be the same as, or similar to, predicate devices.	"The technological characteristics (material, design and sizing) of the ESL® Spinal Spacer is the same as, or similar to, the predicate devices."
Principles of Operation	Must be similar to predicate devices.	"Substantially equivalent to its predicate devices with respect to ... principles of operation."
Safety and Effectiveness	Must not present any new issues of safety or effectiveness compared to predicate devices.	"do not present any new issues of safety or effectiveness."
Biomechanical Integrity	Must be capable of restoring biomechanical integrity. (Implied from indications for use and mechanical testing).	"The ESL Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column..."
Mechanical Performance	Must be substantially equivalent for its intended use to other spacers on the market.	"Based upon the mechanical testing, ESL Spinal System is substantially equivalent for its intended use to other spacers currently on the market."

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission, as it relates to a physical implant and not an AI/ML algorithm requiring a test set of data. The "test set" would primarily refer to the physical devices undergoing mechanical testing, but no numerical sample size for these tests is provided in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable. "Ground truth" in the context of AI/ML refers to objective labels for input data (e.g., expert annotations on images). For a physical medical device like the ESL® Spinal System, there isn't a "ground truth" established by experts in this manner. The evaluation relies on engineering principles, material science, and mechanical testing standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or evaluations of AI/ML algorithms where multiple readers assess the same data and resolve discrepancies.

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

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance for diagnostic tasks. The ESL® Spinal System is a surgical implant, not a diagnostic AI tool.

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

This information is not applicable. The ESL® Spinal System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically defined for AI/ML performance is not applicable here. The "truth" for this device's acceptance is established through:

Compliance with predicate device characteristics: The device's material, design, and indications must align with devices already cleared by the FDA.
Mechanical testing standards: Performance under various load conditions to ensure structural integrity and durability. These are engineering-based "truths" rather than expert consensus on images or pathology results.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical medical device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set, there is no ground truth established for it.

Summary

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

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 outlined in black. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font, also outlined in black. The logo is simple and clean, with a focus on the company name.

510(k) Summary

Preparation Date:	January 28, 2010
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyPhone: 973-299-9300Fax: 973-257-0232	FEB - 4 2010
Trade name:	ESL® Spinal System
Common Name:	Non-cervical spinal spacer
Classification Name:	Intervertebral fusion device, 21 CFR §888.3080Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060
Device Panel/Product Code:	Orthopedic MAX & MQP

Device Description:

The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

Indications for Use:

The ESL® Spinal 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 ESL® Spinal System may also be implanted using the Accu Vision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Summary of Technologies:

The technological characteristics (material, design and sizing) of the ESL® Spinal Spacer is the same as, or similar to, the predicate devices.

Substantial Equivalence:

The ESL 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 effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and the ESL® Spinal System (K061016) has similar design features. Based upon the mechanical testing, ESL Spinal System is substantially equivalent for its intended use to other spacers currently on the market.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vivian Kelly, MS, RAC Regulatory Affairs Project Manager Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054

FEB - 4 2010

Re: K092574

Trade/Device Name: EBI ESL Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: January 28, 2010 Received: January 29, 2010

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. 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

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

Page 2 - Vivian Kelly, MS, RAC

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Barbara Buell

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

Enclosure

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

Indications for Use

510(k) Number (if known): K092574

Device Name: ESL® Spinal System

Indications for Use:

The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal 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 ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal 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.

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)

![signature](data:image/png;base64,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

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

K092574 510(k) Number_

Page 4-2

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.