The PLYMOUTH™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

Device Description

The PLYMOUTH™ Thoracolumbar Plate System consists of rigid plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). These implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.

AI/ML Overview

This document is a 510(k) summary for the PLYMOUTH™ Thoracolumbar Plate System. It describes the device, its indications for use, and the performance data submitted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that mechanical testing was conducted "in accordance with 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 to demonstrate substantial equivalence to the predicate system." It lists the types of tests: "static and dynamic compression bending and static torsion."

While the document indicates what tests were performed and which guidance document they followed, it does not explicitly state specific numerical acceptance criteria (e.g., minimum strength, maximum deformation) or the quantitative results of these tests for either the new device or the predicate. It only broadly asserts that the device is "similar to the predicate devices with respect to technical characteristics, design, materials, performance, and intended use" and that the information "supports substantial equivalence."

Therefore, a table with specific numbers for acceptance criteria and reported performance cannot be fully constructed from the provided text.

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

The document describes mechanical testing of the device itself, not clinical testing on human subjects. Therefore, the concepts of "test set" and "data provenance" (country of origin, retrospective/prospective) as they relate to human patient data are not applicable here. The "test set" refers to the physical devices tested in the lab. The sample size for these mechanical tests is not explicitly stated in the provided text.

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

This question is not applicable. Ground truth, in the context of expert consensus, typically refers to clinical data interpreted by medical professionals. This document focuses on mechanical performance of a medical device in a laboratory setting, not diagnostic or clinical accuracy determined by experts.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 refer to consensus processes among human reviewers of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers evaluating medical cases (e.g., medical images) to compare the effectiveness of different diagnostic or interventional approaches, often with and without AI assistance. This 510(k) pertains to the mechanical performance of a spinal implant, not a diagnostic or AI-assisted interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. This 510(k) is for a physical medical device (thoracolumbar plate system), not for an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is established by engineering standards and predicate device performance. The mechanical tests (static and dynamic compression bending, static torsion) are designed to assess physical properties and durability against established industry guidance for spinal systems. The "truth" is whether the device meets these mechanical performance expectations and performs "similar" to legally marketed predicate devices.

8. The Sample Size for the Training Set:

This question is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) is for a physical medical device and does not involve an AI or machine learning component.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reasons as point 8.

In summary, the provided document details the mechanical testing of a spinal implant for 510(k) clearance, asserting substantial equivalence to predicate devices based on adherence to FDA guidance. It does not involve clinical studies with human subjects, expert consensus, or artificial intelligence/machine learning components that would necessitate the information requested in many of your questions.

Summary

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APR 1 3 2012

20097

510(k) Summary: PLYMOUTH™ Thoracolumbar Plate System

Company:	Globus Medical Inc.Valley Forge Business Center2560 General Armistead AvenueAudubon, PA 19403(610) 930-1800
Contact:	Sarah Marie FitzgeraldProject Manager, Regulatory Affairs
Date Prepared:	January 10, 2012
Device Name:	PLYMOUTH™ Thoracolumbar Plate System
Classification:	Per 21 CFR as follows:§888.3060: Spinal Intervertebral Body Fixation OrthosisProduct Code: KWQ.Regulatory Class: II, Panel Code: 87.
Predicate(s):	TRUSS® Thoracolumbar Plate System (K092108)SE date: August 13, 2009Nuvasive Lateral Plate System (K091071)

Purpose:

The purpose of this submission is to request clearance for the PLYMOUTH™ Thoracolumbar Plate System.

Device Description:

Indications for Use:

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120097

Performance Data:

Mechanical testing (static and dynamic compression bending and static torsion) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 to demonstrate substantial equivalence to the predicate system.

Basis of Substantial Equivalence:

The PLYMOUTH™ Thoracolumbar Plate System is similar to the predicate devices with respect to technical characteristics, design, materials, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

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

Globus Medical Incorporated % Ms. Sarah Marie Fitzgerald Project Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K120092

Trade/Device Name: PLYMOUTH™ Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 19, 2012 Received: March 20, 2012

Dear Ms. Fitzgerald:

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

APR 1 3 2012

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Page 2 - Ms. April Lee

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 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.

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,
Eunel Keith

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

Enclosure

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Indications for Use Statement

510(k) Number:

K120092

Device Name:

PLYMOUTH™ Thoracolumbar Plate System

Indications:

OR Over-The-Counter Use Prescription Use × (Per 21 CFR §801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical Orthopedic, and Restorative Devices

K120092 510(k) Number

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.