The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.

Device Description

The DePuy Pulse Cervical Cage System is designed for use as a cervical intervertebral body fusion device. The implant devices are available in various geometries and sizes to accommodate patient anatomy. The implant devices are manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and also contain tantalum wires per ASTM F-560. The DePuy Pulse Cervical Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

The provided text describes a medical device, the DePuy Pulse Cervical Cage System, and its 510(k) summary for FDA clearance. However, the document does NOT contain information about acceptance criteria or a study proving the device's performance based on such criteria in a clinical setting with human subjects.

The "Non-clinical Test Summary" section mentions mechanical tests that were conducted and that "The acceptance criteria was/were met." This refers to engineering and mechanical performance (e.g., strength, durability) of the implant itself, not patient outcomes or clinical effectiveness thresholds.

Therefore, many of the requested details cannot be extracted from the provided text because they pertain to clinical performance studies, which were explicitly stated as not performed.

Here's a breakdown of what can and cannot be answered based on the provided input:

Acceptance Criteria and Device Performance Study Details for the DePuy Pulse Cervical Cage System

The provided 510(k) summary for the DePuy Pulse Cervical Cage System (K120517) details non-clinical mechanical testing to establish substantial equivalence to predicate devices. It explicitly states, "No clinical tests were performed." Therefore, information regarding clinical performance acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance in a clinical context cannot be provided.

The acceptance criteria mentioned in the document relate to the mechanical properties of the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Static and Dynamic Compression (ASTM F-2077)	Met standard requirements for intervertebral body fusion devices.	Acceptance criteria was/were met.
Static and Dynamic Torsion (ASTM F-2077)	Met standard requirements for intervertebral body fusion devices.	Acceptance criteria was/were met.
Static and Dynamic Compression Shear (ASTM F-2077)	Met standard requirements for intervertebral body fusion devices.	Acceptance criteria was/were met.
Subsidence (ASTM F-2267)	Met standard requirements for measuring load-induced subsidence of intervertebral body fusion devices under static axial compression.	Acceptance criteria was/were met.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable for clinical performance as "No clinical tests were performed." For non-clinical mechanical testing, specific sample sizes are not detailed in the summary, but such tests typically use a defined number of device units.
Data Provenance: Not applicable for clinical performance. The mechanical testing data would originate from the manufacturer's laboratory or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical tests were performed to establish ground truth for patient outcomes.

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

Not applicable, as no clinical tests were performed requiring adjudication of results in a clinical context.

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

Not applicable. This device is an intervertebral body fusion device (an implant), not an AI/imaging diagnostic tool. No clinical studies, let alone MRMC studies, were performed.

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

Not applicable. This device is an intervertebral body fusion device (an implant), not an AI/software algorithm.

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

Not applicable for clinical performance. For the mechanical tests, the "ground truth" is defined by the specified ASTM standards and their associated pass/fail criteria (e.g., maximum load before failure, deformation limits).

8. The sample size for the training set

Not applicable, as "No clinical tests were performed" and no machine learning algorithm is involved.

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

Not applicable.

Summary

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KI20217

APR 2 6 2012

510(K) SUMMARY

Submitter:	Medos International SàrlChemin-Blanc 38Le Locle, CH-NE 2400, Switzerland
Contact Person:	Eugene BangRegulatory Affairs AssociateDePuy Spine, Inc.Voice: (508) 977-3966Fax: (508) 828-3797
Date Prepared:	February 17, 2012
Trade Name:	DePuy Pulse Cervical Cage System
Device Class:	Class II
Product Code(s):	ODP
Common Name:	Intervertebral Fusion Device with Bone Graft, Cervical
Classification Name:	Intervertebral Body Fusion Device
Regulation Number:	888.3080
Predicate Devices:	Bengal System - K081917, K103488Concorde System - K081917Lumbar I/F Cage System - P960025'LDR Spine Cervical Interbody Fusion System - K091088
Device Description:	The DePuy Pulse Cervical Cage System is designed for use as a cervicalintervertebral body fusion device. The implant devices are available invarious geometries and sizes to accommodate patient anatomy. Theimplant devices are manufactured from medical gradepolyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 andalso contain tantalum wires per ASTM F-560.The DePuy Pulse Cervical Cage System also contains Class 1 manualsurgical instruments and cases that are considered exempt frompremarket notification.
Indications:	The DePuy Pulse Cervical Cage System is indicated for use as an intervertebralbody fusion device in skeletally mature patients with degenerative disc disease(defined as discogenic neck pain with degeneration of the disc confirmed bypatient history and radiographic studies) at one level of the cervical spine withaccompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage Systemimplants are used to facilitate fusion in the cervical spine (C2 - T1) and areplaced via an anterior approach using autogenous bone. DePuy Pulse CervicalCage System implants are intended to be used with supplemental internal fixationsystem.
Materials:	Manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LTI)per ASTMF F-2026 and tantalum wires per ASTM F-560.
Comparison toPredicate Device:	The substantial equivalence of the subject device to the predicates indentifiedabove is based upon the equivalence of intended use, design (fundamentalscientific technology), materials, manufacturing methods, performance, sterility,biocompatibility, safety and packaging design.
Non-clinical TestSummary:	The following mechanical tests were conducted:Static and dynamic compression testing in accordance with ASTM F-2077Standard Test Method for Intervertebral Body Fusion Devices. Theacceptance criteria was/were met. Static and dynamic torsion testing in accordance with ASTM F-2077Standard Test Method for Intervertebral Body Fusion Devices. Theacceptance criteria was/were met. Static and dynamic compression shear testing in accordance with ASTM F-2077 Standard Test Method for Intervertebral Body Fusion Devices. Theacceptance criteria was/were met. Subsidence testing in accordance with ASTM F-2267 Standard Test Methodfor Measuring Load Induced Subsidence of Intervertebral Body FusionDevice Under Static Axial Compression. The acceptance criteria was/weremet.
Clinical TestSummary:	No clinical tests were performed.
Conclusion:	Based on the predicate comparison and testing, the subject device DePuy PulseCervical Cage System is substantially equivalent to the predicate devices.

1 This device was re-classified from a Class III (PMA) device to a Class II (510K) device via petition approved on 2007

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队120517

Pg 2 of 2

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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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

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

Medos International Sarl % Mr. Eugene Bang DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

APR 2 6 2012

Re: K120517

Trade/Device Name: DePuy Pulse Cervical Cage System Regulation Number: 21 CFR 8880.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 17, 2012 Received: February 21, 2012

Dear Mr. Bang:

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

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Page 2 - Mr. Eugene Bang

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,
Mark A. Millman

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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12051

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120517

Device Name: DePuy Pulse Cervical Cage System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

Division Sign Off

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

510(k) Number K120517

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.