The CONCORDE Bullet Spinal System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices, these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This 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. When used as a vertebral body replacement device, this system is intended for the use with DePuy Spine supplemental internal fixation products.

Device Description

The CONCORDE Bullet Spinal System is a system of intervertebral body fusion devices consisting of cages and implantation instrumentation. The cages feature a bulleted nose to aid in implant insertion. The proposed cages will offer a titanium alternative at certain geometries to the primary predicate system, which is currently only available in polymer/carbon fiber composite. The cages are available in varying shape and size configurations to match patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The proposed cages will be implanted with the same instrumentation currently used in the system. The proposed cages will be offered sterile or non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the CONCORDE Bullet Spinal System. It seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "study" described herein is not a clinical study to assess patient outcomes or clinical effectiveness in the traditional sense, but rather an engineering and materials performance study to demonstrate the mechanical safety of a new material for an existing device.

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

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

Acceptance Criteria	Reported Device Performance
Mechanical strength per ASTM F-2077 (Dynamic axial compression)	Verified (Mechanical strength of proposed titanium implants)
Axial compressive strength (compared to predicate)	Confirmed (Finite element analysis confirmed strength compared to predicate)

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

Sample size for test set: Not explicitly stated as a "sample size" in the context of a clinical trial. The performance data refers to mechanical testing. The number of physical samples tested for dynamic axial compression and the specific models involved in the finite element analysis are not detailed.
Data provenance: Not applicable in the context of patient data. The tests are engineering tests performed on the device itself.
Retrospective or prospective: Not applicable. These are laboratory-based mechanical tests.

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)

Not applicable. Ground truth in this context refers to engineering standards and specifications (ASTM F-2077) and comparisons to existing predicate device performance. This would be established by engineers and materials scientists, not medical experts like radiologists, as it's a mechanical device performance evaluation, not a diagnostic or treatment outcome evaluation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for clinical assessments. This document describes mechanical testing of a physical device.

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. This is not an AI/software device. It is a physical intervertebral body fusion device.

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

No. This is not an algorithm/software.

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

The "ground truth" for demonstrating the device meets acceptance criteria is based on:

Engineering Standards: Conformance to ASTM F136 for Ti-6A1-4V-Eli titanium alloy and mechanical testing per ASTM F-2077.
Comparison to Predicate Devices: Demonstrating that the mechanical performance (dynamic axial compression, axial compressive strength) of the new titanium cages is equivalent to or better than the performance of the previously cleared polymer/carbon fiber composite predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of the Study:

The "study" described is a materials and mechanical performance evaluation designed to demonstrate that a new material (titanium alloy) proposed for the CONCORDE Bullet Spinal System cages is substantially equivalent to the previously cleared polymer/carbon fiber composite material used in the predicate devices.

Acceptance Criteria: Mechanical strength as characterized by dynamic axial compression testing per ASTM F-2077 and axial compressive strength confirmed by finite element analysis, with the benchmark being equivalence or superiority to the predicate device's performance.
Methodology:
- Dynamic axial compression testing: Physical samples of the proposed titanium implants were subjected to dynamic axial compression testing according to ASTM F-2077. The results "verified the mechanical strength."
- Finite Element Analysis (FEA): FEA was used to confirm the axial compressive strength of the titanium material in comparison to the predicate's material.
Justification for Limited Testing: The document explicitly states that "No other testing was required because the only modification that would affect performance compared to predicate and reference devices... is the material, which is used for the same indications in the predicate DEVEX System (K023835)." This indicates that since the design and intended use are similar, and the new material itself has been used in other cleared devices for similar applications, extensive re-testing beyond mechanical integrity was deemed unnecessary for substantial equivalence.

This is a typical approach for demonstrating substantial equivalence for minor material changes in a physical medical device under a 510(k) pathway, focusing on engineering safety and performance rather than clinical efficacy.

Summary

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

October 8, 2015

MEDOS International Sárl c/o Mr. Jeffrey Shiffman Senior Regulatory Affairs Specialist DePuy Spine, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767

Re: K151352

Trade/Device Name: CONCORDE Bullet Spinal System Regulation Number: 21 CFR 800.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 9, 2015 Received: September 10, 2015

Dear Mr. Shiffman:

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K151352

Device Name CONCORDE Bullet Spinal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

A.	Submitter Information
	Manufacturer:	Medos International SárlChemin-Blanc 382400 Le Locle, Switzerland
	Submitter:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
	Contact Person:	Jeffrey Shiffman325 Paramount DriveRaynham, MA 02767
	Telephone number:	508-977-3857
	Fax number:Email:	908-828-3797jshiffma@its.jnj.com
B.	Date Prepared	May 8, 2015
C.	Device Name
		Trade/Proprietary Name:	CONCORDE Bullet Spinal System
	Common/Usual Name:	Intervertebral Body Fusion DeviceVertebral Body Replacement Device
	Classification Name (Code):	Intervertebral body fusion deviceper 21 CFR § 888.3080 (MAX)Spinal intervertebral body fixation orthosisper 21 CFR § 888.3060 (MQP)

D. Predicate Device Name

Trade name: Bengal System, Bengal Stackable System, Devex System, Ocelot Stackable Cage System, Concorde (Bullet and Inline) Lumbar Interbody System, Cougar System, Cougar LS Lateral Cage System, Leopard System (K140759) – Primary predicate

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DePuy Spine BENGAL, CONCORDE, COUGAR, DEVEX, and LEOPARD Systems (K081917) - Additional predicate DEVEX Mesh System (K023835) - Additional predicate

Device Description E.

F. Intended Use

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G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The proposed additions to the CONCORDE Bullet Spinal System are equivalent to the predicate and reference devices within the system (reference K140759 and K081917), except for a change in the material. Currently, the CONCORDE Bullet Spinal System cages are available in polymer/carbon fiber composite. The proposed cages will be available in titanium alloy, the same material as used in the DEVEX System (K023835).

H. Materials

The proposed additions to the CONCORDE Bullet Spinal System cages will be manufactured from Ti-6A1-4V-Eli titanium alloy and conforms to the standard specifications for surgical implant applications defined in ASTM F136.

I. Performance Data

A summary of performance data per ASTM F-2077 is included to characterize the subject CONCORDE Bullet Spinal System cages addressed in this notification. Dynamic axial compression testing verified the mechanical strength of the proposed titanium implants. A finite element analysis also confirmed the axial compressive strength of the material compared to the predicate. No other testing was required because the only modification that would affect performance compared to predicate and reference devices within the CONCORDE Bullet Spinal System (K140759, K081917) is the material, which is used for the same indications in the predicate DEVEX System (K023835).

J. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the proposed device is substantially equivalent to the predicate devices. Based on the 510(k) flowchart and the review of performance data, the proposed titanium cages in the CONCORDE Bullet Spinal System are substantially equivalent to the predicate devices. The technological characteristics between the proposed device and its predicates are substantially equivalent and the performance data raises no new questions of safety or effectiveness. Additionally, the proposed device does not constitute a new intended use.

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.