The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Device Description

The CONCORDE LIFT Expandable Interbody Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6Al-4V) as per ASTM F136. A cavity internal to each device is intended to hold autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CONCORDE LIFT is available in both a convex configuration and a lordotic configuration.

The purpose of this submission is to add MR Conditional labeling, expanded indications and to document minor design modifications.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the CONCORDE LIFT™ Intervertebral Body Fusion Device. This type of submission to the FDA focuses on establishing substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials.

As such, the document does not contain the detailed information typically associated with establishing acceptance criteria and proving performance through a comprehensive study, especially for an AI/ML powered device. The "performance data" section (I) refers to various ASTM standards related to MR compatibility (magnetically induced displacement force, image artifacts, radiofrequency induced heating, magnetically induced torque) and an ANSI/AAMI standard for bacterial endotoxins. These are engineering and biocompatibility tests, not clinical performance or AI algorithm validation studies.

Therefore, I cannot provide answers to most of your specific questions as they pertain to the evaluation of an AI/ML-powered medical device through a clinical performance study. The document describes a traditional medical device submission, primarily relying on mechanical and material testing, and comparison to predicate devices, rather than an AI algorithm.

However, I can extract what is available from the document regarding the device and its assessment:

Device Name: CONCORDE LIFT™
Device Type: Intervertebral Body Fusion Device (a mechanical implant, not an AI/ML algorithm)
Regulatory Class: Class II (Product Code: MAX)
Purpose of Submission: To add MR Conditional labeling, expanded indications, and to document minor design modifications.

Here's what can be inferred or confirmed from the provided text, while acknowledging that the core request for "AI acceptance criteria and study" is not applicable to this specific document:

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

The document lists standards rather than specific quantitative acceptance criteria or reported values in a table format for each test. The implicit "acceptance criterion" for these tests is "conformance to the standard" to demonstrate safety and MR compatibility.

Acceptance Criterion (Standard)	Reported Performance (Implied)
ASTM F2052-15 (Measurement of Magnetically Induced Displacement Force)	Device was tested in accordance with this standard.
ASTM F2119-07 (Evaluation of MR Image Artifacts)	Device was tested in accordance with this standard.
ASTM F2182-11a (Measurement of Radio Frequency Induced Heating)	Device was tested in accordance with this standard.
ASTM F2213-06 (Measurement of Magnetically Induced Torque)	Device was tested in accordance with this standard.
ANSI/AAMI ST72 (Bacterial endotoxins - Test methods, routine monitoring)	Device was tested in accordance with this standard.

2. Sample sized used for the test set and the data provenance:

This information is not provided in the document. The tests mentioned (ASTM standards) are typically performed on samples of the device itself, not on patient data.
Data provenance for a physical device would refer to its manufacturing process and quality control, not clinical data provenance.

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

Not Applicable. This is a physical intervertebral fusion device, not an AI/ML algorithm requiring expert-established ground truth from images or clinical data.

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

Not Applicable. No human adjudication of diagnostic or clinical performance is mentioned or relevant for this type of device submission.

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 not an AI/ML assistant for readers; it's a surgical implant.

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

Not Applicable. This is not an algorithm.

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

Not Applicable for clinical ground truth. The "ground truth" for the device's physical and material properties would be established by the specifications defined in the ASTM standards (e.g., maximum allowable displacement force, temperature rise, etc.) and validated through specific laboratory testing methodologies.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

In summary: The provided document is a 510(k) submission for a traditional implantable medical device, the CONCORDE LIFT™ Intervertebral Body Fusion Device. The "acceptance criteria" and "study" described are focused on engineering and material performance (primarily MR compatibility) according to established industry standards, not on the clinical performance or validation of an AI/ML algorithm. Therefore, the questions related to AI/ML device validation are not applicable to the content of this specific FDA submission.

Summary

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

July 20, 2017

Medos International, SARL % Ms. Desiree Saracino Regulatory Affairs Specialist DePuv Synthes 325 Paramount Drive Raynham, Massachusetts 02767

Re: K171425

Trade/Device Name: CONCORDE LIFT™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 27, 2017 Received: June 30, 2017

Dear Ms. Saracino:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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) K171425

Device Name CONCORDE LIFT™

Indications for Use (Describe)

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information A.

510(k) Sponsor:	Medos International, SARL
Contact Person:	Desiree SaracinoDePuy Synthes325 Paramount DriveRaynham, MA 02767
Telephone number:	(508) 977-3842
Fax number:	(508) 828-3797
Email:	Dsaracin@its.jnj.com
Date Prepared	July 18, 2017
Device Name
Trade/Proprietary Name:	CONCORDE LIFT™
Common/Usual Name:	Intervertebral Body Fusion Device
Device Classificationand Regulation:	Class II per 21 CFR § 888.3080
Classification Product and PanelCode:	MAX; Orthopedic
Predicate Device Name
Primary:	K160464: Opticage™ Expandable Interbody Fusion Device

K152156: Opticage™ Expandable Interbody Fusion Device Additional: K113527: Opticage™ Expandable Interbody Fusion Device K162879: Elite™ Expandable Interbody Fusion Device (Spineology Inc.)

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E. Device Description

The purpose of this submission is to add MR Conditional labeling, expanded indications and to document minor design modifications.

F. Indications for Use

The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

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

The technological characteristics, including material, design and performance of the CONCORDE LIFT Expandable Interbody Fusion Device are consistent with those of the predicate devices.

H. Materials

The CONCORDE LIFT Expandable Interbody Device is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136.

I. Performance Data

The CONCORDE LIFT Expandable Interbody Device was tested in accordance with the standards listed below.

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ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging

ASTM F2213-06 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ANSI/AAMI ST72 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

J. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the CONCORDE LIFT Expandable Interbody Device is substantially equivalent to the legally marketed predicate devices.

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.