The Carmen plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.

Carmen anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyste formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The Carmen™ cage must be used with supplemental fixation. The Carmen™ cage is also required to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the Carmen components can be used only to treat cervical disc disease.

Device Description

Shanghai Sanyou Carmen™ Cervical Fusion System includes cervical plates and screws and interbody cages to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The interbody device is available in 2 widths (12 mm and 14 mm) and 4 heights (4, 5, 6 and 7 mm) and is composed of PEEK. The interbody device is offered with only one lordosis angle; each size is available with 7° lordosis. The plate is available in small or large with an integrated locking screw. The self-tapping screw is available in 3.5 or 4.0 mm diameter screws either 13 mm, 15 mm or 17 mm in length.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Shanghai Sanyou CARMEN Cervical Fusion System. It primarily focuses on the regulatory clearance process and equivalency to predicate devices, rather than detailed acceptance criteria and a study proving device performance in a statistical sense for an AI/algorithm.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as they pertain to studies typically performed for AI/algorithmic devices, which is not the nature of this submission. The "Performance Testing" section describes mechanical testing for a spinal implant, not an AI model.

Here's an analysis based on the provided text, focusing on what can be extracted:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the CARMEN Cervical Fusion System performs as intended and is substantially equivalent to legally marketed predicate devices. The study proving this comes in the form of performance testing as required for spinal implants.

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

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance (PEEK Cage System)	Meets or exceeds performance of predicate devices according to:
* Axial Compression Bending (Static & Dynamic)	ASTM F2077-14 (Standard Test Methods for Intervertebral Body Fusion Devices)
* Shear Compression Bending (Static)	Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004
* Subsidence Testing
Mechanical Performance (Plate Dynamic Compression Testing)	Meets or exceeds performance of predicate devices according to:
* Dynamic Compression	ASTM F1717-15 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
Substantial Equivalence to Predicate Devices	The device is deemed substantially equivalent to predicate devices (Medtronic Sofamor Danek, DIVERGENCE™ Anterior Cervical Fusion System; Medtronic Sofamor Danek CORNERSTONE® PSR Spinal System; Shanghai Sanyou, Katia Cervical Plate) based on: - Similar sizes, materials, and geometry of system components. - Same indications for use. - Mechanical testing results.

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

This information is not provided in the document. For mechanical testing of physical devices, "sample size" would refer to the number of devices tested, and "data provenance" might relate to where the testing occurred, but these details are not present.

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)

This is not applicable as this document describes a physical medical device (spinal fusion system) and its mechanical testing, not an AI/algorithmic device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable for a physical medical device's mechanical testing.

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 is for a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical performance testing, the "ground truth" would be the engineering specifications and performance standards established by organizations like ASTM, determined by the mechanical properties and failure points observed in testing. For substantial equivalence, the predicates' established safety and effectiveness are the reference.

8. The sample size for the training set

Not applicable. This is about mechanical testing of a physical device, not an AI/algorithm with a training set.

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

Not applicable. There is no training set for a physical device in this context.

Summary

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

October 5, 2017

Shanghai Sanyou Medical Co, Ltd % Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119

Re: K163366

Trade/Device Name: Shanghai Sanyou CARMEN Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, KWQ Dated: September 5, 2017 Received: September 6, 2017

Dear Ms. Scifert:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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,

Katherine D. Kavlock -S

for 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) K163366

Device Name

Shanghai Sanyou CARMEN Cervical Fusion System

Indications for Use (Describe)

When used together, the Carmen components can be used only to treat cervical disc disease.

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

Shanghai Sanyou CARMEN Cervical Fusion System September 22, 2017

Company:	Manufacturing Facility and Headquarters:
	Shanghai Sanyou Medical Co, LTD
	1988 Jiatang Road
	Jiading District, Shanghai, 201807, China
	Manufacturing Facility:
	Shanghai Sanyou Medical Co, LTD
	Rm 101/102/106/107
	356 Renqing Rd, Building 3-1F,
	Pudong New District, Shanghai 201201, China
Primary Contact:	Christine Scifert
	Phone: 901-831-8053
	christine.scifert@mrc-x.com
Company Contact:	David Fan, VP, Marketing
	Phone: +86 21 58389980
	Fax: +86 21 38682915
	david.fan@sanyou-medical.com
Trade Name:	Shanghai Sanyou CARMEN Cervical Fusion System
Common Name:Device	Spinal Intervertebral Body Fixation Orthosis, Intervertebal Body Fusion
Classification:	Class II
Regulation Number:	21 CFR 888.3060 (Spinal Intervertebral Body Fixation Orthosis)21 CFR 888.3080 (Intervertebal Body Fusion Device)
Panel:	87- Orthopedic
Product Code:	KWQ, ODP

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Primary Predicate

Device:

K142450 – Medtronic Sofamor Danek, DIVERGENCE™ Anterior Cervical Fusion System

Additional Predicate

Devices:	K100214 – Medtronic Sofamor Danek CORNERSTONE® PSR Spinal System
	K131512 – Shanghai Sanyou, Katia Cervical Plate

Device Description:

Indications for Use:

The Carmen™ plate and bone screw components are intended for anterior interbody screw fixation from C2-Tl. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.

Carmen™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The Carmen™ cage must be used with supplemental fixation. The Carmen™ cage is also required to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the Carmen™ components can be used only to treat cervical disc disease.

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Performance Testing:

Static and dynamic axial compression bending, static shear compression bending and subsidence testing were completed for the Shanghai Sanyou PEEK Cage System according the ASTM F2077-14, ASTM F2067-04, and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004. Plate dynamic compression testing was conduct according to ASTM F1717-15. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.

Comparison of Technology:

The subject and primary predicate device (DIVERGENCE Anterior Cervical Fusion System) include a titanium alloy cervical plate component that mates with a PEEK interbody device. Additionally, the indications for use is the same for the subject device as the predicate device. The primary difference between the subject and predicate devices is the size range of plates and locking screws. The subject plate components range include a 16.5 mm and 18.5 mm plate with 13, 14 and 17 mm length locking screws. The predicate plate components have a larger range of sizes included 15.5-20.5 mm plates and 9-17 mm locking screws. Additionally, there are geometry differences between the subject and predicate devices. Mechanical testing demonstrates that the subject device is substantially equivalent to the predicate devices.

Substantial Equivalence:

The subject systems components are similar in sizes, materials and geometry to the predicate components. The subject components have the same indications as the predicate components. The difference in the subject and predicate devices do not rendered the system not substantially equivalent.

(Primary Predicate) K142450 – Medtronic Sofamor Danek, DIVERGENCE™ Anterior Cervical Fusion System

K100214 – Medtronic Sofamor Danek CORNERSTONE® PSR Spinal System

K131512 - Shanghai Sanyou, Katia Cervical Plate

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.