The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

Device Description

The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices:

Caro™ Cervical Cage System
Halis™ Lumbar Cage System
Lydia™ Anterior Lumbar Fusion System
. Dica™ Direction Changeable Lumbar Cage System

All components are made of polyetheretherketone (PEEK). All fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical or lumbar spine. These Fusion Devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during intervertebral body fusion surgeries. All components have serrations on the superior and inferior surfaces of the implant to aid in fixation. The hollow geometry of the implants allows them to be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Radiopaque Markers manufactured from unalloyed tantalum have been embedded within the implant to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of device.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for the Shanghai Sanyou PEEK Cage System. This document focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study or AI performance evaluation.

Therefore, the information you've requested regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not typically found in this type of regulatory submission for a PEEK cage system.

A 510(k) submission for an intervertebral body fusion device primarily relies on non-clinical performance testing to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

Here's what can be extracted and what cannot be from the provided text:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical endpoints, but rather compliance with recognized standards. The acceptance criteria essentially boil down to meeting or exceeding the performance of predicate devices in mechanical testing and adherence to relevant ASTM standards.
Reported Device Performance:
- Mechanical Testing: Static and dynamic axial compression, static shear compression, static torsion.
- Subsidence Testing: Completed according to ASTM F2267-04.
- Overall Conclusion: "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."

This is how the performance is generally reported in this context, focusing on equivalence rather than specific performance metrics against a defined standard (e.g., 90% accuracy, 0.9 AUC).

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

Not Applicable. This document describes mechanical performance testing of the device itself, not clinical testing on human subjects with a test set of data. The "test set" would be the physical devices subjected to the mechanical tests.
Data Provenance: Not applicable for a clinical study, but the manufacturing facilities are in Shanghai, China.

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. No human experts were used for adjudication of a ground truth for a clinical dataset. The "ground truth" here is established by the relevant ASTM standards for mechanical properties.

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

Not Applicable. There's no adjudication method described as it refers to mechanical testing by standard protocols, not expert consensus on clinical data.

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 a physical medical device (PEEK cage), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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 consensus, pathology, outcomes data, etc):

For the performance testing, the "ground truth" is defined by the ASTM standards (ASTM F2077-14 for mechanical tests and ASTM F2267-04 for subsidence testing) and the established performance characteristics of the legally marketed predicate devices. The device is considered to meet acceptance criteria if its mechanical properties meet or exceed those of the predicates and comply with the specified ASTM standards.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design and manufacturing implicitly comes from engineering principles, material science, and the design history of similar predicate devices.

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

Not Applicable. As there's no training set in the context of AI, there's no ground truth establishment for it. The standards and predicate device characteristics guide the design and testing process, but not in the sense of a "training set" ground truth.

In summary, the provided document is a regulatory submission for a physical implantable device (intervertebral body fusion cage), not an AI/software as a medical device. The "acceptance criteria" and "study" are described in terms of compliance with regulatory standards and mechanical performance testing demonstrating substantial equivalence to predicate devices, rather than clinical efficacy studies on patient data or AI algorithm performance tests.

Summary

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

September 18, 2017

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

Re: K163422

Trade/Device Name: Shanghai Sanyou PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: August 25, 2017 Received: August 30, 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,

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) K163422

Device Name Shanghai Sanyou PEEK Cage System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Shanghai Sanyou PEEK Cage System September 8, 2017

Company:	Manufacturing Facility and Headquarters:Shanghai Sanyou Medical Co, LTD1988 Jiatang RoadJiading District, Shanghai, 201807, China
	Manufacturing Facility:Shanghai Sanyou Medical Co, LTDRm 101/102/106/107356 Renqing Rd, Building 3-1F,Pudong New District, Shanghai 201201, China
Primary Contact:	Christine ScifertPhone: 901-831-8053christine.scifert@mrc-x.com
Company Contact:	David Fan, VP, MarketingPhone: +86 21 58389980Fax: +86 21 38682915david.fan@sanyou-medical.com
Trade Name:	Shanghai Sanyou PEEK Cage System
Common Name:	Intervertebral Body Fusion Device with Bone Graft, CervicalIntervertebral Body Fusion Device with Bone Graft, Lumbar
Classification:	Class II
Regulation Number:	21 CFR 888.3080 (Intervertebral Body Fusion Device)
Panel:	87- Orthopedic
Product Code:	ODP, MAX
PrimaryPredicate Device:	K132897 – Medtronic Clydesdale® Spinal System
Additional PredicateDevices:	K072791 - Depuy Synthes Spine, OPAL SpacerK094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal SystemK151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal SystemK153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cervical FusionSystem

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Device Description:

The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices:

Caro™ Cervical Cage System
Halis™ Lumbar Cage System
Lydia™ Anterior Lumbar Fusion System
. Dica™ Direction Changeable Lumbar Cage System

Several additional predicates and reference devices are identified and are used to support the substantial equivalence of the individual components of the Shanghai Sanyou PEEK Cage System as described in Table 1 below.

Predicate Devices
Predicate Device	PredicateUsage	Subject Device Supported	Rationale for Support
K132897, ClydesdaleSpinal System	Lumbar	Halis™ Lumbar Cage System	Equivalent size range, anatomicusage, and implantation approach
K072791, OPAL Spacer	Lumbar	Halis™ Lumbar Cage System	Equivalent size range, anatomicusage, and implantation approach
K094025, CrescentSpinal System	Lumbar	Dica™ Direction ChangeableLumbar Cage System	Equivalent size range, anatomicusage, and implantation approach
K151128, CapstoneSpinal System	Lumbar	Halis™ Lumbar Cage System	Equivalent size range, anatomicusage, and implantation approach
K153373, CornerstoneSpinal System	Cervical	Caro™ Cervical Cage System	Equivalent size range, anatomicusage, and implantation approach
Reference Devices
Reference Device	ReferenceUsage	Subject Device Supported	Rationale for Support
K150765, ROI-C FusionSystem	Cervical	Caro™ Cervical Cage System	Equivalent size range, anatomicusage, and implantation approach
K121982, SovereignSpinal System	Lumbar	Lydia™ Anterior LumbarFusion System	Equivalent size range, anatomicusage, and implantation approach

Table 1. Predicate and Reference Devices

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Indications for Use:

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

Performance Testing:

Static and dynamic axial compression, static shear compression, static torsion and were completed for the Shanghai Sanyou PEEK Cage System according the ASTM F2077-14 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004. Additionally, subsidence testing was completed according to ASTM F2267-04. 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.

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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 subject devices are substantially equivalent to the predicate devices.

K132897 – Medtronic Clydesdale® Spinal System

K072791 – Depuy Synthes Spine, OPAL Spacer

K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System

K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal System

K153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cervical Fusion System

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.