The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

Device Description

The Adena-Zina System consists of a variety of a variety of shapes and sizes of screws and 5.5 and 6.35 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, fixed angle reduction screws, multi-axial and multiaxial reduction screws, T-links, domino connectors, and sacro-illiac connectors.

AI/ML Overview

This document describes a 510(k) premarket notification for the Adena-Zina System, a pedicle screw spinal system. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting a novel clinical study with acceptance criteria in the way a new drug or a more complex diagnostic device might.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically regarding device performance and human interpretation, is not applicable in the context of this 510(k) summary for a pedicle screw spinal system. This document primarily describes mechanical performance testing against established standards.

However, I can extract and present the information that is available concerning performance testing and the comparison to a predicate device.

Summary of Device Performance Testing (Not Acceptance Criteria in the context of a clinical study for AI/diagnostic devices):

The Adena-Zina System underwent mechanical performance testing to demonstrate its substantial equivalence to a predicate device.

Test Type	Standard	Reported Device Performance
Static Compression Bending	ASTM F1717-12	Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System)
Static Torsion	ASTM F1717-12	Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System)
Fatigue Compression Bending	ASTM F1717-12	Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System)
Axial Grip Testing	ASTM F1798-13 (for connectors)	Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System)

Regarding the specific questions posed:

A table of acceptance criteria and the reported device performance:
- As shown in the table above, the "acceptance criteria" here are defined by meeting or exceeding the performance of the predicate device for specified mechanical tests according to ASTM standards. There are no specific quantitative acceptance criteria listed in this summary, but rather a comparative statement.
Sample size 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. The testing described is mechanical bench testing of components, not clinical data from patients. The manufacturer is Shanghai Sanyou Medical Company, Limited (China).
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. This is mechanical testing against engineering standards, not expert-based clinical ground truth assessment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical bench testing.
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 medical device (implantable system) for spinal fixation, not an AI software or diagnostic imaging device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this type of submission is adherence to recognized industry standards (ASTM F1717-12, ASTM F1798-13) and comparable performance to a legally marketed predicate device (Medtronic CD Horizon Spinal System, K123809).
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence for this type of device.
How the ground truth for the training set was established:
- Not applicable.

In conclusion: The provided document is a 510(k) summary for an orthopedic implant. The "performance testing" described refers to mechanical bench testing conducted to demonstrate that the device is substantially equivalent to a predicate device in terms of engineering characteristics. It does not involve clinical studies, human readers, or AI algorithms typically associated with the "acceptance criteria" and "study" questions posed.

Summary

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

Shanghai Sanyou Medical Company, Limited % Kimberly Strohkirch, MSE Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K152781

Trade/Device Name: Adena-Zina System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: January 25, 2016 Received: January 27, 2016

Dear Ms. Strohkirch:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

February 12, 2016

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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/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 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) K152781

Device Name Adena-Zina System

Indications for Use (Describe)

The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Adena-Zina System January 25, 2016

Company:	Manufacturing Facility and Headquarters:Shanghai Sanyou Medical Co, LTD1988 Jiatang RoadJiading District, Shanghai, 201807, ChinaManufacturing Facility:Shanghai Sanyou Medical Co, LTDRm 101/102/106/107356 Renqing Rd, Building 3-1F,Pudong New District, Shanghai 201201, China
Primary Contact:	Kimberly StrohkirchPhone: 901-361-2037Fax: 901-318-5380strohkirch@memphisregulatory.com
Company Contact:	David Fan, VP, MarketingPhone: +86 21 58389980Fax: +86 21 38682915david.fan@sanyou-medical.com
Trade Name:	Adena-Zina System
Common Name:	Pedicle Screw Spinal System
Classification:	Class III
Regulation Number:	21 CFR 888.3070 (Orthosis, Spondylolisthesis Spinal Fixation; Orthosis,Spinal Pedicle Fixation)
Panel:	87- Orthopedic
Product Code:	NKB, MNH, MNI
Predicate Devices:	K123809 – Medtronic CD Horizon Spinal System(primary predicate device)

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Additional predicate devices: K013962 – Medtronic EQUATION™ Fixation System K122332 – Captiva Spine TowerLOX Pedicle Screw System

Device Description:

Indications for Use:

Performance Testing:

Static compression bending, static torsion, and fatigue compression bending were completed for the Adena-Zina System in accordance with ASTM F1717-12 and Guidance for Inustry and FDA Staff: Spinal System 510(k)s issued May 3, 2004. In addition, the connectors underwent axial grip testing in accordance with ASTM F1798-13. This performance testing demonstrated that the subject device meets or exceeds performance of the predicate device.

Substantial Equivalence:

The Adena-Zina System is substantially equivalent to the cleared predicate device, the Medtronic CD Horizon Spinal System (K123809), because it has similar indications for use, is composed of the same materials, and has similar technological characteristics. In addition, the Adena-Zina system meets or exceeds the performance of the predicate device in bench tests.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.