In addition, when used as a pedicle screw fixation system, the Zeus Spinal 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 Zeus Spinal System is a modification of the previously cleared Adena-Zina Spinal System which consists of a variety of shapes and sizes of screws and Ø5.35mm 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 the originally cleared (K152781) straight and pre-bent rods, fixed and fixed angle reduction screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066). The subject submission seeks to add new Ø5.5mm pre-bend rods, single head and dual head polyaxial (multi-axial) screws, dual head reduction screws, polyaxial reduction screws (fixed polyaxial fixed screws, dual head monoaxial (fixed) screws, cannulated reduction screws (multiaxial and monoaxial), coronal and sagittal uniplanar screws, preferable angle screws, iliac screws, monoaxial Screw, associated set screws, connector and Ø5.5mm crosslinks, as well as additional sizes of existing components and cobalt chrome tulips for associated screws.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Zeus Spinal System," a thoracolumbosacral pedicle screw system. This document focuses on demonstrating substantial equivalence to predicate devices through bench performance testing of the device itself (implants), rather than evaluating the performance of an AI/software component in a human-in-the-loop or standalone study with a ground truth established by experts.

Therefore, many of the typical acceptance criteria and study details relevant to AI/software device performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission as described.

Here's a breakdown based on the provided text:

Subject of Evaluation: Physical medical device (spinal implants and their mechanical performance), not an AI/software algorithm.

Type of Study: Bench performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance bench testing was performed "per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and "per ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used in Spinal Arthrodesis Implants."

While the specific numerical acceptance criteria and reported performance values are not explicitly detailed in this public summary, the conclusion states: "performance bench testing had been performed and shows that the subject Zeus Spinal System performs equivalent to or better than the primary predicate device."

Acceptance Criteria (General)	Reported Device Performance (Summary)
Meet or exceed performance standards of ASTM F1717	Performed equivalent to or better than the primary predicate device
Meet or exceed performance standards of ASTM F1798	Performed equivalent to or better than the primary predicate device
Static axial compression strength	Performed equivalent to or better than the primary predicate device
Dynamic axial compression strength	Performed equivalent to or better than the primary predicate device
Static torsion resistance	Performed equivalent to or better than the primary predicate device
Screw dissociation resistance (static and fatigue)	Performed equivalent to or better than the primary predicate device

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in the document. For bench testing of physical devices, sample sizes are typically defined by engineering standards (like ASTM) to ensure statistical significance for mechanical properties.
Data Provenance: Not applicable in the context of clinical data. This is mechanical testing of manufactured devices in a lab setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Ground truth for mechanical device performance is established by standardized testing protocols and measurements, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication of clinical data is involved.

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 not an AI-assisted diagnostic or clinical decision support device.

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:

Bench Testing Standards/Specifications: The "ground truth" for the device's mechanical performance is defined by the requirements outlined in the ASTM F1717 and ASTM F1798 standards, and comparison to the performance of the predicate device. These standards specify how the device should perform under various loads and conditions.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is involved.

In summary: The provided document is a regulatory submission for a physical medical device (spinal system) based on material and mechanical performance equivalency to predicate devices, conducted via standardized bench testing. It does not involve AI or software performance evaluation, and thus, metrics related to clinical data, expert review, or machine learning model performance are not relevant or present in this specific regulatory summary.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in a smaller font.

October 10, 2023

Shanghai Sanyou Medical Co, LTD % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112

Re: K230961

Trade/Device Name: Zeus Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 11, 2023 Received: September 11, 2023

Dear Christine 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image contains the text "Colin O'neill -S" in black font on the left side of the image. On the right side of the image, the letters "FDA" are written in a light blue font. The letters "FDA" are much larger than the text on the left side of the image.

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230961

Device Name Zeus Spinal System

Indications for Use (Describe)

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 Zeus Spinal System 4 April 2023

Company:	Manufacturing Facility and Headquarters:Shanghai Sanyou Medical Co, LTD385 Huirong Road, Jiading District,Shanghai 201815Phone: 021-58389980
	Manufacturing Facility:Shanghai Sanyou Medical Co, LTD385 Huirong Road, Jiading District,Shanghai 201815Phone: 021-58389980
Company Contact:	David FanVP Marketingdavid.fan@sanyou-medical.comPhone: +86 21 58389980Fax: +86 21 59990826
Official Correspondent:	Christine Scifert - MRC Global, LLCChristine.scifert@askmrcglobal.com901-831-8053
Trade Name:	Zeus Spinal System
Common Name:	Thoracolumbosacral pedicle screw system
Classification:	Class II
Regulation Number:	21 CFR 888.3070 (Thoracolumbosacral pedicle screw system)
Panel:	Orthopedic
Product Code:	NKB

Device Description:

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Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, fixed and fixed angle reduction screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066)

The subject submission seeks to add new Ø5.5mm pre-bend rods, single head and dual head polyaxial (multi-axial) screws, dual head reduction screws, polyaxial reduction screws (fixed polyaxial fixed screws, dual head monoaxial (fixed) screws, cannulated reduction screws (multiaxial and monoaxial), coronal and sagittal uniplanar screws, preferable angle screws, iliac screws, monoaxial Screw, associated set screws, connector and Ø5.5mm crosslinks, as well as additional sizes of existing components and cobalt chrome tulips for associated screws.

Indications for Use:

The Zeus Spinal 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 Zeus Spinal 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.

Substantial Equivalence:

The subject Zeus Spinal System is substantially equivalent to the following predicate devices: Primary Predicate:

Shanghai Sanyou Adena-Zina System – K152781

Secondary Predicates:

Shanghai Sanyou Adena-Zina System K212066 ●
. Medtronic CD Horizon Spinal System– K201407
DePuy Spine, Inc. EXPEDIUM® Spine System – K102249

There are insignificant differences between the subject Zeus Spinal System and the predicate devices. The Indications for Use and Materials for predicate devices are all inclusive of the subject device, with the subject device materials and indications being identical to the primary predicate Adena-Zina System (K152781). While Zeus Spinal System does include size offering/geometry outside of the predicate offerings, performance bench testing had been performed and shows that the subject Zeus Spinal System performs equivalent to or better than the primary predicate device. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

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Performance Testing:

Bench performance testing was performed on the subject Zeus Spinal System implants including static axial compression, dynamic axial compression, and static torsion per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Additionally, screw dissociation testing was performed per ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Propertied of Interconnection Mechanism and Subassemblies Used in Spinal Arthrodesis Implants

Conclusion:

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

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.