The Gemini Medical Cage 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. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Device Description

Gemini Medical Cage System is manufactured from a biocompatible polymer (Polyetheretherketone (PEEK)) material embedded with radiopaque tantalum marker pins, which allow the surgeon to radiographically determine the position of the implant, both intraoperatively and postoperatively. The System consists of PEEK lumbar cages of various shape and size, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries.They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The top surface of the cages have anatomical design, parallel design and wedge-shaped design respectively to adapt various vertebrae anatomical scenarios. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages are sterile provided and for single use. There are six models to accommodate different types of superior and inferior end plates depending on their technical design and shape, LF-I, LF-II, LF-III, LF-IV, LF-V and LF-VI. LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II has flat top and bottom tooth surface, LF-III and LF-V have flat or wedge-shaped surface. LF-III, LF-IV and LF-V cages have a convex angle.

AI/ML Overview

Here's an analysis of the provided text regarding the Gemini Medical Cage System, structured to answer your questions.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than comprehensive clinical trials proving efficacy de novo. Therefore, many of your questions about AI study design (like ground truth, expert adjudication, MRMC studies, training/test sets) are not applicable to this type of traditional medical device clearance for an orthopedic implant.

This document focuses on demonstrating that the Gemini Medical Cage System performs equivalently to existing devices through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative way for each test in a pass/fail format with specific thresholds. Instead, it lists the bench tests performed according to ASTM standards and implies that the device met the requirements of these standards to demonstrate substantial equivalence to predicate devices. The "reported device performance" is the successful completion of these tests, indicating compliance with the relevant ASTM standards for intervertebral body fusion devices.

Test Type	Standard Applied	Reported Device Performance
Static Axial Compression Testing	ASTM F2077	Performance-bench test completed, demonstrating substantial equivalence.
Dynamic Axial Compression Testing	ASTM F2077	Performance-bench test completed, demonstrating substantial equivalence.
Static Compression Shear Testing	ASTM F2077	Performance-bench test completed, demonstrating substantial equivalence.
Dynamic Compression Shear Testing	ASTM F2077	Performance-bench test completed, demonstrating substantial equivalence.
Subsidence Test	ASTM F2267	Performance-bench test completed, demonstrating substantial equivalence.

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

Sample Size: The document does not specify the exact number of devices tested for each bench test. For mechanical bench testing, the sample size is determined by the specific ASTM standard and statistical requirements for device qualification, but these details are not provided in this 510(k) summary.
Data Provenance: The data is from non-clinical bench testing performed on the devices themselves. There is no patient data involved in this type of submission for this device. The tests were likely conducted by or for ZheJiang Decans Medical Devices Co., Ltd., which is based in China.

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 mechanical orthopedic implant, not an AI/software device that requires expert-established ground truth from medical images or clinical data. The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ASTM standards for mechanical properties).

4. Adjudication Method for the Test Set

Not Applicable. As this is not a study involving human interpretation or subjective assessments, there is no adjudication method in the traditional sense. The "adjudication" is whether the device passed the objective criteria of the specified ASTM bench tests.

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 (intervertebral body fusion device), not an AI software. Therefore, no MRMC studies or AI-assisted performance evaluations were conducted or are relevant.

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 or software.

7. The Type of Ground Truth Used

Engineering Standards and Biocompatibility Testing: The "ground truth" for this device's performance demonstration lies in its compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267) and the biocompatibility of its materials (PEEK and tantalum markers). The goal is to show that the device is mechanically and biologically equivalent to predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI software requiring a training set.

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

Not Applicable. This is a physical medical device, not an AI software requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2024

ZheJiang Decans Medical Devices Co., Ltd. % Xiaoqing Xue Registration Engineer Sinow Medical AS Vestre Fantoftåsen 44 Bergen, 5072 Norway

Re: K242267

Trade/Device Name: Gemini Medical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 1, 2024 Received: August 1, 2024

Dear Xiaoqing Xue:

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.

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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" (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 (OS) 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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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).

Sincerely,

Brent Showalter -S

Brent Showalter, Ph.D. 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) K242267

Device Name Gemini Medical Cage System

Indications for Use (Describe)

The Gemini Medical Cage 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. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be sketally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

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

Preparation Date:	Sep. 25, 2024
Submitter	ZheJiang Decans Medical Devices Co., Ltd.
	No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing
	City, Zhejiang Province, 314031,P.R. China
	Haifeng Liu, Registration Manager
Contact	ZheJiang Decans Medical Devices Co., Ltd.
	No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing
	City, Zhejiang Province, 314031,P.R. China
	Postcode: 314031
	Email: hfliu@decansmd.com
	Phone:+86 15210058659
DesignatedSubmissionCorrespondent	Company: Sinow Medical AS
	Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway
	Contact Person: Xiaoqing Xue
	Telephone: +86 15161196032
	Email: xue@bergemed.com
Subject Device	Trade name	Gemini Medical Cage System
	Regulatory Class	II
	Regulation Number	21 CFR 888.3080
	Classification Name	Intervertebral body fusion device
	Product Codes	MAX
	Common name forproduct codes	Intervertebral fusion device with bone graft,lumbar
Primary PredicateDevice	Manufacturer	Medtronic Sofamor Danek USA. Inc.
	Trade name	CAPSTONE SPINAL SYSTEM
	510(K) number	K073291
	Regulatory Class	II
	Regulation Number	21 CFR 888.3080
	Classification Name	Intervertebral body fusion device
	Product Codes	MAX
Additional PredicateDevices	Manufacturer	DePuy Synthes
	Trade name /510(K)number	K101923, CONCORDE CURVE SYSTEM
		K100089, SYNTHES T-PAL SPACER
		K072791, SYNTHES ORACLE PLATE
	Regulatory Class	II
	Regulation Number	21 CFR 888.3080
	Product Codes	MAX
	Classification Name	Intervertebral body fusion device
Additional PredicateDevice	Manufacturer	Medtronic Sofamor Danek USA. Inc.
	Trade name	CLYDESDALE SPINAL SYSTEM
	510(K) number	K132897
	Regulatory Class	II
	Regulation Number	21 CFR 888.3080
	Product Codes	MAX
	Classification Name	Intervertebral body fusion device
Indications for use	The Gemini Medical Cage 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. These DDD patients may also
	have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved
	levels. These patients should be skeletally mature and have had six
	months of non-operative treatment. These devices are intended to be
	used with supplemental fixation.
Device Description	Gemini Medical Cage System is manufactured from a biocompatible
	polymer (Polyetheretherketone (PEEK)) material embedded with
	radiopaque tantalum marker pins, which allow the surgeon to
	radiographically determine the position of the implant, both
	intraoperatively and postoperatively. The System consists of PEEK
	lumbar cages of various shape and size, which can be inserted between
	two lumbar or lumbosacral vertebral bodies to give support and
	correction during lumbar interbody fusion surgeries.They are designed
	with angular teeth to allow the implant to grip the superior and inferior
	end plates. The top surface of the cages have anatomical design, parallel
	design and wedge-shaped design respectively to adapt various vertebrae
	anatomical scenarios. The hollow geometry of the implants allows them
	to be packed with autogenous bone graft in lumbar interbody fusion
	procedures. The cages are sterile provided and for single use.
	There are six models to accommodate different types of superior and
	inferior end plates depending on their technical design and shape, LF-I,
	LF-II, LF-III, LF-IV, LF-V and LF-VI.
	LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II
	has flat top and bottom tooth surface, LF-III and LF-V have flat or
	wedge-shaped surface.
	LF-III, LF-IV and LF-V cages have a convex angle.
Summary ofindication for useand technologicalcharacteristics	The Gemini Medical Cage System is substantially equivalent to the
	predicate devices when evaluating indication for use and technological
	characteristics.
	The subject device has the identical indication for use as the predicate
	device. The subject device and predicate devices are substantially
	equivalent, differences do not raise new questions of safety and
	effectiveness.
Non-clinical test	Performance-bench test including:
	Static Axial Compression Testing per ASTM F2077
	Dynamic Axial Compression Testing per ASTM F2077
	Static Compression Shear Testing per ASTM F2077
	Dynamic Compression Shear Testing per ASTM F2077
	Subsidence Test per ASTM F2267
SubstantialEquivalence	The Gemini Medical Cage System is substantially equivalent to the
	predicate devices when evaluating indication for use and technological

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	characteristics with only minor differences. These differences do notraise new questions of safety and effectiveness.
Conclusion	The non-clinical data demonstrates the Gemini Medical Cage System is
	substantially equivalent to the predicate device.

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.