Gemmed® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fision. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Device Description

The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Gemmed® pedicle screw spinal system." It is a regulatory submission to the FDA. The document focuses on establishing substantial equivalence to a predicate device through non-clinical bench testing. Therefore, it does not contain the detailed information typically found in a clinical study report or a study evaluating AI device performance.

Based on the provided text, I can infer the following:

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

Acceptance Criteria (Standard)	Device Performance (Test type performed)
ASTM F1717-13: Spinal Implant Constructs in a Vertebrectomy Model (All items within the standard)	Static compression bending test completed
ASTM F1717-13: Spinal Implant Constructs in a Vertebrectomy Model (All items within the standard)	Dynamic compression bending test completed
ASTM F1717-13: Spinal Implant Constructs in a Vertebrectomy Model (All items within the standard)	Static torsion test completed
(Implied) Biocompatibility per ASTM F136	Materials (Ti6Al4V ELI) meet ASTM F136 standard
(Implied) Sterilization efficacy (SAL of 10^-6)	Sterilization method validated per ISO 17665-1

Note: The document states that the proposed device "meet all design specifications as was Substantially Equivalent (SE) to the predicate device." It also says, "The test results demonstrated that proposed device complies with the following standards." However, it does not provide specific quantitative acceptance criteria or detailed numerical performance data from the conducted bench tests. It merely lists the tests performed and implies compliance with the referenced standards.

The remaining questions (2-9) are related to clinical studies and AI performance, which are not relevant to this 510(k) submission for a pedicle screw spinal system. This document describes a traditional 510(k) submission based on substantial equivalence through material properties and mechanical bench testing, not a study evaluating software or AI performance with human readers, ground truth, or training/test sets as would be applicable to an AI/ML medical device.

Therefore, for questions 2 through 9, the answer is: Not applicable or not provided in this document.

Summary

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

Suzhou Gemmed Medical Instrument Company, Limited % Ms. Alice Gong Shanghai Yarui Consulting Company, Limited 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, China 200233

September 24, 2015

Re: K151592

Trade/Device Name: Gemmed® pedicle screw spinal system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: June 22, 2015 Received: June 29, 2015

Dear Ms. Gong:

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

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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/Resourcesfor You/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)

K151592

Device Name Gemmed® Pedicle screw spinal system

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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JMR 苏州吉美瑞医疗器械有限公司

Section 5 of Traditional 510(K) Submission:

510 (K) Summary

This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92

1. Date of Submission: Feb. 28, 2015
1. Submitter / 510(K) Holder

Suzhou Gemmed Medical Instrument Co., Ltd. A22 &26, Science &Technology Development Zone, Jinnan Rd., Jinfeng Town Zhangjiagang City, Jiangsu Province, China 215625

Contact Person: Miss Alice Gong Tel: (86) 021-64957283 Fax: (86) 021-64957283 E-mail: chinafda168@163.com

3. Proposed Device Name

Trade name: Gemmed® pedicle screw spinal system Common name: Pedicle screw spinal system

Classification Name: Pedicle screw spinal system Device Class: Class II Classification Panel: Orthopedic Panel Product Code: MNI, MNH Regulation Number: 21 CFR part 888.3070

4. Primary Predicate Device

510 (k) Number: K140053 Product Name: Kangli® pedicle screw spinal system Submitter: Suzhou Kangli Orthopaedics Instrument Co., Ltd.,

5. Device Description

The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc.

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It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

6. Indication for Use/Intended Use

Gemmed " pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

7. Non-Clinical Testing

Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:

ASTM F1717-13, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:

- Static compression bending test;
- Dynamic compression bending test;
- Static torsion test.

8. Substantially Equivalent Conclusion

The Gemmed® pedicle screw spinal system has same intended use than the predicate device and similar technological characteristics as the predicate device, the Gemmed® pedicle screw spinal system, is determined to be Substantially Equivalent (SE) to the predicate device, K140053 Kanglis pedicle screw spinal system.

Regulation Number and Section

N/A