The General System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordoss), (3) spinal tumor, (4) failed previous fusion, (6) spinal stenosus. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.

Device Description

The General Spinal System consists of Fixed-Angle Reduction Screws. Rods, Cross Link and set screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, 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 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 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

The provided document is a 510(k) summary for the "General Spinal System," a pedicle screw spinal system. It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, detailed study designs (such as sample sizes, ground truth establishment, or expert qualifications), or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance studies that would be necessary to answer the questions thoroughly.

Therefore, I can only provide information based on what is available in the document.

Detailed Breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., specific load endurance values, displacement limits) that a device must meet, nor does it report specific numerical performance results for the device against such criteria.

Instead, the document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standard: ASTM F1717-04, 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."

This implies that the acceptance criteria are adherence to the ASTM F1717-04 standard's methodologies and achieving comparable performance to the predicate device(s) within the scope of these tests. Without specific data, a table cannot be constructed with numerical values.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Compliance with ASTM F1717-04 for Spinal Implant Constructs in a Vertebrectomy Model	The device's non-clinical tests demonstrated compliance with ASTM F1717-04 for static compression bending, dynamic compression bending, and static torsion tests. The device was deemed Substantially Equivalent (SE) to predicate devices based on these tests.

2. Sample size used for the test set and the data provenance

The document describes non-clinical mechanical tests. It does not involve human data or test sets in the context of clinical trials. Therefore, "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable in the context of this device's testing as described. The testing was likely conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving ground truth established by experts (e.g., radiologists, pathologists). The "ground truth" for mechanical testing is typically defined by the test standard (e.g., ASTM F1717-04) and the physical properties observed.

4. Adjudication method for the test set

This question is not applicable for the same reason as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert consensus scenarios, not for mechanical bench testing.

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

This question is not applicable. The device is a "General Spinal System" (a pedicle screw spinal system), which is a physical implant, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described, the "ground truth" refers to the established performance characteristics and requirements outlined in the ASTM F1717-04 standard for spinal implant constructs, as well as the observed mechanical properties (e.g., strength, stiffness, fatigue life) of the tested device and its predicate(s). It is purely objective mechanical measurement, not a subjective "truth" established by experts or clinical outcomes.

8. The sample size for the training set

This question is not applicable. The document describes the testing of a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The symbol is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

September 3, 2014

Changzhou Dean Medical Instrument Company, Limited % Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120, China

Re: K134011

Trade/Device Name: General Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: August 7, 2014 Received: August 11, 2014

Dear Ms. Hong:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Diana Hong

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.

Ronaldfølean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K134011

Device Name

General Spinal System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CER 801 Subpart D)

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

PLEASE DO NOT WRITE BECOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM IO THE PRA STAEE EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect: of this information collection, including suggestions for reducing this burden, to

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Exhibit #4 510(k) Summary

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K134011

1. Date of Submission: 08/06/2014
1. Sponsor Identification

Changzhou Dean Medical Instrument Co., Ltd. No. 10, Jinshajiang Road, Xinbei District, Changzhou, Jiangsu, 213125, China

Establishment Registration Number: Not yet registered

Contact Person: Xiaoqing Liu Position: Quality System Specialist Tel: +86-519-85195058 Fax: +86-519-85195058 Email: 717181584@qq.com

1. Submission Correspondent
  Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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4. Proposed Device Identification

Common Name: General Spinal System Proposed Device Name: General Spinal System Classification Name: Pedicle screw spinal system Product Code: MNI, MNH Regulation Number: 21 CFR part 888.3070 Review Panel: Orthopedic

Intended Use Statement:

The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.

న్. Predicate Device Identification
510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Manufacturer: Trauson (Jiangsu) Medical Instrument Co., Ltd.

510(k) Number: K042790 Product Name: CD HORIZON ® Spinal System Predicate Device Name: CD HORIZON LEGACY 5.5mm Spinal System Manufacturer: Medtronic SofamorDanek, Inc.USA

1. Device Description
  The General Spinal System consists of Fixed-Angle Reduction Screws. Rods, Cross Link and set screws.

It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, 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 10 by the hospital prior to surgery. The recommended sterilization method was validated E4-2

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per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standard:

ASTM F1717-04, 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.
1. Substantially Equivalent (SE) Conclusion

The General Spinal System is Substantially Equivalent to the predicate device with respect to intended use, technological characteristics and principles of operation.

Regulation Number and Section

N/A