Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. 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

Double Medical Universal Spine System consists of pedicle screws, rods, transconnector and nut etc. It is made of Ti-6A1-4V ELI, which meets ASTM F 136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and is widely used for surgical implants. The proposed devices are provided non-sterile but sterilized by the end user.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Universal Spine System." This type of document is for a medical device that has been deemed substantially equivalent to a previously cleared device. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria like a novel AI/software medical device would.

Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth establishment, training set details, and adjudication methods, is not applicable to this type of traditional medical device submission.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Tests)	Reported Device Performance
ASTM F 1717-14 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model":	Demonstrated to meet design specifications and be substantially equivalent to the predicate device. Specific numerical results are not provided in this summary but would have been included in the full submission.
- Static compression bending test	(Met)
- Dynamic compression bending test	(Met)
- Static torsion test	(Met)
ASTM F 1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants":	Demonstrated to meet design specifications and be substantially equivalent to the predicate device. Specific numerical results are not provided in this summary but would have been included in the full submission.
- Axial gripping capacity test	(Met)
Technological Characteristics Equivalence:	The device incorporates the same technological characteristics as the predicate device (Trauson General Spinal System K082617).
- FDA Product Codes: MNI and MNH	MNI and MNH
- Equivalent intended uses	Indicated for posterior, non-cervical, pedicle fixation for specified spinal conditions.
- Components are manufactured from Ti-6Al-4V ELI as per ASTM F 136	Made of Ti-6Al-4V ELI, meeting ASTM F 136.
- Polyaxial and monoaxial pedicle screws are used to attach to the vertebrae	Polyaxial and monoaxial pedicle screws are used.
- Same pedicle screw thread form configuration	Same pedicle screw thread form configuration.
- Construct support mechanism	Same construct support mechanism.
- Use of instrumentation to aid the placement of pedicle screws and rods	Uses instrumentation to aid placement.
- Mechanical performance	Mechanical performance shown to be equivalent.

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

Test Set: For the bench tests (ASTM F 1717-14 and ASTM F 1798-13), the "sample size" refers to the number of physical devices or constructs tested. This information is not provided in the summary document. It would typically be detailed in the full test reports submitted to the FDA.
Data Provenance: This refers to laboratory bench testing conducted to internationally recognized standards (ASTM standards). It is not clinical data, so concepts like "country of origin" or "retrospective/prospective" don't apply in the common sense.

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

Not Applicable. The "ground truth" for the bench tests is established by the specifications of the ASTM standards and the measurements of a testing laboratory, not by expert medical opinion. For a physical device like this, performance is measured against engineering and material science standards.

4. Adjudication Method for the Test Set

Not Applicable. As the tests are based on objective physical measurements against established standards, an adjudication method by experts is not required.

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

No. This is a hardware device (spine system), not an AI/software device. MRMC studies are used for evaluating diagnostic image interpretation by humans, often with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This is a hardware device.

7. The Type of Ground Truth Used

For the bench tests: Engineering specifications and material science standards as defined by the ASTM F 1717-14 and ASTM F 1798-13 standards.
For the overall device: Substantial equivalence to a legally marketed predicate device (Trauson General Spinal System K082617) in terms of intended use, materials, function, sizes, and mechanical test results.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this traditional hardware medical device submission. Training sets are relevant for machine learning algorithms.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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

August 22, 2016

Double Medical Technology Incorporated Mr. Da Zeng No. 18, Shanbianhong East Road, Haicang District Xiamen Fujian, 361026 CHINA

Re: K151458

Trade/Device Name: Double Medical Universal Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: July 16, 2016 Received: July 20, 2016

Dear Mr. Zeng:

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,

Vincent J. Devlin -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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Indications for Use

510(k) Number (if known) K151458

Device Name Double Medical Universal Spine System

Indications for Use (Describe)

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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Section 3 510(k) Summary

This 510(k) summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K151458

3.1 Date of Submission

July 16th, 2016

3.2 Submission Correspondent

Mr. Da Zeng Double Medical Technology Inc. No. 18, Shanbianhong East Road, Haicang District, Xiamen Fujian, China 361026 Tel: 86-592-6087078 Fax: 86-592-6587093 Email: zengda@Double-Engine.com; da52827@gmail.com

3.3 Proposed Device

Trade /Proprietary Name: Double Medical Universal Spine System Common Name: Pedicle screw spinal system Classification Name: Pedicle screw spinal system Device Classification: II Classification Panel: Orthopedic Panel Product Code: MNI, MNH Regulation Number: 21 CFR Part 888.3070

3.4 Predicate Devices Information

Trauson General Spinal System (GSS) K082617

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3.5 Device Description

3.6 Indication for Use/Intended Use

Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scollosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, 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.

3.7 Technological Characteristics

Double Medical Universal Spine System components incorporate the same technological characteristics as the predicate device to stable the non-cervical posterior spine as an adjunct to fusion. At a high level, the subject and predicate device are based on the following same or equivalent technological elements:

FDA Product Codes: MNI and MNH
Equivalent intended uses
Components are manufactured from Ti-6Al-4V ELI as per ASTM F 136
Polyaxial and monoaxial pedicle screws are used to attach to the vertebrae
Same pedicle screw thread form configuration
Construct support mechanism
Use of instrumentation to aid the placement of pedicle screws and rods ●
Mechanical performance

3.8 Non-Clinical Tests Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed per ASTM F 1717-14 "Standard Test Methods for Spinal Implant Constructs in a

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Vertebrectomy Model":

Static compression bending test
Dynamic compression bending test ●
Static torsion test. ●

And ASTM F 1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants":

Axial gripping capacity test ●

3.9 Substantially Equivalent Conclusion

The information submitted in this premarket notification has compared Double Medical Universal Spine System to the predicate device in regard to intended use, material, function, sizes and mechanical test results. These comparisons demonstrate sufficient evidence to conclude that Double Medical Universal Spine System is 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.