Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage should be packed with autogenous bone graft (i.e. autograft).

Device Description

Double Medical Cage System consists of cages of various lengths and heights, which can be inserted between two vertebral bodies to give support during interbody fusion surgeries. The cages consist of main bodies and marker pins. The main bodies are made of PEEK, which meets the requirements of ASTM F 2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Cage System," an intervertebral body fusion device.

Crucially, this document explicitly states: "No clinical performance data is included in this submission."

Therefore, I cannot provide information regarding acceptance criteria or a study proving the device meets those criteria, as no such study or data is presented in this submission.

The 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and material comparisons.

Here's what I can extract based on your request, as much as possible given the lack of clinical data:

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

Since no clinical studies or clinical performance data were provided, there are no predefined clinical acceptance criteria or reported clinical device performance to list.

The non-clinical performance data section mentions that the device met design specifications and conformed to specific ASTM standards:

ASTM F2077 Test Methods For Intervertebral Body Fusion Devices
ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

The tests conducted under these standards include:

Static axial compression test
Static compression shear test
Dynamic axial compression test
Dynamic compression shear test
Subsidence Test

However, the document does not specify the acceptance criteria (e.g., minimum load, maximum deformation) for these non-clinical tests nor the exact reported performance values of the Double Medical Cage System against those criteria. It only states that the device "met all design specifications" and "conforms" to these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical test set data is provided. For the non-clinical tests, the report does not specify the number of units tested. The data would be from laboratory testing, presumably performed in China, given the submitter's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set data is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set data is provided.

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 device is a physical intervertebral body fusion system, not an AI or imaging device that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical implant, not an algorithm.

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

Not applicable, as no clinical studies were performed or reported in this submission. For the non-clinical tests, the "ground truth" would be the expected mechanical properties and performance defined by the ASTM standards and the device's design specifications.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a physical device, not a machine learning model.

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

Not applicable. There is no mention of 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Double Medical Technology Inc. Ms. Yan Zuo Regulatory Specialist No. 18 Shanbianhong East Road, Haicang District Xiamen, 361026 CHINA

February 1, 2018

Re: K172828

Trade/Device Name: Double Medical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 10, 2018 Received: January 12, 2018

Dear Ms. Zuo:

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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) K172828

Device Name Double Medical Cage 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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510(k) Summary

Submitter

Double Medical Technology Inc. No. 18, Shanbianhong East Road, Haicang District, Xiamen, 361026, P. R. China

Tel: 86-592-6885068 Fax: 86-592-6087671 Email: intl ra@double-medical.com; zuoyan@double-medical.com

Contact Person: Yan Zuo Date Prepared: Jan. 10th, 2018

Device

Trade /Proprietary Name: Double Medical Cage System Common or Usual Name: Double Medical Cage System Classification Name: Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulatory Classification: Class II Product Code: MAX

Predicate Device

Primary predicate device:

K133053 Weigao Milestone Spinal System

Additional Predicates:

K100089 Synthes T-PAL Spacer

Device Description

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Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.

Indication for Use

Comparison with the Predicate Device

The rationale for substantial equivalence is based on consideration of the following characteristics: Regulatory Classification: Same as the predicate devices Indications for Use: Substantially equivalent (SE) to the predicate devices Materials: Substantially equivalent (SE) to the predicate devices Design Features: Substantially equivalent (SE) to the predicate devices

Non-Clinical Performance Data

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 conforms to ASTM F2077 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression, including:

Static axial compression test
Static compression shear test
Dynamic axial compression test
Dynamic compression shear test
Subsidence Test

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Clinical Performance Data

No clinical performance data is included in this submission.

Conclusion

The proposed device is compared to the predicate devices in respect of safety and effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be Substantially Equivalent (SE) 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.