(59 days)
Matisse Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.
Matisse Anterior Cervical Interbody Fusion Cage system intended for use as an . interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA®LTlwith marker pins made of Tantalum (ASTMF 560).
The provided document is a 510(k) summary for the Matisse Anterior Cervical Interbody Fusion Cage system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format of a clinical trial for a novel AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission.
The "study" in this context refers to non-clinical (mechanical) testing used to demonstrate the device's physical properties are equivalent to devices already on the market.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic AI. Instead, it demonstrates performance by showing the device meets established ASTM standards for interbody fusion cages.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device integrity and mechanical properties meet ASTM standards for intervertebral body fusion devices. | The Matisse Anterior Cervical Interbody Fusion Cage system (tested under the name Lexus Cervical Intervertebral body Fusion Cage System K120840) was tested according to: - ASTM F 2077: Specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing. - ASTM F 2267: Specifically, Static Subsidence testing under Axial Compression. The document asserts that "the non-clinical testing conducted on the Lexus predicate [is] applicable to represent the Matisse Anterior Cervical Interbody Fusion Cage system." |
| Design, materials, and intended use are identical or similar to legally marketed predicate devices. | The Matisse Anterior Cervical Interbody Fusion Cage system is stated to be "exactly identical" to the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and "substantially equivalent" to several other predicate devices regarding design, sizes, manufacturing process, materials (PEEK-OPTIMA® LTi with Tantalum marker pins), and intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/diagnostic device's test set. For mechanical testing, this refers to the number of physical devices or components tested. The document does not specify the exact number of units tested for each ASTM standard, but implies a sufficient number were tested to satisfy the standards.
- Data Provenance: Not applicable for an AI/diagnostic device's data provenance. The testing was conducted for the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and considered applicable to the Matisse system due to their identical nature. The location of the testing laboratories is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical implant, not an AI or diagnostic device requiring expert interpretation of outputs or ground truth establishment in this manner.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is relevant for studies involving human interpretation or labeling, which is not the case for mechanical testing of an implantable device.
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 describes an MRMC study for AI/diagnostic devices, which is irrelevant to a spinal implant's 510(k) submission based on substantial equivalence and mechanical testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This concept applies to AI algorithms, not physical medical devices like the Matisse Anterior Cervical Interbody Fusion Cage system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is compliance with established ASTM mechanical testing standards (F 2077 and F 2267), which define acceptable physical and mechanical properties for intervertebral body fusion devices.
8. The sample size for the training set
Not applicable. This pertains to AI/machine learning models, not physical devices.
9. How the ground truth for the training set was established
Not applicable. As above, this is for AI/ML models.
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JUL 2 7 2012
AccessPINE
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Accel SPINE
| Accel SPINE. |
|---|
| 14850 Quorum Dr.Suite220Dallas, TX 75254,USA |
| Daniel Chon |
| Phone. 800.713.9489 |
| FAX .888.831.4892 |
| E-mail: dchon@accelspine.com |
| May 22, 2012 |
2. Device Identification
| Trade Name | Matisse Anterior Cervical Interbody Fusion Cage system |
|---|---|
| CommonName | Intervertebral Body Fusion Device |
| Classification Name | intervertebral fusion device with bone graft, cervical |
| Regulation Number | 21 CFR 888.3080 |
| Regulatory Class | Class II |
| Product Code | ODP |
3. Predicate or Legally Marketed Devices which are Substantially Equivalent
The design feature and indications for use for the subject Matisse Anterior Cervical Interbody Fusion Cage system isexactly identical to Lexus Cervical Intervertebral body Fusion Cage System cleared in K120840 and substantially equivalent to the following predicates:
- L&K Biomed Co.,Ltd.:,Lexus Cervical Intervertebral body Fusion Cage System (K 120840) �
- . LDR Spine: LDR Spine Cervical Interbody Fusion System(K091088,K113559)
- Spine Art: TRYPTIK CA Anterior Intersomatic Cervical Cage (K091873) ◆
- Advanced Medical Technologies AG: SHELL Cages (K080401) ●
- Globus Medical Inc .: COALITION TM Spacer (K083389) .
4. Description of the Device
Matisse Anterior Cervical Interbody Fusion Cage system intended for use as an . interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA®LTlwith marker pins made of Tantalum (ASTMF 560).
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CAccelSPINE
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5. Indications for Use
Matisse Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.
6. Discussion of the Non-clinical Testing
The Matisse Anterior Cervical Interbody Fusion Cage system and Lexus Cervical Intervertebral body Fusion Cage System (K 120840) is identical products. And the non-clinical testing conducted on the Lexus predicate applicable to represent the Matisse Anterior Cervical Interbody Fusion Cage system.
The Matisse Anterior Cervical Interbody Fusion Cagedevices were tested under the name of Lexus Cervical Intervertebral body Fusion Cage System (K 120840)according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.
7. Summary of Technology Characteristics
The Matisse Anterior Cervical Interbody Fusion Cage system and Lexus Cervical Intervertebral body Fusion Cage System (K 120840)identical products. Both product are same in design and sizes and all manufacturing process, materials and the same intended use.
And The Matisse Anterior Cervical Interbody Fusion Cage systemshares technological characteristics similar to the predicate devices.
These characteristics include similar design, the same materials and the same intended use.
8. Conclusion+
The Matisse Anterior Cervical Interbody Fusion Cage system is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Accel Spine, LLC % Ms. KiHyang Kim L&K Biomed Company, Limited #1104, Ace High-end Tower 3 cha, 371-50 Gasan-Dong, Geumcheon-gu, Seoul 153-803 Republic of Korea
JUL 2 7 2012
Re: K121569
Trade/Device Name: Matisse Anterior Cervical Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 22, 2012 Received: May 31, 2012
Dear Ms. Kim:
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
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Page 2- Ms. Kim
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K121569
Device Name:Matisse Anterior Cervical Interbody Fusion Cage system
Indications For Use:
Matisse Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitateintervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Anterior Cervical Interbody Fusion Cage system is to be used withsupplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use
(Part 21 CER801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CER801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OED)
Traditions 910(R)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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§ 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.