(173 days)
The Omega LIF device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Omega LIF System is an intervertebral body fusion device. The subject and predicate lumbar devices are straight, bullet-nosed interbody devices designed to contain graft material and facilitate fusion between two vertebral bodies in the lumbar region of the spine.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device efficacy based on the provided text. The document is a 510(k) summary for a medical device (Omega LIF System), which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy through acceptance criteria and detailed study results.
Here's why I cannot provide the requested information:
- 510(k) vs. Clinical Efficacy Studies: A 510(k) submission primarily aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and technological characteristics, or if there are differences, they do not raise new questions of safety and effectiveness. It does not typically require extensive clinical trials or the establishment of detailed acceptance criteria for performance in the way a Pre-Market Approval (PMA) would.
- Lack of Specific Acceptance Criteria: The document mentions "non-clinical mechanical testing" and specific ASTM standards (F2077) for static/dynamic axial compression and compression shear, as well as subsidence, expulsion, and wear testing. However, it does not provide numerical acceptance criteria (e.g., "device must withstand X Newtons of force" or "subsidence must be less than Y mm"). It only states that the "Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device."
- No Clinical Study Details: There are no details about a clinical study involving human subjects that assesses the device's performance against pre-defined acceptance criteria for clinical outcomes. The document explicitly states the device is for intervertebral body spinal fusion procedures. While this implies clinical outcomes, the 510(k) summary itself does not contain the study to demonstrate those outcomes.
- No Information on AI/Algorithm Performance: Your request includes questions about AI performance, multi-reader multi-case studies, standalone algorithm performance, and training/test set details. The provided document concerns a physical medical implant (intervertebral body fusion device) and does not involve AI or algorithms in its described testing or equivalence claims.
In summary, the provided document is a regulatory submission focused on substantial equivalence based on technological characteristics and mechanical testing, not a detailed clinical study report with performance acceptance criteria for human efficacy.
Therefore, I cannot extract information regarding:
- A table of acceptance criteria and reported device performance (beyond a general statement of substantial equivalence).
- Sample sizes, data provenance, expert ground truth, or adjudication methods for clinical test sets.
- MRMC studies, effect sizes of AI assistance, or standalone algorithm performance.
- Type of ground truth used for clinical outcomes.
- Training set details for algorithms.
If you have a document that describes a clinical study or performance evaluation with specific acceptance criteria, I would be happy to try and extract that information for you.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015
Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Consultant 1755 West Oak Parkway Marietta, Georgia 30062
Re: K150395
Trade/Device Name: Omega LIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 20, 2015 Received: July 21, 2015
Dear Ms. Allen:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Kristen Allen
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" (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 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 vours.
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) K150395
Device Name Omega LIF System
Indications for Use (Describe)
The Omega LIF device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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 | |
|---|---|
| Omega LIFÁ | |
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| ÁDate Prepared: | Œ *˘ • cÁ Ê´GÊFÍ Á |
| Trade Name:ÁÁ | U{ ^*æŠØÁÚ^•c^{ Á |
| Common Name:Á | Qe¦ç\c^¦c^¦à¦æ[ å˜ Á^•ã } Á^çã&^ |
| Device Product Codeand Classification: | T ŒÝʌƽFÁO QÜÂ Ì Ì ÈHÌ €ÑÔ¦œ• Á¤Qe¦ç\c^¦c^¦à¦æ½Ó[ å˜ Áؘ•ã } ÁÖ^çã&^ÁÁ |
| Primary Predicate Device:ÁÁ | Z^ˇ • ÁQe¦ç\c^¦c^¦à¦æ½Ø˜•ã } ÁÖ^çã&^•ÁS€Ì FÎ FI D |
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Indications and Intended use:
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Image /page/4/Picture/0 description: The image shows the word "Amendia" in blue font. The letter "A" is enclosed in a blue square. A grey line is located underneath the word.
The Elements of Healing
of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Summary of Technological Characteristics:
The subject Omega LIF is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function. Both the subject and predicate lumbar devices are straight, bullet-nosed interbody devices designed to contain graft material and facilitate fusion between two vertebral bodies in the lumbar region of the spine.
Summary of Performance Testing:
Non-clinical mechanical testing for the Omega LIF system was performed on the worst case subject device. Testing included static and dynamic axial compression (ASTM F2077), Static and Dynamic Compression Shear (ASTM F2077), subsidence, expulsion, and wear testing. Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device.
Conclusion:
Based on the comparison to predicate devices and performance testing, the Omeqa LIF device has been shown to be substantially equivalent to leqally marketed predicate devices.
§ 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.