(272 days)
The Medussa-PL Cage is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Medussa-PL Cage is comprised of a variety of implant sizes and instrumentation to accommodate various patient anatomy and pathology. All implantable components are manufactured with an additive manufacturing technology from medical grade titanium alloy Ti6Al4V-ELI per ASTM F136 and ASTM 3001. The cages are intended to be implanted via a Posterior Lumbar Intervertebral (PLIF) approach. Implants are single use and the system is provided sterile.
The provided text describes a medical device, the "Medussa-PL Cage," and its 510(k) premarket notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel algorithm or AI.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), training set specifics, and specific performance metrics for an AI/algorithm-based device cannot be extracted from this document.
This document outlines the regulatory approval process for an intervertebral body fusion device and its physical performance testing, not the performance of an AI application.
Here's an explanation of why the requested information is not available in the provided text:
- Type of Device: The "Medussa-PL Cage" is an intervertebral body fusion device, a physical implant used in spinal surgery. It is not an AI or algorithm-based software device.
- Regulatory Pathway: The document describes a 510(k) premarket notification, which is a pathway for devices that are "substantially equivalent" to legally marketed predicate devices. This process primarily involves demonstrating that the new device has the same intended use, indications for use, technological characteristics, and safety/effectiveness profiles as an already approved device. It does not typically involve defining and testing against specific acceptance criteria for an AI's diagnostic or predictive performance.
- Performance Data Provided: The "Performance Data" section details mechanical testing such as static and dynamic axial compression, compression shear, static torsion, subsidence, expulsion, and abrasion. These tests are relevant to the physical properties and structural integrity of an implant, not the accuracy or reliability of an AI algorithm.
- Ground Truth and Experts: The concepts of "ground truth," "experts," "adjudication," and "human-in-the-loop performance" are specific to the evaluation of AI/algorithm performance. They are not applicable to the physical testing of an implant.
Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance as it pertains to AI, nor any of the other AI-specific study details, because the provided document is not about an AI device.
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November 2, 2017
Medyssey Co., Ltd. % Ms. Cheryl L. Wagoner Principal Consultant/Owner Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K170341
Trade/Device Name: Medussa-PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 2, 2017 Received: October 4, 2017
Dear Ms. Wagoner:
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,
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) K170341
Device Name Medussa-PL Cage
Indications for Use (Describe)
The Medussa-PL Cage is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
| 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 (as required by 21 CFR 807.92)
| Date Prepared | 10/31/2017 |
|---|---|
| Manufacturer | Medyssey Co., Ltd. |
| Address | 129, Hanbang Expo-ro, Jecheon-si, Chungcheongbuk-do, 27116,Republic of Korea |
| Telephone | +82 43 716 1014 |
| Fax | +82 43 716 1015 |
| Contact Person | Shawn Kim |
| Address | Medyssey USA1550 E Higgins RoadSuite#123Elk Grove, IL 60007 |
| Telephone | 847-427-0200 |
| Fax | 888-518-9070 |
| shawn@medyssey.com |
| Trade Name | Medussa-PL Cage |
|---|---|
| Common Name | Intervertebral Body Fusion Device |
| Panel Code | Orthopaedics/87 |
| Classification Name | Intervertebral Body Fusion Device |
| Class | Class II |
| Regulation Number | 21 CFR 888.3080 |
| Product Code | MAX |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Medyssey LP Cage (Primary) | K110067 | Medyssey Co., Ltd |
| 4-WEB ALIF SPINAL TRUSSSYSTEM (STS) | K112316 | 4-WEB, INC. |
| Description | The Medussa-PL Cage is comprised of a variety of implant sizes andinstrumentation to accommodate various patient anatomy and pathology.All implantable components are manufactured with an additivemanufacturing technology from medical grade titanium alloy Ti6Al4V-ELIper ASTM F136 and ASTM 3001. The cages are intended to beimplanted via a Posterior Lumbar Intervertebral (PLIF) approach.Implants are single use and the system is provided sterile. |
|---|---|
| ------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Indications andIntended Use | The Medussa-PL Cage is indicated for use in skeletally mature patients withDegenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.DDD is defined as discogenic back pain with degeneration of the disc confirmedby patient history and radiographic studies. Patients should have received 6months of non-operative treatment prior to treatment with the devices. The devicemust be used with supplemental fixation. These DDD patients may also have upto Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicatedto be used with autograft bone. |
|---|---|
| --------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| TechnologicalCharacteristics andSubstantialEquivalence | Documentation was provided to demonstrate that the Subject device, Medussa-PL Cage is substantially equivalent to the Predicate Medyssey LP Cage(K110067). The Subject device is substantially equivalent to the predicate devicein intended use, indications for use, materials, technological characteristics, andlabeling. |
|---|---|
| -------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Performance Data | Static and dynamic axial compression, static and dynamiccompression shear, and static torsion were completed followingASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested following a recognized protocol to allowcomparison evaluation of intervertebral body fusion deviceassemblies, and characterize their resistance to expulsion.Abrasion testing was performed per ASTM F1978. Additionally,bone graft volume as compared to the predicate and SEMcharacterization were conducted. The above pre-clinical testing onthe Subject device indicate that the Medussa-PL Cage issubstantially equivalent to the predicate device. |
|---|---|
| Conclusion | The Medussa-PL Cage and its predicate have the same intended use, to providemechanical stability in the lumbar disc space to facilitate biologic fusion. Theindications for use of the Medussa-PL Cage are identical to the predicate. TheSubject device is similar in size as its predicate. Minor differences between theSubject and predicate devices do not raise any new questions of safety orefficacy. Bench testing demonstrated that the differences do not adversely impactdevice mechanical performance. Based on the intended use, indications for use,technological characteristics, materials, and comparison to predicate devices, theSubject Medussa-PL Cage (Subject device) has been shown to be substantiallyequivalent to legally 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.