(104 days)
The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.
This document is a 510(k) premarket notification for a medical device and therefore describes a medical device (intervertebral body fusion device) rather than an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of mechanical and material performance standards and non-clinical testing, rather than AI/ML performance metrics, ground truth, or reader studies.
Here's an analysis based on the provided document, addressing the closest equivalents to your prompts for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through a series of standardized non-clinical mechanical tests. The performance is deemed acceptable if the device meets or exceeds the requirements of these ASTM standards, indicating similar mechanical safety and performance to the legally marketed predicate devices.
| Acceptance Criteria (Required Test per ASTM Standard) | Reported Device Performance (Conclusion) |
|---|---|
| Static and dynamic compression (ASTM F2077) | The results indicate equivalence to predicate devices. |
| Static and dynamic compression shear (ASTM F2077) | The results indicate equivalence to predicate devices. |
| Static and dynamic torsion (ASTM F2077) | The results indicate equivalence to predicate devices. |
| Subsidence (ASTM F2267) | The results indicate equivalence to predicate devices. |
| Expulsion testing (ASTM Draft Standard F-04.25.02.02) | The results indicate equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of the number of device units tested. For mechanical testing, samples are typically device prototypes or finished products. ASTM standards dictate the number of samples required for each test.
- Data Provenance: The document does not specify the country of origin of the data beyond the fact that the testing was conducted for a device seeking approval in the United States. The testing is prospective in the sense that physical devices were manufactured and subjected to controlled laboratory tests, rather than analyzing historical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to a non-AI/ML medical device. Ground truth, in the context of device performance, is established by adherence to engineering principles, material science, and the relevant ASTM (American Society for Testing and Materials) standards. The "experts" would be the engineers and technicians skilled in conducting the mechanical tests and interpreting the results according to the specified standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Mechanical testing involves quantitative measurements against defined standards, not subjective interpretations requiring adjudication among human observers.
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 is a traditional medical device, not an AI-powered diagnostic or assistive tool. No human reader studies were conducted or are relevant to its approval.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical intervertebral body fusion device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM standards). These standards define the expected physical properties and responses of materials and devices under simulated conditions relevant to their intended use. For example, the "ground truth" for compression strength is the maximum force the device can withstand before failure, measured according to ASTM F2077.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable.
Summary of Relevant Information from the Document:
The provided document describes the Gemini-C Hybrid Cervical Interbody System, an intervertebral body fusion device.
- Acceptance Criteria for Device Type: Substantial equivalence to predicate devices regarding intended use, design, materials, mechanical safety, and performance, demonstrated through non-clinical testing.
- Study Proving Acceptance: A series of non-clinical, mechanical tests were conducted per established ASTM standards:
- Static and dynamic compression (ASTM F2077)
- Static and dynamic compression shear (ASTM F2077)
- Static and dynamic torsion (ASTM F2077)
- Subsidence (ASTM F2267)
- Expulsion testing (ASTM Draft Standard F-04.25.02.02)
- Conclusion: The results of these evaluations indicated that the Gemini-C Hybrid Cervical Interbody System is equivalent to predicate devices, thus meeting the acceptance criteria for market clearance.
- Clinical Studies: "No clinical studies were performed." This is common for 510(k) devices when substantial equivalence can be demonstrated through non-clinical means.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osseus Fusion Systems, LLC % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
July 3, 2017
Re: K170844
Trade/Device Name: Gemini-C Hybrid Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 5, 2017 Received: June 7, 2017
Dear Mr. Webb:
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-
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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 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/ResourcesforYou/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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
K170844
Device Name
Gemini-C Hybrid Cervical Interbody System
Indications for Use (Describe)
The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
ا Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: Gemini-C Hybrid Cervical Interbody System
| Date Prepared | June 5, 2017 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC2703 Mockingbird Lane, Suite 102Dallas, TX 75235214-395-0100 Teleemail: rpace@osseus.com |
| Primary Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net |
| Trade Name | Gemini-C Hybrid Cervical Interbody System |
| Common Name | intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | • CONSTRUX Mini PEEK Ti Spacer System (K150619) |
| Additional PredicateDevices | • Crystal Cervical Cage (K073351)• Endoskeleton® TC (K100889)• BAK/Cervical Interbody Fusion (P980048)• Fusion Advantage Interbody Cages, (K083425)• Brantigan I/F Cage (P960025)• LDR Spine Cervical Interbody Fusion System (K091088)• Nanovis FortiCore™ (K140280)• 4-Webb Cervical STS Interbody Fusion Device (K121741) |
| Device Description | The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used tomaintain disc space distraction in skeletally mature adults requiring intervertebral bodyfusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range offootprints and heights to suit the individual pathology and anatomical conditions of thepatient. The implants have a hollow center to allow placement of bone graft. |
| Materials | • SOLVAY ZENIVA ZA-500 PEEK (ASTM F2026)• Ti-6A-4V ELI (ASTM F136)• Tantalum (ASTM F560)• Stainless steel (ASTM F899) |
| SubstantialEquivalence Claimedto Predicate Devices | The Gemini-C Hybrid Cervical Interbody System is substantially equivalent to thepredicate devices in terms of intended use, design, materials used, mechanical safety andperformances. |
| Indications for Use | The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusionprocedures in skeletally mature patients with degenerative disc disease (DDD) at one ortwo contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerativedisc disease (DDD) is defined as neck pain of discogenic origin with degeneration of thedisc confirmed by patient history and radiographic studies. This device is intended for usewith autogenous bone graft and/or allograft comprised of cancellous and/orcorticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such asthe White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at leastsix weeks of non-operative treatment prior to treatment with intervertebral cages. |
| Non-clinical TestSummary | The following analyses were conducted:• Static and dynamic compression (ASTM F2077)• Static and dynamic compression shear (ASTM F2077)• Static and dynamic torsion (ASTM F2077)• Subsidence (ASTM F2267)• Expulsion testing (ASTM Draft Standard F-04.25.02.02)The results of these evaluations indicate that the Gemini-C Hybrid Cervical InterbodySystem is equivalent to predicate devices. |
| Clinical TestSummary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Osseus Fusion Systems, LLC considers the Gemini-C Hybrid Cervical Interbody Systemto be equivalent to the predicate devices listed above. This conclusion is based upon thesimilarities between the Gemini-C and predicates in terms of principles of operation,technology, materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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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.