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The Gemini Cervical Fusion Cage System is indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one levels from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Gemini Cervical Fusion Cage System requires additional supplemental fixation cleared for the cervical spine. The Gemini Cervical Fusion Cage System is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

The Gemini Cervical Fusion Cage Systeme is an anterior cervical interbody device consisting of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an open, anterior approach.

The Gemini Cervical Fusion Cage System is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The radiolucent PEEK-OPTIMA®material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ISO13782 to permit verification of position. The Gemini Cervical Fusion Cage System is provided sterile via gamma irradiation for single use.Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is an FDA 510(k) clearance letter for a medical device called the "Gemini Cervical Fusion Cage System," which is an intervertebral body fusion device. The clearance is based on the substantial equivalence to a predicate device, focusing on:

• Mechanical performance: Verified through testing per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, compression shear, torsional testing, and subsidence testing. The document states that "Test results meet the acceptance criteria described in ISO 23089-2 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices."
• Material: PEEK-OPTIMA® LT1 with tantalum markers, which is a common material for such implants.
• Design features: Graft windows, serrations, and comparable dimensions to the predicate.
• Sterilization: Gamma irradiation for single use.
• Intended Use and Indications for Use: Defined for anterior cervical interbody fusion procedures for cervical disc disease.

There is no mention of an AI/ML component, diagnostic performance, human readers, ground truth establishment, or any of the other criteria you listed that would be relevant to an AI/ML-driven device evaluation (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications for ground truth).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided.

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