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The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer is made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System also includes bone screws to secure the device to the vertebral body.

This document is a 510(k) Premarket Notification from the FDA regarding the "Reliance Cervical IBF System." It is primarily a regulatory approval document and does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested for AI/medical device performance evaluation.

The document pertains to an intervertebral body fusion device and confirms its substantial equivalence to previously marketed predicate devices (K120396, K131429, K142269 & K172489). The "Non-Clinical Testing" section mentions that the system has undergone mechanical testing according to ASTM standards (ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02). However, it does not provide specific acceptance criteria or performance results from these tests. These are standard tests for mechanical integrity of implants, not for AI performance.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions regarding sample size, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, and training set information are all relevant to the evaluation of AI models or diagnostic devices, which this document does not describe. This is a physical implant device, not an AI or diagnostic software.

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The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non- operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).

I am sorry, but the provided text is a 510(k) summary for a medical device (ShurFit CpTi-HA ACIF Interbody Fusion System). It describes the device, its indications for use, and a comparison to predicate devices, including a brief summary of non-clinical tests performed.

However, this document does not contain information about:

• Acceptance criteria
• A study that proves the device meets acceptance criteria.
• Reported device performance values against specific criteria.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and mechanical testing according to established ASTM standards for interbody fusion devices and coatings. It details what tests were performed on the device and its coating (e.g., Static Axial Compression, Static Tensile Bond Strength), but not the specific quantitative results or how those results compare to pre-defined acceptance criteria for a "study that proves the device meets the acceptance criteria."

Therefore, I cannot fulfill your request for the specific details you've asked for based on the provided text. This document is a regulatory submission for device marketing clearance, not a clinical study report or a detailed performance validation study report.

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