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The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.

Inion S-1™ Biodegradable Anterior Cervical Fusion System, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion rigit fixances (10), posterinain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.

Inion S-1 ™ Biodegradable Anterior Cervical Fusion System consist of cervical spinal fusion plates and screws, and is made of resorbable polylactic acid copolymers, P(L/DL)LA 80:20.

Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years.

Inion S-1 ™ Biodegradable Anterior Cervical Fusion System is provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

The provided document is a 510(k) summary for the Inion S-1 Biodegradable Anterior Cervical Fusion System, which is a medical device. This type of document focuses on establishing substantial equivalence to previously marketed devices rather than detailing a study with acceptance criteria for device performance as would be seen for AI/ML software.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not available in the provided text.

The document states:

• "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application."
• "Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years."

This indicates that in vitro testing was performed for mechanical properties and bioresorption, but specific acceptance criteria and detailed study results from this testing are not provided in this summary. The 510(k) process for a device like this primarily relies on demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and general performance characteristics rather than specific quantitative performance criteria and clinical trial data typically associated with AI/ML software.

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