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MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.

MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.

The provided text describes information about the MCI-Neuro Fixation System, a cranial fixation device. However, it does not contain the kind of detailed information about acceptance criteria, clinical study design, sample sizes, expert qualifications, or comparative effectiveness studies that your request asks for, especially concerning an AI/ML-driven device.

The document discusses:

• Regulatory Clearance (K212391): It's a 510(k) premarket notification for a Class II medical device.
• Device Description: The system consists of plates, screws, and meshes made from titanium.
• Predicate Device: K141911 - OPTIMUS NEURO SYSTEM.
• Performance Data: This section focuses on bench testing for physical and material properties (metallographic tests, cyclic polarization, cycle bend testing of plates, screw torsion yield test, pull-out testing, driving torque testing).
• Biocompatibility: Stated as supported by a reference device (K182758).
• Lack of Clinical Data: Explicitly states, "No clinical data were included in this submission."

Since this device is a physical fixation system and not an AI/ML driven diagnostic or prognostic tool, the concepts of human readers, AI assistance, ground truth establishment (beyond material specifications), training sets, and test sets in the context of diagnostic accuracy are not applicable to this document.

Therefore, I cannot provide a table of acceptance criteria and device performance, or details about clinical study design, sample sizes, expert qualifications, or adjudication methods as requested, because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence through material and mechanical bench testing.

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MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "MCI - CMF System," which consists of bone plates and screws. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of design, materials, indications for use, and a limited set of mechanical and biocompatibility tests.

There is no mention of an AI/algorithm-driven device, nor are there any acceptance criteria or studies related to AI model performance, accuracy, or human-in-the-loop studies involving expert readers.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm. The provided text simply does not contain this information.

To elaborate on why I cannot answer based on the provided text:

• No AI/Algorithm: The "MCI - CMF System" is a physical medical implant (bone plates and screws). It is not software, an algorithm, or an AI system.
• No Diagnostic Claims: The device is for "selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin." These are surgical indications, not diagnostic. There's no AI that would be "reading" images or assisting in diagnosis.
• No Acceptance Criteria for AI Performance: Since it's a physical implant, the "performance" data refers to mechanical testing (e.g., bending fatigue of plates, pullout strength of screws) and biocompatibility, not AI metrics like sensitivity, specificity, AUC, or reader studies.
• No Test Set Details: There's no test set of patient data, as there's no AI to evaluate on such data.
• No Expert Ground Truth or Adjudication: These concepts are relevant for evaluating AI in diagnostic imaging or clinical decision support, which is not the function of this device.
• No MRMC or Standalone AI Study: These are types of studies specifically for AI performance evaluation.
• No Training Set Information: Again, training sets are for machine learning models, which are not described in this document.

The 510(k) summary concludes that the device is substantially equivalent based on engineering principles, material science, and the stated indications for use, compared to predicate devices already on the market.

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