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The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.

The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

It appears you've provided a 510(k) Premarket Notification document for a medical device: the Vilex Cannulated Hemi Implant (CHI).

However, this document describes a joint implant, not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. The acceptance criteria and supporting studies described in this document relate to the mechanical performance and biocompatibility of a physical implant, not the performance of an algorithm or the accuracy of a diagnostic reading.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic or image analysis device (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

The performance data section (VII. Performance Data) for this implant focuses on:

• Engineering analyses: Bending Stress, Shear Stress, Geometric Analysis, Surface Area Analysis. These are tests to ensure the physical implant is strong enough and fits correctly.

It does not contain information relevant to AI/diagnostic device evaluation, such as:

• A table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set of diagnostic images.
• Data provenance for diagnostic images.
• Number of experts for ground truth of diagnostic images or their qualifications.
• Adjudication methods for diagnostic ground truth.
• MRMC studies to show human reader improvement with AI.
• Standalone performance of an algorithm.
• Type of ground truth (e.g., pathology, outcomes data) for diagnostic purposes.
• Training set sample size for an AI model.
• How ground truth for a training set was established for an AI model.

In summary, this document is about a physical orthopedic implant, not an AI or diagnostic software. Therefore, it does not contain the information you are requesting about AI device evaluation methods.

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The EzFuze Implants have the following Indications for Use:
Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex EzFuze Implant System includes single-piece devices intended for the fixation of PIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbed prongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the other end includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight or with a 10° bend.

This document is a 510(k) summary for the EzFuze™ Implant System. It outlines the device's indications for use, technological characteristics, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or any study details that would typically be described in an AI/algorithm-based device submission.

This is a submission for a physical medical device (an implant for bone fixation), not an AI-powered software or diagnostic tool. Therefore, the questions related to AI device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.

Based on the provided text, I cannot provide the requested information because the document describes a physical medical implant, not an AI software/device.

To answer your request, I would need a document related to an AI/algorithm-based medical device.

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The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.

The provided text is a 510(k) Summary for the Vilex Trident™ Fusion Implant. This document is a premarket notification to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.

It does not contain information about acceptance criteria, device performance, or human study results. The document focuses on establishing substantial equivalence based on indications for use, material, sizes, shapes, and technological characteristics compared to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies with human participants, expert ground truth, sample sizes, or MRMC studies, as none of this information is present in the provided text.

The closest information to "device performance" is the statement repeated under "Technological Characteristics" and "Substantial Equivalence" that: "The technological characteristics for the Trident Fusion Implant are the same as the characteristics of the predicate devices." and "The design features of the Trident Fusion Implant are substantially equivalent to the design features of other predicate devices previously cleared for market." This implies that its performance is expected to be similar to legally marketed devices.

The document states that "The safety and effectiveness of the Trident Fusion Implant are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." However, the details of this "analysis data" proving safety and effectiveness are not included in the provided text.

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