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The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implant. It describes the device, its intended use, and its classification. However, it does not contain information about acceptance criteria for a study demonstrating device performance, nor details of a study that proves the device meets such criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Information on MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Information regarding the training set's size or how its ground truth was established.

The document primarily focuses on the regulatory aspects of the device, establishing substantial equivalence to a predicate device, and outlining general controls and FDA regulations. It mentions that there are "no technological differences to the material (PMMA) and no differences to the materials of manufacturing. There are no differences to the packaging or sterilization process" compared to its predicate device (Longeviti ClearFit OTS Cranial Implant, K212058). This suggests that the substantial equivalence determination is based on the similarity of the device to previously cleared devices, rather than new performance data from a specific study demonstrating new acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The text does not contain that information.

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The Longeviti ClearFit™ OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implants. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that a specific new device (such as an AI/ML powered device) meets acceptance criteria for classification tasks (e.g., detecting disease, segmenting organs).

Therefore, the document does not contain the information needed to answer questions 1-9 in the requested format, as those questions typically apply to studies evaluating the performance of AI/ML algorithms, especially in diagnostic or clinical decision support contexts.

The document discusses:

• Device Description: Off-the-shelf polymethyl methacrylate (PMMA) cranial implants.
• Intended Use: Correct and/or restore bony voids and/or defects of the cranium.
• Comparison to Predicate: The key difference highlighted is that the subject device is a fixed-size implant, while the predicate is a patient-specific implant. However, the document emphasizes that they use the same materials and manufacturing processes.
• Performance Testing: References several ASTM standards for tensile, flexural, and impact properties of plastics, stating that these tests were "passed" and are applicable due to similar materials and manufacturing.

It does not describe:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" in the sense of a clinical trial or algorithm performance evaluation using a test set of data with ground truth.
• Sample sizes for AI training or test sets.
• Expert involvement for ground truth establishment or MRMC studies.
• Any AI/ML components.

Therefore, it is impossible to populate the requested table and answer the study-related questions based on the provided text, as this document pertains to a physical medical device (cranial implant) and not an AI/ML powered device.

Ask a specific question about this device