(341 days)
Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.
Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.
The provided text describes the Meticuly Patient-Specific Titanium Mesh Implant and its substantial equivalence determination by the FDA. However, it does not contain the specific information requested regarding an AI/ML powered device, specifically:
- It does not describe acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or F1-score, which are typical for AI/ML devices.
- It does not specify sample sizes for test or training sets in terms of patient numbers or image counts, nor data provenance (country of origin, retrospective/prospective).
- It does not mention the number or qualifications of experts used for ground truth, any adjudication methods, or MRMC comparative effectiveness studies.
- It does not refer to standalone performance for an algorithm or the type of ground truth (e.g., pathology, outcomes data).
Instead, the document details the performance testing for a physical medical device (a patient-specific titanium mesh implant). The performance tests focus on material properties, manufacturing quality, biocompatibility, sterilization, packaging, and mechanical properties. The "comparative device modeling with Finite Element Analysis (FEA)", "comparative mechanical testing with modified compression test", and "comparative roughness testing" are all hardware-related validation activities, not AI/ML algorithm validation.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study details for an AI-powered device based on the provided text, as the text describes a physical implant and its regulatory submission, not an AI/ML device.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).