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The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.

The Precimed Cannulated Screw System is a Cannulated Screw System used for the fixation of bone fractures and for bone reconstructions. It consists of multiple sizes of cannulated screws in varying diameters and lengths. Materials: The devices are manufactured from 316 LVM stainless steel per ASTM and ISO standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures.

The provided text is a 510(k) summary for the Precimed Cannulated Screw System, which is a medical device for bone fixation. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to software or AI performance.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. In the context of medical devices, especially for mechanical devices like screws, substantial equivalence often relies on demonstrating similar design, materials, function, and intended use, rather than a performance study with specific acceptance criteria that would typically be found for algorithms or AI.

Therefore, I cannot provide the requested information from the given text because it does not exist within the provided document. The document describes a traditional 510(k) pathway for a physical medical device.

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The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.

The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.

I am sorry, but the provided text only contains an FDA 510(k) summary for the "Precimed Hip Screw System" and related correspondence. This type of document is for a medical device (an implantable screw system), not an AI or software-based device that would have performance acceptance criteria, a test set, expert ground truth, or an MRMC study.

Therefore, I cannot extract the information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods as these are not relevant to this type of device and are not present in the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

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