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The Osteomed ExtremiFix Mini & Small Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

The OsteoMed Mini & Small Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:

2.0mm screw diameter - 6 mm to 42 mm screw length; 2.4mm screw diameter - 6 mm to 50 mm screw length; 3.0mm screw diameter - 10 mm to 40 mm screw length; 4.0mm screw diameter - 12 mm to 52 mm screw length;

The system instruments include depth gauges, screwdrivers, countersinks, guide wires, and other instruments to facilitate the placement of screws.

The implants (screws and washers) of the OsteoMed ExtremiFix Mini & Small Cannulated Screw System are made from titanium alloy (ASTM F136). Modifications to the screws include changing the screw drive connection from a trilobe to a hexalobe and adding a headed screw option for each of the screw size offerings (2.0, 2.4, 3.0, and 4.0 mm diameters). The screws and washers are intended for single use only.

The subject device's system instruments include k-wires, drills, countersinks, drivers, tissue protectors, and screw extractor. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymer. The k-wires, screw extractor, and drills are intended for single use only.

The provided text is a 510(k) summary for the OsteoMed ExtremiFix Mini & Small Cannulated Screw System. This document describes a medical device, specifically bone fixation fasteners, and its equivalence to a predicate device already on the market.

However, the questions posed (acceptance criteria, study details like sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training and test sets) are typically relevant for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices which involve complex algorithms, image analysis, or clinical decision support systems.

The OsteoMed ExtremiFix Mini & Small Cannulated Screw System is a physical medical device (screws and instruments). Its "performance data" refers to bench testing for mechanical strength and material properties to ensure it functions as intended and is equivalent to existing devices. Therefore, the detailed questions about AI/ML study methodologies, such as those concerning "ground truth," "expert consensus," "training set," "test set," "human-in-the-loop," "MRMC," and "effect size of human readers improving with AI" do not apply to this type of device.

The document explicitly states: "Clinical testing is not required to support substantial equivalence." This reinforces that the evaluation is based on mechanical and material properties compared to a predicate, not on a clinical AI/ML performance study.

Therefore, I cannot extract the requested information (acceptance criteria as per AI/ML studies, details of AI/ML study design, MRMC, training/test set specifics, etc.) from this document because it describes a traditional hardware medical device, not an AI/ML device.

The relevant "performance data" provided are:

• Type of Study: Bench testing.
• Purpose of Study: To ensure the design features met the required mechanical strength criteria for their intended use and to show performance equivalence to the predicate device (OsteoMed Headless Cannulated Screw System, K063298).
• Conclusion: The device "demonstrates the subject devices are as safe, as effective, and performs as well as the predicate device."

This document does not contain the information required to answer your specific questions related to AI/ML device validation.

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