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The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that care common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatassi, fibular shaft, malleolus fractures where indicated, The DRG Medium Screw™ System is indicated for:

Humeral Shaft Distal and proximal humerus Distal and proximal radius and ulna Radial and ulna shaft

Distal tibia and ankle Talus-calcaneus-matatarsal Fibular shaft and Malleolus fractures Intermediate Bone Fractures

The Dolphin Medical Technologies DRG Medium Screw™ System will be offered in Ti-6A1-V ELI. It will be available in common styles and assorted lengths for bone fixation and stabilization. A range of twenty six screw lengths will be made available in 4.5 mm diameter (16-72 mm) with four different distal thread length dimension (6.5mm, 16mm, 26mm). The screws are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated, on center axis.

The provided document is a 510(k) premarket notification for a medical device (DRG Medium Screw™ System), which focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size) are not applicable in the context of this document.

Explanation:

• 510(k) Premarket Notification: This regulatory pathway is used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and technological characteristics, and showing that the new device raises no new questions of safety or effectiveness. It does not inherently require a clinical study with predefined acceptance criteria for device performance in the same way a PMA (Premarket Approval) or De Novo application might.
• Performance Standards: The document explicitly states: "No performance standards applicable to the Bone Screw have been established by the FDA." Instead, it relies on meeting voluntary material standards (ASTM F136-84) and demonstrating equivalence to existing devices.
• Substantial Equivalence: The primary "proof" in this document is the comparison to a list of existing, approved bone screws (e.g., Ace Medical Company K903810, Osteomed K924018). The study that "proves" the device meets acceptance criteria is implicitly the comparison against these predicate devices based on their known design, materials, and clinical history.

In summary, the document addresses substantial equivalence, not performance acceptance criteria through a dedicated study.

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The Dolphin Medical Technologies DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The indications for use of the DRG Large Screw™ System reconstruction of intra-anicular epiphyseal and of metaphyseal fractures. Specifically, intracapsular fractures of the hip, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures, ankle, elbow and shoulder fractures where indicated.

The DMT DRG Large Screw™ System will be offered in Ti-GAL-4V ELL It will be available in common styles and assorted lengths for bone fraction and stabilization. Initially, a range of twenty-four screw lengths will be made available in 6.5 mm diameter (25-120 mm). Screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwcriver, which is cannulated at center.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) submission for the DRG Large Screw™ System, focusing on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance study data against defined acceptance criteria.

The document mentions:

• Performance Standards: "No performance standards applicable to the Bone Screw have been established by the FDA."
• Material Standards: The titanium alloy used meets ASTM F136-84, and the general material and design meet ASTM B348-83, F136-84, F67. This refers to material specifications, not device performance criteria in a clinical or mechanical test context.
• Substantial Equivalence: The core of the submission is asserting that the product is "substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market" and lists several predicate devices.

Therefore, I cannot extract the specific details you requested because they are not present in the provided text.

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