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When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.

The provided text describes a 510(k) premarket notification for a medical device called an "External Fixation Ring." This submission is for a new device claiming substantial equivalence to existing predicate devices. However, this submission does not include any information about acceptance criteria or a study proving device performance in the context of an AI/ML-driven medical device.

The document details:

• Device Name: External Fixation Ring
• Submitter: RIGID FX Orthopedics, Inc.
• Classification: Single/multiple component metallic bone fixation appliances and accessories (21 CFR section 888.3030)
• Description: Ring component of an external fixation device, made of two beryllium-aluminum alloy rings encased in injection-molded polycarbonate plastic.
• Intended Use: Stabilizes open and/or unstable fractures of long bones, joint fusions, and limb lengthening/deformity corrections.
• Technological Characteristics: Material (beryllium-aluminum alloy) differs from predicates (aluminum alloy or carbon fiber composite).
• Nonclinical Tests: "This device has similar load carrying capabilities as solid rings made of aluminum alloy." This is the only mention of performance testing, and it's a general statement, not a detailed study.
• Predicate Devices: Several external fixation systems are listed as equivalent devices.

Therefore, it is impossible to complete the requested table and answer the study-related questions as the provided input does not contain the necessary information. The submission mainly focuses on the device description, intended use, comparison to predicate devices, and a high-level statement about nonclinical testing for mechanical properties. There is no mention of an AI/ML component, acceptance criteria for an algorithm, or any study design/results related to software performance.

To answer the prompt, I would need a different type of document, specifically one that outlines a clinical or non-clinical study for an AI/ML-driven medical device, including its performance metrics and acceptance criteria.

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The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:

• fractures of the wrist with ligamentous instability .
• comminuted intra-articular radius fractures
• post-traumatic reconstruction for joint stiffness .
• Colles Fracture .
• distal radius fractures (Types B and C) .
• Frykman Type III, IV, VII and VIII radius fractures
• any wrist fracture requiring distraction

The device is a preassembled, mechanically adjustable external fixator and is available in three sizes (small, medium, and large). It is a four-piece construct consisting of a radiolucent polycarbonate plastic and applied to the bone with 2 pairs, with the option of a third pair, of self-drilling half-pins measuring 3mm x 110mm both cancellous and cortical. The half pins are used as bone anchors and are manufactured from medical grade stainless steel (316LVM).

The provided text is a 510(k) premarket notification for the ClearView™ Wrist Fixator, a medical device. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices already on the market.

However, the document does not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC studies or standalone performance).

Therefore, I cannot provide the requested table and information based on the given input. The 510(k) summary focuses on demonstrating substantial equivalence to already approved devices, which often relies on comparison of technical specifications and intended use rather than new clinical effectiveness studies with specific performance metrics and ground truth evaluations.

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