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The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine; hand, tibia; radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

The SKy System consists of the following components:

• Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
• Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set - a set of accessories to assist in insertion and location of the device.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the SKy Bone Expander System, outlining its intended use, description, and substantial equivalence to previously cleared devices. It does not include details about performance testing, sample sizes, ground truth establishment, or clinical studies.

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The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components:

• Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced diameter configuration and expanded within the bone.
• Delivery System used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set a set of accessories to assist in insertion and location of the device.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. SKy Bone Expander System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study proving the device meets them, as that information is not present in the given input.

The document discusses:

• Company and Product Information: Name, contact, date prepared, trade/proprietary name, classification.
• Predicate Devices: Lists similar devices.
• Intended Use: Specifies the medical application of the device.
• System Description: Describes the components of the SKy System.
• Substantial Equivalence: Highlights similarities between the modified SKy System and its previously cleared version, and other predicate devices, focusing on operating principles, design, materials, packaging, and sterilization.
• FDA Correspondence: Official letter from the FDA confirming the substantial equivalence determination and allowing the device to be marketed.
• Indications for Use Form: A standard form reiterating the intended use.

None of these sections include data from performance studies, acceptance criteria, or details regarding ground truth, sample sizes, expert qualifications, or adjudication methods typically found in effectiveness or validation studies.

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