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The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.

The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316LVM, ISO 5831-1/9.

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) premarket notification summary and a clearance letter for the "FEP and Stylo" external fixation systems. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, design, and materials, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information from the given text.

To address your request, the document would need to include sections detailing:

• Specific performance objectives for the device (e.g., strength, durability, biocompatibility).
• Test methods used to evaluate these objectives.
• Results of such tests compared against predefined acceptance criteria.
• Details about any clinical or technical studies conducted (sample sizes, ground truth establishment, expert qualifications, etc.).

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The intended use of the external fixation device is the same as that expressed in the predicate device 510k.

The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.

This is a 510(k) premarket notification for an external fixator device, which is a hardware device. The provided text is a regulatory submission for a medical device and does not contain information about software algorithms, AI, or performance studies in the context of digital health or AI/ML-enabled devices. Therefore, I cannot extract the requested information.

Here's why:

• Device Type: The document describes an "External Fixator," which is a physical, mechanical medical device used for orthopedic conditions. It is not a software device or an AI/ML system.
• Approval Process: The 510(k) summary explicitly focuses on demonstrating substantial equivalence to a predicate device (another external fixator) based on similar design characteristics and intended use. This is a common pathway for traditional medical devices.
• Missing Information: The document does not discuss:
  • Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
  • Any study involving a "test set," "training set," "ground truth," "experts," "adjudication," or "human readers."
  • "Multi reader multi case (MRMC) comparative effectiveness study" or "standalone performance."

In summary, the provided text is for a physical medical device and does not contain the kind of information requested about AI device performance studies.

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