Search Results

The SimpliFix Hip System is intended for fracture fixation of large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.

The SimpliFix Hip System is designed for angular and rotational stability when used for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to DHS in basilar neck fractures.

The system is comprised of Cannulated and Cross Screws that are used together to aid fracture fixation.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter for a medical device called the "SimpliFix Hip System."

The document focuses on:

• The FDA's determination of substantial equivalence for the SimpliFix Hip System to legally marketed predicate devices.
• The intended uses (indications for use) of the device.
• A brief device description.
• A summary of performance testing conducted (dynamic screw construct testing, screw performance testing per ASTM F543 and F1264, pyrogenicity testing). This is mechanical performance testing, not clinical/AI model performance.
• Regulatory information about FDA requirements.

There is no mention of:

• Any AI/algorithm component of the device.
• Clinical study data related to acceptance criteria for an AI model.
• Sample sizes for test or training sets for an AI model.
• Expert involvement for ground truth or adjudication methods for AI.
• MRMC studies for AI.
• Stand-alone AI performance.

Therefore, I cannot provide a table of acceptance criteria and device performance for an AI model, nor can I answer the specific questions about the study that proves an AI device meets acceptance criteria, as the document does not relate to an AI device.

Ask a specific question about this device

The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of cannulated, solid titanium allov. headless, headed screws and specialized instrumentation. This submission expands the Healix offering and includes longer screws ranging from 31 to 130mm in length for the 2.0 to 7.5mm diameters.

The provided text is a 510(k) summary for the Nvision Biomedical Technologies' Healix Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance.

Instead, this document is a regulatory submission for a physical medical device (bone fixation screws) and relies on mechanical performance characteristics and a comparison to existing predicate devices.

Therefore, I cannot extract the requested information (items 1-9) as it pertains to AI/ML device performance from the provided text. The document clearly states:

• "No FDA performance standards have been established for the Healix Compression Screw System."
• "The following was performed to demonstrate safety per methods of the previous submission: . Engineering analysis comparison of mechanical performance characteristics"
• "The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices."

This indicates the evaluation was based on engineering analysis and comparison against physical predicate devices, not on a study proving a device meets acceptance criteria related to diagnostic performance, human-in-the-loop improvements, or ground truth establishment for AI/ML.

Ask a specific question about this device