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The Vari-Angle Hip Screw is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.

The Vari-Angle Hip Screw System is a compression hip fixation system used for the treatment of femoral neck fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.

The provided text is a 510(k) summary for the Vari-Angle Hip Screw System, a medical device used for treating femoral neck fractures. This type of submission to the FDA focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a detailed clinical study with acceptance criteria and performance data in the way one would for a novel algorithm or diagnostic device.

Therefore, the specific information requested in the prompt (acceptance criteria, detailed study design, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not present in this document. The 510(k) process for this device type primarily relies on demonstrating material and design similarity to already approved devices.

Here's a breakdown of why the requested information isn't available in this document:

• Acceptance Criteria & Device Performance Table: This document does not describe specific numerical performance metrics or acceptance criteria for the Vari-Angle Hip Screw System. Instead, it asserts "no significant differences" in technological characteristics compared to predicate devices.
• Sample Size (Test Set) & Data Provenance: There is no mention of a test set, clinical data, or sample sizes for performance evaluation.
• Number of Experts & Qualifications: Not applicable, as no expert-adjudicated ground truth study is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: This is not a diagnostic device involving human readers or AI. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant and not mentioned.
• Standalone Performance: This is a physical implant, not an algorithm. "Standalone performance" in the context of an algorithm's output does not apply here. The device's function is mechanical and biologically integrated.
• Type of Ground Truth Used: Not applicable, as detailed performance measurement against a ground truth is not the basis of this 510(k) submission.
• Sample Size for Training Set: Not applicable. There is no algorithm or "training set" in the context of this mechanical device.
• How Ground Truth for Training Set was Established: Not applicable.

Instead, the document focuses on:

• Substantial Equivalence: The core of this 510(k) is to prove that the Vari-Angle Hip Screw System is "substantially equivalent" to legally marketed predicate devices (e.g., Free-Lock Compression Hip Fixation System, AMBI Hip Screw System). This means comparing design, function, material, and intended use.
• Predicate Devices: A list of predicate devices is provided.
• Materials: Stated as 316 LVM stainless steel per ASTM standards.
• Function: To provide immediate stability and temporary fixation during healing of femoral neck fractures.
• Intended Use: Specifically listed for various types of femoral fractures and osteotomies.

Conclusion:

The provided 510(k) summary for the Vari-Angle Hip Screw System does not contain information related to acceptance criteria, detailed study designs, sample sizes, expert ground truth, or AI-related performance metrics as requested. This is because it's a submission for a mechanical implant based on substantial equivalence, not a diagnostic device or algorithm requiring such detailed performance study data.

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