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The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

This is a 510(k) summary for a medical device called "Ultima HA Coated Half Pins & Wires". The purpose of this summary is to demonstrate substantial equivalence to existing predicate devices, not to prove performance against specific acceptance criteria in a clinical study. Therefore, the information requested regarding acceptance criteria and study details is not present in this document.

Here's a breakdown of why the requested information cannot be provided from the given text:

• This is a 510(k) submission: 510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with specific performance metrics and acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." This means the assessment is based on comparisons with existing devices, not a standalone performance study.
• No mention of a clinical study for acceptance criteria: There is no description of a study designed to measure the device's performance against specific acceptance criteria. The "analysis data" mentioned likely refers to bench testing and material characterization, not patient data.

Therefore, I cannot provide the requested information for the following reasons:

1. A table of acceptance criteria and the reported device performance: Not present. The device is being cleared based on substantial equivalence, not a direct performance test against pre-defined criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment activity from a clinical study is described.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a bone fixation fastener, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document concludes that "any differences that may exist do not significantly affect device safety and effectiveness" and that the device is "substantially equivalent to the predicate devices." This is the primary "proof" for a 510(k) submission of this nature.

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