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Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin

Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.

The provided text is a 510(k) summary and FDA clearance letter for the "Uni-Patch Ultrasound Coupling Gel." This document focuses on the regulatory clearance process for a medical device (ultrasound gel) based on substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not available in the provided text. The document states:

• "Performance FDA has not established special controls or performance standards for this device"
• "Uni-Patch Ultrasound Coupling Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency."

This indicates that the clearance was based on demonstrating similarity to existing, legally marketed ultrasound gels, not on a new, controlled performance study with the metrics you've outlined for AI/diagnostic devices.

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The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring.

The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only.

The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.

Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

This document (K012218) is an FDA 510(k) clearance letter for the Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about specific acceptance criteria or details of a study (clinical or otherwise) that proves the device meets such criteria.

The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and classification. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information about multi-reader multi-case comparative effectiveness studies, standalone algorithm performance, or ground truth types.
• Details on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for these specifics based solely on the provided document. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which may involve referencing performance data or design specifications of the predicate, but the details of such assessments are typically found in the full 510(k) submission, not in the clearance letter itself.

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