Search Results

The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is:

• Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
• Relaxes muscles, relieves stiffness and muscle spasm
• Stimulates circulation and for other conditions where heat is indicated.

The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is an 80 Watt paraffin bath unit, with a thermostat that varies the heat from High to Keep Warm. There are two LEDs, a red LED for the heater, and a green LED to indicate the power. The unit is provided with 3lbs of paraffin wax, a plastic mat when dipping the hands or feet, glove liners, and a pair of mitts.

This document is a 510(k) summary for a Paraffin Bath device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it details the substantial equivalence to a predicate device based on safety and performance testing for a physical medical device.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria in terms of performance metrics like sensitivity, specificity, or AUC for an AI/ML device.
• A study proving the device meets such acceptance criteria.
• Sample sizes for test sets (beyond an implication of comparing two physical units).
• Data provenance for AI/ML development.
• Number of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies to compare human readers with and without AI.
• Standalone algorithm performance.
• Ground truth type in the context of AI/ML (e.g., pathology, outcomes data).
• Training set sample size or ground truth establishment for a training set.

The document focuses on:

• Safety Testing: Compliance with UL1431 and CAN/CSA C22.2 No. 64-M91 standards for electrical and health care appliances.
• Performance Testing: A comparison of the time required to melt wax between the new device and the predicate device, noting the difference was expected due to power consumption differences.
• Substantial Equivalence: The key argument for approval is that the new device is as safe and effective as a previously cleared predicate device, with similar indications for use, design, and function, and that technological differences do not raise new safety or effectiveness concerns.

Ask a specific question about this device