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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.

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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.

Luxury Paraffin Bath

The provided text is a 510(k) premarket notification letter from the FDA regarding a paraffin bath device. It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and details. The document is solely a regulatory approval letter.

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The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses:

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

The Softique™ Paraffin Bath is a full-size paraffin bath with a paraffin wax capacity of five pounds (with a recommended use of three to four pounds of paratin wax), a melting time for the paraffin wax of approximately five hours, and a temperature range for the paraffin wax of 123-130°F. The unit utilizes two heaters with a total of 90 W in order to melt and maintain the temperature of the melted paraffin wax. The unit has an operation voltage of 120 V, 60 Hz. The Softique™ Paraffin Bath is supplied with a power cord, a plastic lid, three pounds of pure, hypo-allergenic paraffin wax, and 60 plastic liners.

This section is not applicable. The provided text is a 510(k) summary for a medical device (Softique™ Paraffin Bath) seeking substantial equivalence to predicate devices, not an AI/ML device that requires performance criteria based on a study. The document focuses on comparing the intended use, technological characteristics, and operating principles of the new device to existing ones rather than presenting a study to prove acceptance criteria through quantitative performance metrics.

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• Useful for 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 product covered by this 510(k) summary is a heated paraffin wax spa intended for home use. This product consists of a plastic enclosure, aluminum bucket and an internal heating assembly. The paraffin wax temperature is controlled by a variable electronic heat control with timing circuit. Temperature settings (low, medium, and high) and timing controls are displayed on a liquid crystal display. The product consumes 200 watts when plugged into a standard household electrical outlet supply of 120 Vac, 60 Hertz. The product comes in two different sizes.

The provided text describes a 510(k) premarket notification for the Remington Paraffin Spa, a heated paraffin wax spa. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics.

Therefore, many of the requested details, such as specific acceptance criteria, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, and standalone performance, are not available in the provided text. These types of studies are typically associated with performance evaluations of diagnostic devices or algorithms rather than a relatively simple therapeutic device like a paraffin bath seeking 510(k) clearance based on substantial equivalence.

Here's what can be extracted from the provided information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report a device's performance against such criteria. The basis for clearance is "substantial equivalence" to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set or data provenance is mentioned as this is a 510(k) submission based on substantial equivalence, not a clinical trial or performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment is described for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described.

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 is not an AI or diagnostic device; therefore, an MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The clearance is based on substantial equivalence to a predicate device and similar "principles of operation and technological characteristics."

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable.

Summary of Information Available from the Provided Text:

• Device Name: Remington® Paraffin Spa (Models HS-250 and PFS-600)
• Common Name: Paraffin Bath
• Intended Use:
  • 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.
• Classification: Class II, regulated under 21 C.F.R. § 890.5110 (Paraffin Bath).
• Predicate Device: ParaSpa™ Paraffin Bath by Homedics, Inc. (K001860).
• Substantial Equivalence Claim Reason: The Remington Paraffin Spa and the HoMedics ParaSpa™ Paraffin Bath have the same intended use and very similar principles of operation and technological characteristics. Minor technological differences do not raise new questions of safety or effectiveness.

The 510(k) clearance process, especially for devices like a paraffin bath, primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies involving test sets and expert ground truth establishment.

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