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The RF-Relief is an over the counter hand held device intended to emit energy in RF spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The RF-Relief is an OTC, home use device, designed to deliver RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a non-invasive, non-ablative device and it is supplied as non-sterile.

The RF-Relief device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes four Bi-polar (2 pairs) electrodes, two redundant temperature sensors and a vibration motor. The PLC (on the PCBA) is especially configured software combined with hardware circuits that provides the operational and safety function of the system.

The RF-Relief device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the RF energy together with mechanical massage over the entire treatment area.

The RF-Relief device is an over-the-counter handheld device intended to emit radio frequency (RF) energy for topical heating to temporarily relieve minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasms, temporarily increase local blood circulation, and temporarily relax muscles.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document describes various bench tests, verification and validation (V&V) activities, and other performance studies. However, specific numerical sample sizes for each of these test sets are generally not provided.

• Bench Tests (Overheating safety, Power accuracy, Parameter validation): These tests typically involve multiple measurements and iterations but the exact number of units or repetitions is not specified.
• Electrical Safety and EMC testing: Performed according to recognized standards (IEC 60601 family), which specify testing methodologies but not necessarily sample sizes in this summary.
• Software Verification and Validation: Verification and validation testing was conducted, but the sample size (e.g., number of test cases or iterations) for this is not explicitly stated.
• Performance testing - temperature during treatment: The study measured "temperature measurement of the skin during treatment," but the number of subjects or test runs is not specified. It states "all skin types," implying a range of conditions were tested.
• Labeling comprehension/Self-Selection study: A study "Demonstrated that intended OTC users can understand the package labeling." No sample size for users is given.
• Usability/User Interface study: "Evaluated usability performance for intended use." No sample size for users is given.
• Biocompatibility: The biocompatibility evaluation was conducted based on the identical materials of the predicate device. It's not a study with a sample size for the RF-Relief itself, but rather a compliance assessment based on the predicate.

Data Provenance: The studies are primarily described as non-clinical (bench) performance data conducted by EL Global Trade Ltd., presumably in Israel (where the company is based). The Labeling comprehension/Self-Selection study and Usability/User interface study would have involved human subjects, but their geographical origin is not specified, though likely related to the company's location or target market. All data are prospective tests performed to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• No information is provided regarding the number of experts or their qualifications for establishing ground truth for any of the described test sets.
• For bench and V&V tests, ground truth is typically established by engineering specifications and recognized international standards.
• For the labeling comprehension and usability studies, "ground truth" would be determined by the study design (e.g., whether users correctly understood labels or successfully operated the device), not by expert consensus in the traditional sense.

4. Adjudication Method

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned for any of the described studies.
• For quantitative bench tests, acceptance is usually based on pre-defined numerical thresholds.
• For qualitative studies like usability or labeling comprehension, acceptance would be based on predefined success rates or other qualitative metrics, not typically requiring expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data is included in this submission."
• Therefore, there is no information on human reader improvement with or without AI assistance as this device is not an AI/imaging diagnostic tool, and no clinical studies were performed.

6. Standalone Performance Study

• Standalone performance studies were conducted in the form of bench testing and verification/validation (V&V) activities. These studies assess the device's inherent performance characteristics (e.g., power accuracy, temperature control, parameter validation, electrical safety) independently of human operation nuances, though a "human-in-the-loop" aspect exists for the usability and labeling comprehension studies.
• The "Performance testing - temperature during treatment" also evaluated the device's standalone ability to reach and maintain a safe and effective temperature on skin, indicating its core functional performance.

7. Type of Ground Truth Used

• Bench Tests (Overheating safety, Power accuracy, Parameter validation, Electrical Safety and EMC): The ground truth relies on engineering specifications, international standards (e.g., IEC 60601 family), and established scientific principles (e.g., human skin pain/burn thresholds from NIST).
• Software Verification and Validation: Ground truth is against the software requirements specification and design documents.
• Performance testing - temperature during treatment: Ground truth for "safe and effective temperature" is based on published medical/scientific information (e.g., National Institute for Standard and Technology reference) and the device's intended use.
• Labeling Comprehension/Self-Selection and Usability/User Interface: Ground truth for these studies would be based on the correctness of user responses/actions against predefined criteria for understanding and usability.
• Biocompatibility: Ground truth is compliance with international standards (ISO 10993) and the previously cleared predicate device.

8. Sample Size for the Training Set

• The document does not describe the use of any AI/ML components that would require a "training set." All described tests are for a hardware device with embedded software.
• Therefore, the concept of a training set for an algorithm is not applicable here.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned or applicable to this device submission, this information is not provided.

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