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HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation.

HEBE is a device indicated for radiofrequency (RF) treatments at 448kHz. This frequency is associated with pain reduction and improved functionality in patients with musculoskeletal disorders. This wavelength promotes ion mobilization between the intracellular and extracellular matrix and restores cell membrane permeability. The energy generated at 448 kHz improves cell membrane permeability, enhancing intracellular and extracellular exchange and tissue regeneration. Furthermore, high-intensity radiofrequency treatment at 448 kHz can induce significant hyperthermia, which can lead to a considerable increase in cell metabolism and accelerated recovery. These hyperthermal adaptations to radiofrequency treatment are based on vasodilatation, causing a targeted local increase of blood perfusion and decreases in muscle tension and spasm, increased oxygen and nutrient supply, and healing acceleration.
RF treatment can be applied through either capacitive or resistive electrodes that pass radiofrequency to the human body.
HEBE has 3 different technologies:

• Monopolar Capacitive Radiofrequency
• Monopolar Resistive Radiofrequency
• Bipolar Resistive Radiofrequency

The provided FDA 510(k) clearance letter and summary for the HEBE device primarily focus on substantial equivalence to predicate devices through comparisons of features and performance specifications. It does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on clinical outcomes or a rigorous statistical evaluation of its effectiveness.

The document highlights bench testing and compliance with safety and electrical standards (IEC 60601 series, IEC 62304) and biocompatibility standards (ISO 10993 series). This indicates the device's safety and fundamental operational aspects were verified, but not its clinical efficacy against pre-defined performance metrics in a clinical setting.

Therefore, many of the specific questions about acceptance criteria and clinical study details cannot be answered from the provided text, as the application relies on substantial equivalence and non-clinical performance data, rather than a direct clinical performance study with acceptance criteria for clinical outcomes.

Here's an attempt to answer the questions based only on the provided information, noting where information is absent:

Acceptance Criteria and Device Performance (Based on Provided Data)

The concept of "acceptance criteria" for clinical performance is not explicitly defined or measured in this document. Instead, the "performance specifications" are a comparison to predicate devices, indicating similarity rather than a proven threshold for efficacy.

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

Based on the provided information, there are no clinically-defined acceptance criteria with corresponding device performance data for efficacy. The "performance specifications" listed are comparative to the predicate and reference devices regarding technical parameters.

Note on "Acceptance Criteria" for Performance Features: For a 510(k) submission based on substantial equivalence, the "acceptance criteria" for these technical performance specifications is typically that they are "the Same" or "Equivalent" to the predicate device(s) without raising new questions of safety or effectiveness. The document asserts that the HEBE device meets this implicitly by stating "Same" or providing values within a comparable range.

Study Details (Based on Provided Data)

The document does not describe a clinical study that proves the device meets specific acceptance criteria for clinical outcomes (e.g., pain relief, muscle spasm reduction). The performance data cited are related to bench testing for safety, electrical, and biocompatibility standards, and a comparison of technical specifications to predicate devices.

Therefore, for most of the following questions, the answer will be that the information is not provided in the clearance letter.

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

• Not provided. The document describes "Verification and validation were performed on the device using the established methods by using the predicate device" and lists standards for safety and electrical performance. This refers to bench testing, not a clinical human test set.

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 clinical test set with human data requiring expert ground truth establishment is described. The "experts" would be engineers and testers performing bench tests.

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

• Not applicable. No clinical test set requiring adjudication 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 device is an electrosurgical cutting and coagulation device for topical heating, not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study.

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

• Not applicable. This is a physical medical device (radiofrequency treatment), not an algorithm with standalone performance. Its "performance" relates to its physical output and safety.

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

• For the bench testing: The "ground truth" would be the specifications and requirements defined by the IEC and ISO standards (e.g., electrical safety limits, biocompatibility thresholds, specified temperature output).
• For clinical efficacy: This information is not provided. The 510(k) relies on substantial equivalence and the known mechanism of action of similar devices for its intended use, rather than presenting new clinical outcomes data.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would have a "training set" in the conventional sense. The "training" for such devices is their design and manufacturing to meet the specified performance and safety standards.

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

• Not applicable. (See point 8.)

Summary of what the document does provide:

The 510(k) summary focuses heavily on:

• Substantial Equivalence: Comparing the HEBE device's features, indications for use, principle of action, and technical specifications (frequency, power) to a primary predicate device (NuEra Tight RF Family) and a reference device (Deep Care). The conclusion is that it is "safe and effective and are substantially equivalent."
• Bench Testing & Standard Compliance: The device underwent verification and validation tests in accordance with a range of established international standards for medical electrical equipment (IEC 60601 series, IEC 62304) and biocompatibility (ISO 10993 series). These tests verify the device's electrical safety, usability, electromagnetic compatibility, and material safety.

This type of submission is common for Class II devices where a new device is similar enough to existing legally marketed devices that extensive new clinical trials demonstrating efficacy are not required, provided new questions of safety or effectiveness are not raised.

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