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The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

The Biofusionary Bebe is used for diathermic heating of tissue. The Biofusionary Bebe hand piece tip is comprised of a coil shaped antenna which directs the flow of current parallel to the tissue surface, without contacting the tissue surface, thereby directing the magnetic component of the electromagnetic energy into tissue to result in the formation of eddy currents in tissue. These eddy currents encounter resistance, leading to localized heating.

This 510(k) premarket notification describes the Biofusionary Bebe System, a shortwave diathermy device intended for generating deep heat within body tissues to treat conditions like pain, muscle spasms, and joint contractures. The submission primarily focuses on establishing substantial equivalence to a predicate device (Chattanooga Group-Intelect SWD 100, K083433) rather than a standalone clinical study for therapeutic effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, to the extent provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't present a formalized table of acceptance criteria with specific quantitative targets for clinical outcomes. Instead, it relies on demonstrating that the device meets product specifications and performs comparably to the predicate device in terms of heating capabilities and safety.

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

• Heating Characterization Studies (Benchtop): Phantoms and ex vivo porcine skin tissue were used. No specific sample sizes for these tests are provided.
• In Vivo Studies: "in vivo studies on rats" were conducted. No specific sample size is provided.
• Clinical Studies: "two clinical studies completed to further determine feasibility and safety and effectiveness." No specific sample size is provided for these. The document states they were "feasibility and safety and effectiveness" studies, implying they might not be large-scale effectiveness trials.
• Usability Study: "naive users were first instructed to review the User Manual and protocols for use of the device, followed by actual use of the device in a mock setting." No specific sample size for users is provided.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the description of "clinical studies," they were likely prospective.

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

Not applicable for this type of device and submission. The "ground truth" for heating capabilities was derived from instrument measurements (temperature probes in phantoms/tissue). For usability, direct observation and questioning of users served as the assessment method. For safety, compliance with engineering standards (IEEE 95.1-2005) was the basis.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements (temperature, electromagnetic field levels) or direct observation/feedback in the usability study, rather than expert adjudication of interpretations.

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 a shortwave diathermy system, a therapeutic medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is not an AI algorithm. It's a hardware-based therapeutic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Heating Capabilities: Measured temperature readings within phantoms and ex vivo porcine tissue. This is an objective, instrument-based "ground truth."
• Usability: User feedback and direct observation of user interaction with the device and manual.
• Safety: Compliance with established engineering and safety standards (e.g., IEEE 95.1-2005).
• Clinical Studies (Feasibility, Safety, Effectiveness): The document does not explicitly detail the ground truth or endpoints for the "two clinical studies." However, for diathermy devices, effectiveness would typically be gauged by physiological measurements (e.g., actual tissue temperature increases in vivo) and potentially patient-reported outcomes for pain relief or improved function, monitored for safety endpoints like adverse events. The document only states they were "to further determine feasibility and safety and effectiveness."

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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