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The Biocellulase SmoothShapes device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The SmoothShapes system consists of a main console unit and an applied part (massage head with rollers) which is connected to the main console by an umbilical. The main console unit contains the powersupply, hardware, transformers, fuses, cooling fan, mains-input connection, software controls and user interface. The massage head, which is placed against the patient's skin, contains the rollers, LEDs, and laser diodes. The massage head rollers are mobilized in rotation and sliding back and forth. The patient massage is generated by the vacuum introduced to skin fold between the two rollers. The rollers in combination with the vacuum manipulate and smooth out the skin which facilitates tissue mobilization. The laser light provides topical heating which increases tissue temperature.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) Pre-market Notification for the Biocellulase SmoothShapes device, seeking substantial equivalence to legally marketed predicate devices.

The document discusses:

• Sponsor and Device Name: Biocellulase, Inc. - SmoothShapes
• Predicate Devices: Biocellulase SmoothShapes K053611 and Syneron Medical, Ltd. - VelaSmooth Shaper K050397
• Device Description: A system with a main console and an applied part (massage head with rollers, LEDs, and laser diodes) that uses vacuum, massage, and laser light.
• Intended Use: Relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
• Nonclinical Testing: Software Validation, electrical safety testing, and tissue block testing (to confirm maximal skin temperature rise).
• Conclusion: Based on technological characteristics and nonclinical testing, the device is considered as safe and effective as the predicate devices.
• FDA Premarket Notification Letter: Confirming the substantial equivalence determination for the stated indications.

The document explicitly states "Nonclinical Testing" and refers to "Software Validation, electrical safety testing and tissue block testing (to confirm maximal skin temperature rise)" but does not present any clinical study data, acceptance criteria, or performance measures against such criteria for its intended uses (e.g., reduction in appearance of cellulite, muscle pain relief).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as this information is not present in the provided text.

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