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The Elemé Medical SMOOTHSHAPES XV system 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 XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.

Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).

The provided text is a 510(k) summary for the SMOOTHSHAPES® XV System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information about acceptance criteria or a specific study that proves the device meets those criteria, as requested in your prompt.

Specifically, the document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices (Elemé SmoothShapes (K083629) and Syneron Velashape (K071872)) for the indications of use. It does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or the number and qualifications of experts for ground truth.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• Specifics about the type of ground truth used or the size and ground truth establishment for a training set.

The document mostly outlines the administrative and regulatory aspects of the device's clearance.

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The Elemé Medical SmoothShapes® system 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 featuring Photomology® technology is designed to offer an innovative way to safely and effectively treat cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to reduce the appearance of cellulite.

The provided text is a 510(k) summary for the Elemé Medical SmoothShapes® System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, study details, or performance data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or specific study types like MRMC or standalone performance. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical study demonstrating meeting specific performance criteria.

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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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The Biocellulase SmoothShapes device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local hlood 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, and the key-switch. 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.

The provided text is a 510(k) Summary for the Biocellulase SmoothShapes device, which is a regulatory submission to the FDA. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance rather than presenting a detailed clinical study for novel performance claims or acceptance criteria in the way a clinical trial report would.

Therefore, much of the requested information regarding detailed acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, and ground truth methodologies is not explicitly available in this summary. The submission relies on demonstrating similarity to already approved devices.

Here's an analysis based on the provided text:

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

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

• Not explicitly available. The submission highlights "nonclinical testing" (electrical safety and tissue block testing). These are typically bench tests or in vitro studies, not clinical trials with human subjects for efficacy. The text does not describe any clinical test set or data provenance in the context of device performance for its intended use.

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 explicitly available. Since no clinical test set for efficacy is described, there's no mention of experts establishing ground truth for such a set. For the nonclinical testing, the "experts" would likely be engineers or technicians performing the safety tests, but their qualifications are not detailed.

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

• Not applicable/Not explicitly available. 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 a therapeutic device (massager/shaper with light-induced heating), not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.

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

• Not applicable. This device is a physical therapeutic device with specific mechanisms of action, not a software algorithm.

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

• For the nonclinical testing: The ground truth for electrical safety would be adherence to relevant electrical safety standards. For tissue block testing, the ground truth would be the measured temperature and its comparison to accepted safety thresholds.
• For the intended use claims: The submission relies on substantial equivalence to predicate devices that presumably had established their efficacy through clinical data or historical use. The device itself does not present new clinical data that would require "ground truth" to be established for novelty.

8. The sample size for the training set:

• Not applicable/Not explicitly available. Since no clinical study for efficacy is described in the summary, there is no mention of a training set for machine learning or similar applications.

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

• Not applicable/Not explicitly available. For the reasons mentioned above.

In summary:

This 510(k) submission is a "summary of safety and effectiveness" for a physical device seeking clearance based on substantial equivalence to legally marketed predicate devices. It focuses on comparing technological characteristics and intended use, along with basic non-clinical safety testing. It does not contain the details of a clinical efficacy study with human subjects, which would typically include acceptance criteria defined by performance metrics, detailed sample sizes, expert involvement, and ground truth establishment methods for clinical outcomes.

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