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The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite.

The Venus Freedom device, part of the Family of Venus RF devices, is a noninvasive, non-ablative device that delivers Radiofrequency (RF) energy, along with the Pulsed Electro-Magnetic Field (PEMF), into the skin to generate heat through electrical impedance in the epidermis, dermis, subcutaneous layers, and muscular tissue.
The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim).
The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.

Here's a breakdown of the acceptance criteria and study information for the Venus Freedom device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venus Heal, K182094), rather than setting specific quantifiable acceptance criteria against a defined clinical endpoint like accuracy (e.g., sensitivity, specificity for a diagnostic device). The performance data presented is focused on verification of technical specifications and safety.

• Max PEMF power density met. |
  | Safety - Temperature Control | - Bench test demonstrated the ability to maintain a safe treatment temperature on the surface of human skin using the same protocol as the predicate device, Venus Heal (K182094). |
  | Electrical Safety and Electromagnetic Compatibility (EMC) | - Complied with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-1-2. All results were "passing." |
  | Software Functionality | - Software verification and validation testing performed; device functioned as intended, and results were as expected. |
  | Biocompatibility | - Disposable tip materials tested per FDA Guidance and ISO 10993-1, 10993-5, 10993-10. Testing included cytotoxicity, sensitization, and irritation. All testing "passed." |
  | Clinical Effect (Equivalent to Predicate) | The Venus Freedom device is stated to be for the "Relief of minor muscle aches and pain, relief of muscle spasm, Temporary improvement of local blood circulation, Temporary reduction in the appearance of cellulite." The basis for this is substantial equivalence to the Venus Heal, which had these indications. No new clinical study data is presented to prove these effects for the Venus Freedom. |

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than conducting new, full-scale clinical trials to prove efficacy from scratch. Therefore, the "study" is primarily a set of verification and validation (V&V) tests designed to show that the new device (Venus Freedom) performs comparably to its predicate (Venus Heal) and meets essential safety and performance standards.

The key studies and tests performed are:

• Verification Tests: To ensure the device adheres to its technical specifications for RF power output and PEMF power density.
• Bench Test (Temperature Maintenance): This test specifically aimed to demonstrate the device's ability to maintain a safe treatment temperature on human skin. This was done using a protocol identical to that used for the predicate device, K182094 (Venus Heal).
• Electrical Safety and EMC Testing: Conformance to recognized international standards (IEC 60601 series).
• Software Verification and Validation: To ensure software functions as intended.
• Biocompatibility Testing: On new disposable tip materials, following ISO 10993 standards.

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

• Sample Size: The document does not specify a "sample size" in the context of human subjects or cases for a clinical test set. The performance data described are primarily bench tests and engineering verification tests. For the bench test on temperature, it's a simulation rather than a human subject study.
• Data Provenance: The data originates from internal testing conducted by Venus Concept (the manufacturer) as part of their device development and regulatory submission process. There is no mention of country of origin for data generation specifically, but the company is Venus Concept USA Inc. The tests are prospective in the sense that they were conducted specifically for the Venus Freedom device 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:

• This information is not applicable to the type of studies presented. The "ground truth" here is adherence to technical specifications, safety standards, and functional performance, which are assessed through engineering and bench testing, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving multiple readers for diagnostic or prognostic tasks to resolve disagreements. The reported studies are technical verification and validation, not clinical efficacy studies requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is a therapeutic electrosurgical device, not a diagnostic AI-assisted imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

• This is not applicable as the device is not an AI algorithm but a physical electrosurgical system. Its performance is inherent in its operation and effect on tissue, rather than an "algorithm-only" output.

7. The Type of Ground Truth Used:

• The "ground truth" used for the reported performance tests are:
  • Technical specifications: For RF power, PEMF power density.
  • Safety standards: For temperature maintenance and electrical/EMC performance (e.g., safe temperature limits, IEC standard compliance).
  • Biocompatibility standards: For material safety (ISO 10993 series).
  • Functional requirements: For software performance.

8. The Sample Size for the Training Set:

• This information is not applicable. The Venus Freedom device is not described as an AI/ML-driven device that requires a "training set" in the context of machine learning model development. The design and operation are based on established RF and PEMF physics and engineering principles.

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

• This is not applicable for the same reason as above (no AI/ML training involved).

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