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510(k) Data Aggregation
(109 days)
The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.
This document is a 510(k) Summary for the Venus Viva SR Device, indicating that it has been determined to be substantially equivalent to a predicate device. As such, it does not contain the detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way one might expect for a novel device or a clinical trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.
However, I can extract information related to performance evaluations and the animal study that supports the device's safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome. Instead, it describes various tests and their "passing" or "as expected" results, demonstrating compliance with recognized standards and expected performance in a pre-clinical setting.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) & Electrical Safety | All results were "passing" per AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Biocompatibility | Patient contacting materials (ASTM F899-12b stainless steel, plastic) are biocompatible. |
| Sterilization | Demonstrated that the sterilization cycle achieved a sterility assurance level of 10-6 per ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11138-1, and AAMI/ANSI ST79. |
| Software Validation | Results demonstrated that the software was "appropriate for release." |
| Bench Testing (Radiofrequency Outputs) | Outputs are "substantially equivalent" to those of the predicate device. |
| Animal Study (In Vivo & Gross Necropsy - Erythema, Edema, Microneedle Pattern) | Results were "as expected" at Day 0, Day 4, and Day 14. |
| Animal Study (Histopathology - Healing Profile) | Skin biopsies showed "skin that was healing well." |
| Animal Study (Overall Safety & Performance) | Exhibited a "favorable safety profile and performed as intended in daily observations, adverse events, gross necropsy, wound assessment, and histopathology." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions a "porcine study" (animal study). The specific number of animals or treatment sites is not specified.
- Data Provenance: The study was an animal study (porcine), which is a pre-clinical setting. The country of origin is not specified. It is implicitly a prospective study in the context of controlled experimental animal research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document states "Skin biopsies were submitted for pathologic review to assess the healing profile at sites following treatment."
- Number of experts: Not specified.
- Qualifications of experts: The experts are implicitly pathologists, but their specific qualifications (e.g., years of experience) are not detailed.
4. Adjudication method for the test set
- The document mentions "gross necropsy findings" and "pathologic review." It does not specify an explicit adjudication method like "2+1" or "3+1" for interpreting these findings. It implies a standard pathological review process.
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
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (Venus Viva SR Device) for dermatological procedures, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The Venus Viva SR Device is an energy-based medical device, not an algorithm. The performance evaluation focuses on the device's physical and biological effects, not on an algorithm's diagnostic accuracy.
7. The type of ground truth used
- For the animal study:
- Direct observation: For erythema, edema, and microneedle pattern at specified time points (Day 0, Day 4, Day 14).
- Histopathology: For assessing the healing profile of skin biopsies.
- Gross necropsy: For evaluating overall findings.
8. The sample size for the training set
- This document describes a 510(k) submission for a medical device, not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The device's design and parameters are based on engineering principles and comparisons to predicate devices, not on training data.
9. How the ground truth for the training set was established
- As there is no "training set" for this type of device, this question is not applicable.
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