(84 days)
The Visage Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general dermatology, cosmetic, plastic, and reconstructive surgery including:
- Abscesses
- Aponeurotic Repair
- Basal Cell Carcinoma
- Biopsy
- Blepharoplasty
- Cosmetic Repairs
- Cysts
- Epithelioma
- Keratosis
- Mammaplasty
- Nevi (Moles)
- Oculoplastic Procedures
- Panniculectomy
- Papilloma Keloids
- Pedicle Flap
- Rhytidectomy
- Development of Skin Flaps
- Skin Tags
- Skin Resurfacing for Treatment of Wrinkles, Rhytides, and Furrows
- Verrucae (Warts)
The Visage Wands are bipolar, high frequency electrosurgical devices designed for general dermatological, cosmetic, plastic, and reconstructive procedures.
This 510(k) summary for the ArthroCare Visage® Wands does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a modern regulatory submission for AI/ML-based medical devices.
The document is for an electrosurgical device cleared in 2002, which is a different class of device with different regulatory requirements and evaluation methods compared to AI/ML diagnostic tools.
Here's why the requested information cannot be extracted from the provided text:
- Device Type: The Visage® Wands are an electrosurgical device for cutting, coagulation, and ablation, not an AI/ML diagnostic or predictive tool. Performance is typically assessed through engineering tests, biocompatibility, sterilization validation, and often animal or cadaver studies, rather than clinical studies with human readers or AI algorithms.
- Regulatory Era: This submission dates back to 2002. Regulatory expectations for clinical evidence, especially for demonstrating performance against specific numerical acceptance criteria, have evolved significantly since then. For electrosurgical devices, the focus was often on substantial equivalence to predicate devices based on intended use, materials, product specifications, and energy requirements, supported by bench testing and sometimes preclinical animal studies.
- Nature of "Performance Testing": The document states, "performance testing has been completed to demonstrate the safe and effective use of the Visage Wands in the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels." This "performance testing" refers to general engineering and safety tests (e.g., power output, safety features, material compatibility) rather than a clinical study with detailed statistical analysis, sample sizes, and ground truth establishment in the way AI/ML devices are evaluated.
- Lack of AI/ML Component: There is no mention of any AI or machine learning component in this device. Therefore, concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," "training set," or "test set" as understood in AI/ML validation are not applicable.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details for an AI/ML device based on this document.
The document primarily focuses on:
- Intended Use and Indications: Clearly defining what the device is for and the specific procedures it can be used in.
- Substantial Equivalence: Comparing the device to legally marketed predicate devices to demonstrate that it is as safe and effective.
- Regulatory Classification: Identifying the relevant CFR section and product code.
If you were to search for similar information for an AI/ML device, you would need a 510(k) summary or an FDA Decision Summary that explicitly details the clinical performance study, often found in sections describing "Non-Clinical Data" (for bench/software testing) and "Clinical Data" (for human studies).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.