(140 days)
The AliTight device is intended for use in the non-invasive heating of facial skin.
The AliTight device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the AliTight device and the AliTight power supply.
The provided text is a 510(k) summary for the AliTight device, an electrosurgical cutting and coagulation device. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving the device meets those criteria, especially regarding AI-driven performance.
The document primarily focuses on showing the AliTight device's substantial equivalence to a predicate device (Pollogen Ltd., STOP U K140255) based on technological characteristics and compliance with general safety and performance standards (e.g., IEC 60601 series).
Here's a breakdown of what is in the document related to performance, and why it doesn't meet your request:
What is present regarding performance:
- "Performance Data" Section: This section states:
- "ALIC IOTECH conducted several performance tests to demonstrate that the AliTight device complies with performance standards and that it functions as intended."
- "Verification test demonstrating that the AliTight device meets the system's technical specifications for the over-heating safety and RF power output."
- "The AliTight device software was validated as required."
- "In all instances the AliTight device functioned as intended and observations were as expected."
- "Performance Standards" Section: Lists several IEC standards the device complies with, primarily general electrical safety, EMC, usability, and software lifecycle.
Why the document does not meet your request for AI-specific performance and study details:
- AI is Not Mentioned: The term "AI," "artificial intelligence," "machine learning," or any related concepts are not present anywhere in this 510(k) summary. The device, AliTight, is described as delivering "RF current into the skin to generate heat through electrical impedance." The "software" mentioned is for general device control and safety mechanisms, not for diagnostic or AI-assisted interpretation of medical images/data.
- No Clinical Study Details for Acceptance Criteria: The document mentions "performance tests" but does not provide:
- A table of acceptance criteria (e.g., specific sensitivity, specificity, accuracy targets).
- Reported device performance metrics against such criteria.
- Details on sample size for test sets, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types.
- Information about training sets (sample size, ground truth establishment).
Conclusion based on the provided text:
The AliTight device, as described in this 510(k) summary, is an electrosurgical device for non-invasive skin heating. It is not an AI-driven device for which the requested performance study details would typically be documented. The "performance data" referred to in the document pertains to general functional verification, safety mechanisms (like temperature sensing and RF power output), and software validation, aligning with typical electrical medical device requirements, not AI-specific validation.
Therefore, I cannot populate the table or provide the requested details because the source document does not contain information about an AI component or a study meeting your detailed criteria for AI device validation.
§ 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.