(180 days)
The NuEra Tight RF Family is intended for:
- to provide topical heating for the purpose of elevaing tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
- to provide, with a massage device, a temporary reduction in the appearance of cellulite.
NuEra Tight RF Family is a family of devices designed to:
- develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient.
Specifically, there are two devices in the family: - -NuEra Tight RF - radiofrequency generator with single RF electrode connector
- -NuEra Tight RF Plus -radiofrequency generator with single RF electrode connector. The device has a different design, in particular for larger size, than the NuEra Tight RF, for the presence of a disabled electronic part that is the object of a different 510(k) submission. The detachable components to be used with the part not available are not provided with the Nuera Tight RF Plus.
The purpose of the treatment based on the radiofrequency system (NuEra Tight) is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
The provided text is a 510(k) summary for the NuEra Tight RF Family device, which is an electrosurgical cutting and coagulation device and accessories that uses radiofrequency energy for topical heating and temporary reduction of cellulite. While it includes information about the device's technical specifications, indications for use, and comparison to predicate devices, it does not contain the specific details required to describe acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/ML-based device evaluation.
The document discusses compliance with electrical safety, EMC, usability, and software verification/validation standards (e.g., IEC 60601-1, IEC 62304, ISO 14971), and functional testing to confirm alignment with technical specifications. It also mentions "a test" performed to demonstrate the device can maintain a set skin temperature within a certain interval.
Here's a breakdown of why the requested information for an AI/ML device is not present in this document:
- No AI/ML Component: The NuEra Tight RF Family device, as described, is a physical medical device (radiofrequency generator) for therapeutic applications. It does not appear to incorporate any artificial intelligence or machine learning components. Therefore, the concepts of "test set," "training set," "ground truth establishment," "expert adjudication," "MRMC studies," or "standalone algorithm performance" as typically applied to AI/ML device evaluations are not applicable to this submission.
- Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This is achieved by comparing indications for use, technological characteristics, safety, and effectiveness. The performance data presented generally focuses on meeting recognized standards for electrical safety, EMC, and functional performance, rather than clinical efficacy studies with specific acceptance criteria in the vein of AI/ML performance metrics.
- Limited Clinical Data Details: While it mentions a "test" to maintain skin temperature across different body parts and patients, the level of detail provided (e.g., sample size for this specific test, the exact acceptance criteria for temperature maintenance, specific results, or how "safety and effectiveness" were conclusively proven beyond general statements) is far less than what would be expected for a detailed clinical study demonstrating AI/ML performance.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study proving device meets acceptance criteria as if it were an AI/ML device, based on the provided text.
The document states:
"In addition, a test was performed and resulted demonstrated that the device can maintain the set skin temperature at 2 set point (minimum: 40°C and maximum: 42°C or 45°C depending on the electrode size) and it can maintain the skin temperature inside that interval of + 2°C for 15 minutes. The test is executed for all electrodes in different parts of the patient (3 different body parts) and it is verified for all RF frequencies (470 kHz, 1 Mhz, 4 Mhz, 6 Mhz). In addition, the subset of tests is executed on different patients (2 additional patients) to demonstrate the independency of the results on a specific patient."
However, this is a functional performance test, not a clinical study to assess diagnostic or therapeutic performance in the way AI/ML devices typically undergo evaluation.
To directly answer your request based only on the provided text, acknowledging the limitations for an AI/ML context:
No information regarding acceptance criteria and a study proving an AI/ML device meets those criteria is available in the provided 510(k) summary. The device described is a physical medical device (radiofrequency generator) that does not appear to incorporate AI/ML technology. The "test" mentioned pertains to the device's ability to maintain skin temperature within a specified range, which is a functional performance test, not an AI/ML performance study.
Therefore, the requested table and answers to questions 2-9 cannot be derived from this document, as they are specific to AI/ML device evaluations.
§ 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.