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The NuEra Tight RF Model OptiStream is intended:

• to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face.
• 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. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.

The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.

The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as single use, with specific connectors on the panel below the front tray of the main control unit.

One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate.

One massage handpiece is provided to be used to add a mechanical treatment to the heat emission.

All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode.

A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button. The Pause Handpiece can be used to pause the treatment without using the GUI.

The labeling changes proposed in this submission are to clarify that the use of the device to provide topical heating to increase local circulation is not limited to the body but can also include the face with the exception being within the orbital rim and on the neck.

The provided text is a 510(k) summary for a medical device (NuEra Tight RF Model OptiStream), which focuses on establishing substantial equivalence to a predicate device. It does not describe a study involving an AI algorithm or a device that meets acceptance criteria through AI performance metrics. Therefore, I cannot generate the requested information about acceptance criteria and study proving AI device performance.

The document discusses:

• Device Name: NuEra Tight RF Model OptiStream
• Intended Use: Topical heating for pain relief, muscle spasms, increased local circulation (body and face), and temporary reduction of cellulite.
• Comparison to Predicate: The submission is primarily to update the indication statement to include use on the face and to introduce an additional 10mm electrode.
• Performance Data: Refers to literature, bench testing, and clinical testing on the face to support the proposed labeling changes, and testing of the 10mm electrode. It states that the device is able to "induce and maintain such a temperature on the face" (referring to 42°C for face, as opposed to 45°C for body).

There is no mention of:

• Acceptance criteria for an AI algorithm
• Performance metrics like sensitivity, specificity, accuracy, or AUC
• Sample sizes for a test set or training set for AI
• Expert annotation or ground truth adjudication for AI
• MRMC studies or standalone AI performance

Therefore, I am unable to fulfill your request as it pertains to AI device performance.

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