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The NuEra Tight RF Model APMD145.M70-US is intended for:

• to provide topical heating for the purpose of elevating 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. 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 reusable or 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.
  A new accessory, proposed in this submission, is the Handsfree Accessory. The Handsfree will enable the same treatment without requiring the operator to manually move the handpiece and connected electrode over the entire treatment area. This is because the Handsfree electrodes (up to 8) can be connected together in a row with a belt, and also used with a double-sided adhesive tape, to better attach to the entire treatment area.

The provided text is a 510(k) Summary for the NuEra Tight RF Model APMD145.M70-US. It describes a medical device, which is an electrosurgical cutting and coagulation device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, accuracy, or any clinical trial results typically associated with establishing device effectiveness against specific endpoints.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K210867) by introducing a "Handsfree Accessory." The "Performance Data and Bench Test" section briefly mentions verification and validation were performed on the Handsfree accessory using methods established by the predecessor device and in accordance with several standards (EN 60601-1, EN 60601-1-2, IEC 62304, ISO 14971). It concludes that "Testing confirms that the Handsfree operates in accordance with the same principles as the cleared electrodes in the predicate, which is to maintain the selected temperature at the treated site."

This level of detail is insufficient to answer the questions posed, as it does not present:

1. A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., in terms of temperature accuracy, duration of elevated temperature, or reduction in cellulite appearance quantified with specific measurements) are provided, nor are numerical acceptance criteria discussed.
2. Sample size and data provenance: No information is given about sample sizes for any tests, nor the provenance of any data (e.g., country of origin, retrospective/prospective).
3. Number and qualifications of experts for ground truth: No experts are mentioned in relation to establishing ground truth, as there are no clinical performance measures reported.
4. Adjudication method: Not applicable as no ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device treats patients directly and does not involve human readers interpreting AI output.
6. Standalone performance: While the device acts in a standalone manner, the document doesn't provide detailed performance data typically associated with a standalone study. The "performance data" mentioned refers to bench testing for safety and functional equivalence.
7. Type of ground truth: No specific ground truth (pathology, outcomes data, expert consensus) is discussed regarding device performance, as the primary focus is on safety and functional equivalence to the predicate, specifically for the new accessory. The statement "maintain the selected temperature at the treated site" implies a functional goal, but not how "ground truth" for this was established beyond physical measurement.
8. Sample size for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical medical device and its new accessory, emphasizing safety and functional similarity to a predicate. It does not contain the kind of detailed performance criteria, study data, or ground truth establishment typically found in studies for diagnostic or AI-powered devices measuring specific efficacy or accuracy outcomes.

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