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to provide topical heating for the purpose of elevating tissue temperature for the treatment of 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.
to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity.

Device Description

NuEra Tight RF and NuEra Tight RF Plus are 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,

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 models 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 intended to be used with a small amount (approximately 1 mm layer) of an RF conductive cream (Parker Redux cream, cleared under K782055, or similar cream available in the US). The purpose of the cream is to provide aid to transfer the heat.

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 is an optional accessory can be used to pause the treatment without using the GUI.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "NuEra Tight RF and NuEra Tight RF Plus" devices, focusing on the addition of an abdominal circumference reduction indication. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Effectiveness)	Reported Device Performance
Primary Effectiveness	Statistically significant change in mean circumferential measurement at 12 weeks post last treatment compared to baseline.	1 MHz Group (n=23): Statistically significant reduction in mean waist circumference at 12 weeks follow-up.
2 MHz Group (n=18): Statistically significant reduction in mean waist circumference at 12 weeks follow-up.
Secondary Effectiveness	Improvement in skin laxity compared to baseline at 4 and 12 weeks post last treatment.	Blinded assessors identified improvement in skin laxity in a majority of subjects at 4 and 12 weeks follow-up.
	Aesthetic improvement compared to baseline at 4 and 12 weeks post last treatment.	Investigators and subjects reported improvement in aesthetic appearance (GAIS score) in the majority of each group. Blinded reviewers correctly identified 'before' and 'after' pictures for most subjects.
Safety	Acceptable levels of subject discomfort and pain during treatment.	Median VAS Score was 0, with 50% reporting no pain/discomfort. Average pain across all treatment arms was 1.6 (low-level).
	Low incidence and severity of device-related adverse events.	One mild burn (2 MHz arm) resolved with no action (0.3% of treatments). Two mild AEs (diarrhea, back pain) possibly related, resolved with no action. No serious AEs.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Enrollment: 82 subjects were enrolled and randomized.
- Effectiveness Analysis (Primary Endpoint): n=23 for the 1 MHz group and n=18 for the 2 MHz group. This reflects subjects who completed at least 3 of 4 treatment sessions.
Data Provenance: The study was a "multi-center" study, implying data from multiple locations, likely within one or more countries. The document does not explicitly state the country of origin. It was a prospective, randomized study.

3. Number of Experts and Qualifications for Ground Truth

For Skin Laxity and Aesthetic Appearance: "Blinded assessors" and "blinded reviewers" were used to evaluate before/after pictures and identify improvements.
Qualifications: The document does not specify the exact number or qualifications of these assessors/reviewers (e.g., radiologist with 10 years of experience). It just indicates they were "blinded."

4. Adjudication Method for the Test Set

The document describes "blinded assessors" and "blinded reviewers" for evaluating photographic evidence for skin laxity and aesthetic appearance. It does not mention a specific adjudication method like 2+1 or 3+1 for resolving discrepancies, implying a consensus or majority opinion approach might have been used, or that the "majority" finding was sufficient. For quantitative measurements like circumference, direct measurement itself serves as the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Human-in-the-loop (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The device in question is a medical aesthetic device (radiofrequency energy for tissue heating, circumference reduction, cellulite, and skin laxity), not an AI-based diagnostic or interpretative tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical RF energy delivery system, not an algorithm or software designed to operate without human intervention in a diagnostic or analytical capacity. Therefore, a standalone performance evaluation in the context of an algorithm would not be relevant. The "standalone" performance here relates to the device's ability to achieve the intended physiological effects.

7. Type of Ground Truth Used

Primary Effectiveness (Circumference Reduction): Objective measurements of waist circumference.
Secondary Effectiveness (Skin Laxity & Aesthetic Appearance): Expert assessment (blinded assessors/reviewers) of photographic evidence and subjective reports from investigators and subjects (GAIS score).
Safety: Directly observed adverse events and patient-reported discomfort/pain levels (VAS score).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or a separate training phase for the device itself. The clinical study described is the primary efficacy and safety study. As this is not an AI/ML device in the traditional sense, a specific "training set" for an algorithm is not applicable. The device's operational parameters are based on established RF technology and prior predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a discrete "training set" for an algorithm, separate from the clinical validation study, is not described or relevant for this type of device. The "ground truth" for the device's design and operational parameters would have been established through engineering principles, pre-clinical testing, and knowledge gained from predicate devices.

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