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The radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in:

• Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
• Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
• Non-invasive treatment of wrinkles and rhytids.

The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool NXT System and Accessories is indicated for use in:

• Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
• Non-invasive treatment of periorbital wrinkles and rhytids;
• Non-invasive treatment of wrinkles and rhytids;
• Temporary improvement in the appearance of cellulite;
• Relief of minor muscle aches and pains;
• Relief of muscle spasms:
• Temporary improvement of local circulation (i.e., blood circulation).

The Thermage ThermaCool NXT System delivers capacitively coupled radiofrequency energy while cooling tissue by conduction. Components and accessories include the Multiplex (16.0) Handpiece, Standard Handpiece, Treatment Tips, Return Pad, Electronic Footswich (optional), Cryogen Canister and Coupling fluid. The front panel of the ThermaCool NXT System is equipped with a receptacle to connect the Return Pad to each Handpiece Assembly, comprising the return path for electric current. The modified Standard Handpiece offers user-selectable vibration to provide concurrent mechanical manipulation of tissue in a manner similar to the predicate devices listed.

This 510(k) submission (K090580) for the Thermage ThermaCool NXT System (TG-2B) provides a safety summary, but it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

The document states in section F, "Summary": "By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool NXT System and Accessories is substantially equivalent to devices currently cleared for marketing in the United States." This indicates that the device was cleared based on substantial equivalence to predicate devices, rather than new clinical effectiveness or performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory classification, predicate devices, and intended use.

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The TherMassager is indicated for use in:

• Relief of minor muscle aches and pains
• Relief of muscle spasm
• Temporary improvement of local circulation (i.e., blood circulation)
• Temporary improvement in the appearance of cellulite

The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. This document is a 510(k) premarket notification for a therapeutic massager, the TherMassager.

Instead, the document details the device's substantial equivalence to a predicate device (UPC Therapeutic Massager, K990445) based on a comparison of device characteristics and intended use. The core of this submission is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present novel performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because this type of data is not present in the provided 510(k) summary.

The closest information available related to "acceptance criteria" is the comparison of device characteristics to the predicate device to establish substantial equivalence.

Here's a breakdown of what can be extracted or inferred based on the document's content, acknowledging the limitations for your specific request:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in a format of "acceptance criteria" versus "reported performance." Instead, the document presents a side-by-side comparison of features between the TherMassager and the predicate device (LPG). Substantial equivalence is the "acceptance criteria" here, meaning the device's characteristics and performance are similar enough to the predicate to be considered safe and effective for the same indications.

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