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The Thermage ThermaCool System is 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. 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 Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the context of typical medical device performance evaluation (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a ThermaCool NXT Multiplex Assembly, an electrosurgical unit and accessories.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria as you've requested. Substantial equivalence is determined by comparing the new device's technological characteristics and intended use to those of legally marketed predicate devices.

Therefore, many of the specific details you asked for (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not present in the provided text.

However, I can extract the relevant information regarding the equivalence claim:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. The document does not describe a performance study with a test set. The evaluation is based on a comparison of design, materials, and intended use to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth establishment is described for a performance study.

4. Adjudication method for the test set

• Not Applicable. No performance study or test set described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI-assisted device, and no MRMC study is described. The device is an electrosurgical unit.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm-based device.

7. The type of ground truth used

• Not Applicable. No ground truth is described for a performance study. The "ground truth" for a 510(k) substantial equivalence submission is essentially the legally marketed predicate devices and their established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this device is not based on machine learning or AI.

9. How the ground truth for the training set was established

• Not Applicable. No training set is mentioned.

Summary of the Study (or Basis for Clearance):

The "study" or basis for clearance here is a 510(k) Premarket Notification which asserts substantial equivalence of the ThermaCool NXT Multiplex Assembly to legally marketed predicate devices (K033942, K032088, K031046, K043402, K051710, K052778).

The crucial elements for this type of submission are:

• Device Description: The Multiplex Assembly is a 4-electrode design with a ceramic coolant spreader. The handpiece, coupling fluid, return pad, and skin marking paper were modified to accommodate larger tip dimensions.
• Intended Use: The indications for use match those of the predicate devices: dermatologic and general surgical procedures for electrocoagulation and hemostasis, non-invasive treatment of wrinkles and rhytids (including periorbital), temporary improvement in the appearance of cellulite, temporary improvement in local circulation, and relief of minor muscle aches/pains and muscle spasms.
• Technological Characteristics: The manufacturer claims the technological characteristics are "substantially equivalent." This means there were no new questions of safety or effectiveness raised by the device's design, materials, or principle of operation compared to the predicates.

Essentially, the device was cleared because it was deemed to be equally safe and effective as existing, legally marketed devices. There was no need for a new clinical performance study with specific metrics like sensitivity or specificity because the design changes were considered minor enough not to alter fundamental safety or efficacy.

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The Thermage ThermaCool System is indicated for use in:

• Dermatologic and general surgical procedures for electro coagulation and hemostasis
• Non-invasive treatment of wrinkles and rhytids

This special 510(k) application covers a system identical to the earlier devices and clearances.
The Thermage ThermaCool System consists of the following components:
*RF Generator
*Cooling Module
*Cryogen Canister
*Handpiece Assembly (consisting of Handpicce and Treatment Tip)

• Accessory cables and tubing
  *Optional footswitch component
• Accessories: coupling fluid, return pad and skin marking paper

The provided text describes a 510(k) premarket notification for the Thermage ThermaCool System, focusing on its substantial equivalence to a predicate device and its indications for use. It does not contain information about acceptance criteria, device performance, study design, or ground truth establishment.

Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report.

Ask a specific question about this device