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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 periorbital wrinkles and rhytids including the upper and lower eyelids
• Non-invasive treatment of facial wrinkles and rhytids

The Thermage ThermaCool System consists of the following components:

• ThermaCool System .
• Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
• Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper
• Accessory cables and tubing
• Optional footswitch component ●

This 510(k) premarket notification is for the Thermage ThermaCool System seeking an expanded indication for the non-invasive treatment of periorbital wrinkles and rhytids, including the upper and lower eyelids. The core information requested about acceptance criteria and a study to prove performance is not explicitly present in the provided text.

The document states that the "technological characteristics of the Thermage ThermaCool System for Eyelid Indications are identical to the cleared system" and that the device is "substantially equivalent to referenced devices currently cleared for marketing in the United States."

This implies that the previous clearance (K043042) for the Thermage ThermaCool System likely established the initial acceptance criteria and associated performance studies. For this 510(k), the focus is on demonstrating safety and effectiveness for a new indication (eyelid treatment) based on the existing, already-cleared technology. The document doesn't detail a new, standalone study for this specific expanded indication with explicit acceptance criteria provided.

Therefore, many of the requested data points (sample size of test set, ground truth experts, adjudication, MRMC, standalone study, training set details) are not directly addressed for this specific 510(k).

However, I can extract what is provided and explain the implications:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or detailed performance data for the new eyelid indication are presented in this document. The submission relies on the substantial equivalence to previously cleared devices.

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

• Sample Size: Not specified in this document for the new indication.
• Data Provenance: Not specified in this document for the new indication. The submission relies on the existing clearance of the same device.

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

Not specified in this document for the new indication.

4. Adjudication method for the test set:

Not specified in this document for the new indication.

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:

Not applicable. This device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study is mentioned or relevant to this type of device.

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

Not applicable. This device is an electrosurgical unit, not an algorithm.

7. The type of ground truth used:

Not specified for this 510(k). For a medical device like this, ground truth would typically be established through clinical outcomes, clinician assessments, or standardized photographic evaluations in a clinical trial setting. However, for a 510(k) seeking an expanded indication for an already cleared device, the ground truth for the original clearance would have been used.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary based on the provided text:

The Thermage ThermaCool System's 510(k) for the expanded eyelid indication does not contain a new, detailed study with explicit acceptance criteria and performance results in the provided text. Instead, it leverages the concept of substantial equivalence to existing, cleared devices (specifically, the previous clearance K043042 for the ThermaCool System itself for other wrinkle/rhytid indications).

The application asserts that the "technological characteristics... are identical to the cleared system" (for K043042). This means that the safety and effectiveness for this new indication are presumed to be similar to the already-cleared indications because the underlying technology is the same. The FDA's letter confirms that they have determined the device is substantially equivalent for the stated indications for use.

To fully understand the acceptance criteria and study proving performance, one would need to review the original 510(k) submission (K043042) for the Thermage ThermaCool System, which would have contained the detailed clinical data for its initial clearance for wrinkle and rhytid treatment. This current 510(k) is an extension of that initial clearance.

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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.

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The Thermage ThermaCool System is indicated for use in:

• The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis.
• Non-invasive treatment of periorbital wrinkles and rhytids. .
• Non-invasive treatment of facial wrinkles and rhytids. .

The Thermage ThermaCool System consists of the following components:

• ThermaCool System ●
• Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
• Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
• Accessory cables and tubing .
• Optional footswitch component .

The provided document is a 510(k) Safety Summary for the Thermage ThermaCool System Treatment Tip, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

The document focuses on:

• Identifying the device and its classification.
• Listing predicate devices.
• Describing the device components and its intended uses.
• Stating that its technical characteristics are "substantially equivalent" to cleared predicate devices.
• Confirming FDA's substantial equivalence determination.

Therefore, I cannot provide the requested information, as it is not present in the given text.

Ask a specific question about this device

The Thermage ThermaCool System is indicated for use in:

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

The Thermage ThermaCool System consists of the following components:

• RF Generator .
• Cooling Module ●
• Cryogen Canister .
• Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
• Accessory cables and tubing .
• Optional footswitch component .
• Accessories: coupling fluid, return pad and skin marking paper .
  The Handpiece Assembly and Cooling Module connect to the RF Generator.

This document is a 510(k) premarket notification for the Thermage ThermaCool System. It focuses on demonstrating substantial equivalence to a predicate device and safety aspects like sterilization and biocompatibility rather than demonstrating the performance of an AI/ML device against specific clinical acceptance criteria through a study.

Therefore, many of the requested sections about AI/ML device performance studies, such as sample sizes for test and training sets, ground truth establishment, MRMC studies, and stand-alone performance, are not applicable to the information provided.

However, I can extract information related to quality control and safety acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes compliance with sterilization and biocompatibility standards, and substantial equivalence, not a clinical efficacy or performance study with a test set of data in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for clinical performance for an AI/ML device is not mentioned as this is a 510(k) for an electrosurgical unit.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of a test set.

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

Not applicable. This device is not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is an electrosurgical unit, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the compliance aspects (sterilization, residuals), the "ground truth" is defined by adherence to established international standards (EN 550, ISO 10993-7) and regulatory requirements (21 CFR 801.150). For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device (ThermaCool TC, K021402).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable. There is no mention of a training set or its ground truth.

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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.

The Thermage ThermaCool System consists of the following components: - ThermaCool System . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) . - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper - Accessory cables and tubing . - Optional footswitch component ●

The provided text is a 510(k) summary for the Thermage ThermaCool System. It explicitly states that the device is substantially equivalent to predicate devices based on design, principle of operation, materials, and intended use. However, it does not contain specific information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the available information, noting where details are missing:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Thermage ThermaCool System (K033942) does not include a table of acceptance criteria or a study demonstrating the device's performance against such criteria. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than reporting on specific performance outcomes from a dedicated study.

Missing Information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Explanation of document content:

The 510(k) summary (K033942) for the Thermage ThermaCool System asserts its substantial equivalence to previously cleared Thermage ThermaCool systems (e.g., K021402, K013639, K013034, K003183, K000944) and the ThermaCool Coupling Fluid TF-2 (K030142).

The key statement regarding its compliance is:

"By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently cleared for marketing in the United States."

This indicates that the device's technological characteristics, indications for use (Dermatologic and General Surgical procedures for electrocoagulation and hemostasis, and non-invasive treatment of periorbital wrinkles and rhytids), and safety profile are considered comparable to those of already approved devices, rather than being evaluated against new, specific performance acceptance criteria in a dedicated study documented here.

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The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

The Thermage ThermaCool System consists of the following components.

• RF Generator .
  Handpiece Connection Module .
• Cooling Module .
• Handpiece Assembly (consisting of Handpiece and RF Electrode Insert), and .
  Accessory cables and tubing. .
  The Handpiece Assembly connects to the distal end of the Handpiece Connection Module and to the distal end of the Cooling Module. The proximal end of the Handpiece Connection Module and the proximal end of the Cooling Module connect to the RF Generator.
  The Thermage ThermaCool System is monopolar. Commercially available dispersive electrodes (return pads) are required for operation.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) premarket notification summary for the Thermage ThermaCool System, focusing on its substantial equivalence to predicate devices for its intended use in electrocoagulation and hemostasis. It describes the device, its classification, and declares its substantial equivalence based on design, principle of operation, materials, and intended use.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.

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