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The ThermaCool TC System is indicated for use in

• Non-invasive treatment of periorbital rhytids and wrinkles
• Dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The device as described in the above referenced Premarket Notifications has been modified to include a modified Skin Marking Paper.

The provided document is a 510(k) premarket notification for the ThermaCool TC System. It describes a modification to an existing device, specifically a modified "Skin Marking Paper." This document focuses on establishing substantial equivalence to previously cleared devices (K013639 and K021402), rather than presenting a new study with acceptance criteria and device performance evaluation in the format requested.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in this document.

The document states:

• "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
• It refers to "in-house Standard Operating Procedures and QSR based vendor qualification procedures" for manufacturing, but these do not constitute device performance acceptance criteria or a study proving those criteria are met for the device itself in terms of clinical or technical effectiveness.
• The FDA letter confirms that a substantial equivalence determination was made based on the indications for use provided.

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The ThermaCool TC System is indicated for use in

• . Non-invasive treatment of periorbital rhytids and wrinkles
• . Dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The device as described in the above referenced Premarket Notifications has been modified to include a modified Treatment Tip.

The provided text is a 510(k) Premarket Notification for the "ThermaCool TC System." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical or AI performance study would.

The document states:

• "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
• "However, voluntary standards such as in-house Standard Operating Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device."

Therefore, based solely on the provided text, I cannot extract the requested information. The document serves as a regulatory submission demonstrating equivalence, not a detailed performance study with acceptance criteria.

To answer your specific questions based on the provided document:

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

   • Not available in the provided text.
   • The document implies that "voluntary standards such as in-house Standard Operating Procedures" are used, but no specific performance metrics or acceptance criteria are listed.

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

   • Not available in the provided text. This document does not describe a clinical test set or data.

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. This document does not describe a study involving expert-established ground truth.

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

   • Not applicable.

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 system, not an AI diagnostic tool.

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

   • Not applicable. This device is an electrosurgical system, not an AI algorithm.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

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The ThermaCool TC System is indicated for use in

• Non-invasive treatment of periorbital rhytids and wrinkles .
• Dermatologic and general surgical procedures for electrocoagulation and . hemostasis.

The device as described in the above referenced Premarket Notifications has been modified to include a reformulated Coupling Fluid.

This 510(k) premarket notification for the ThermaCool TC System primarily concerns a modification to an existing device, specifically a reformulated Coupling Fluid. The submission explicitly states that "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document focuses on establishing substantial equivalence to previously cleared devices (K013639 and K021402) for the modified system (specifically the new coupling fluid), rather than demonstrating a new performance for the entire ThermaCool TC System. Substantial equivalence for this type of modification often relies on comparing material properties and safety, rather than extensive clinical performance studies with specific statistical metrics.

Here's why the prompt's requested information is not available in the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not present. The document does not define specific performance metrics or acceptance criteria for the device or its new coupling fluid.
• 2. Sample size used for the test set and the data provenance: Not present. There is no mention of a test set, sample size, or data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth is not discussed as there is no performance study.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
• 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 present. This is not an AI-assisted device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This is not an AI algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not present.
• 8. The sample size for the training set: Not present.
• 9. How the ground truth for the training set was established: Not present.

The key takeaway is that this 510(k) is for a minor modification (coupling fluid reformulation) to an already cleared device, and thus, the submission primarily addresses the substantial equivalence of this modification, not a comprehensive performance study of the entire system as if it were a novel device.

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The Thermage ThermaCool TC System (Model TC) 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 TC 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove that the device meets specific criteria.

The document provided is a 510(k) premarket notification summary for the Thermage ThermaCool TC System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It also includes the FDA's clearance letter.

This type of document typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance acceptance criteria and study results in the manner you described for an AI/ML device. The "technological characteristics and clinical use data" mentioned are used to establish substantial equivalence to predicate devices, but the specifics of any performance evaluations or clinical trials for this particular device (beyond what's needed for the 510(k) process) are not detailed in this excerpt.

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance or details about study design elements like sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources, or training set information.

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

The Thermage ThermaCool TC System consists of the following components:

• RF Generator .
• Coolant Control Center ●
• Coolant 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 Coolant Control Center connect to the RF Generator.

Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the Thermage ThermaCool TC System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria (e.g., target accuracy, sensitivity, specificity, or specific performance metrics) that the Thermage ThermaCool TC System had to meet. Instead, the submission relies on the concept of substantial equivalence to predicate devices. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device has "substantially equivalent" technological characteristics and intended use to previously cleared devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic performance. The submission relies on establishing substantial equivalence through a comparison of technological characteristics and intended use with predicate devices. Therefore, there is no mention of a specific sample size for a test set, nor is there information about data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there is no described clinical study with a "test set" or diagnostic performance evaluation, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Since no test set or diagnostic performance study is described, there is no information about an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The submission focuses on substantial equivalence rather than comparative effectiveness with human readers.

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

This device is an electrosurgical unit, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The submission focuses on the safety and effectiveness of the medical device itself through substantial equivalence.

7. The Type of Ground Truth Used

Given that this is a 510(k) submission for an electrosurgical unit based on substantial equivalence, the "ground truth" is effectively derived from the established safety and effectiveness of the predicate devices. There is no mention of pathology, outcomes data, or expert consensus in the context of demonstrating this device's performance against a specific "ground truth" for a diagnostic task.

8. The Sample Size for the Training Set

This submission is for a medical device (electrosurgical unit), not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply.

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

As this is not an AI/machine learning device, the concept of establishing "ground truth for a training set" is not applicable.

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