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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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