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K Number
K031046
Device Name
THERMACOOL TC SYSTEM
Manufacturer
THERMAGE, INC.
Date Cleared
2003-05-22

(50 days)

Product Code
GEI
Regulation Number
878.4400
Type
Special
Panel
SU
Reference & Predicate Devices
K013639,K021402
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.
Device Description

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

AI/ML Overview

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.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.