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The ThermoTK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The ThermoTK massage device is intended to provide a temporary reduction in the appearance of cellulite.

ThermoTK is a medical diathermy device for external tissue heating on the human skin with the purpose of increasing tissue temperature by applying electromagnetic fields of 460 or 540 KHz.

The device includes a plastic housing with a capacitive touch display which guarantees an easy handling to select and start a treatment. In this housing, an electronic power module is implemented which drives the electromagnetic energy into the connected handpiece. By using the two adjusters, it is possible to set the treatment intensity and treatment time. Two handpieces for two different treatment modes are attached and can be connected to the control unit depending on which treatment mode the therapy has to be performed. An electrode (resistive or capacitive) has to be plugged on the handpiece for treatment. The device also includes two different electrode cables which can be connected with attached common electrodes (self-adhesive or reusable). For a better stability while using the handpiece during application, a silicone spacer can be put between handpiece and electrode.

The provided text is a 510(k) summary for the Zimmer MedizinSysteme GmbH ThermoTK device. It outlines the regulatory clearance process, device description, indications for use, and a comparison to a predicate device (Winback Back 3SE).

However, the document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly available in the provided text. The focus is on showing equivalence through technological characteristics and compliance with general safety and performance standards.

Here's a breakdown of what can and cannot be extracted from the provided document based on your request:

Information NOT available in the document (and why):

• A table of acceptance criteria and the reported device performance specific to a clinical study: The document states "No direct comparison was made since there are no significant differences in operation and test results indicate identical safety." and "According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices." This indicates that performance was assessed against standards for substantial equivalence, not against specific pre-defined clinical acceptance criteria in a study.
• Sample size used for the test set and data provenance: No clinical testing specific to the ThermoTK device's indications of use (pain relief, muscle spasms, cellulite reduction) is described with a test set, sample size, or data provenance. The document only lists compliance with general electrical safety, EMC, usability, software, risk management, and biocompatibility standards.
• Number of experts used to establish ground truth and qualifications: Not applicable as no
  clinical study with ground truth establishment is detailed.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned or implied.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable as there is no mention of machine learning or AI models with training sets.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be inferred or extracted from the document:

The document primarily highlights the acceptance criteria for regulatory clearance through substantial equivalence, which includes:

1. Compliance with recognized voluntary standards: This is the primary "performance data" presented.
2. Technological equivalence to a predicate device.
3. Identical Indications for Use.

Here's how to structure the available information:

Acceptance Criteria and Study for ThermoTK Device (Based on 510(k) Summary K213256)

The provided 510(k) summary for the ThermoTK device emphasizes demonstrating substantial equivalence to a predicate device (Winback Back 3SE - K162828) rather than presenting a standalone clinical performance study with specific acceptance criteria related to its stated indications for use (relief of pain, muscle spasms, increased local circulation, and reduction in cellulite appearance). The "study" in this context refers to the comprehensive testing and comparison performed to secure regulatory clearance.

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance:

• Provide topical heating for elevating tissue temperature to treat selected medical conditions (relief of pain, muscle spasms, increase local circulation).
• Provide temporary reduction in the appearance of cellulite. |
  | Technological Characteristics Equivalence | The device's technological characteristics should be substantially similar to the predicate device, or any differences should not raise new questions of safety or effectiveness. | Similarities: Both are medical diathermy devices for external tissue heating (460/540 KHz vs 300 kHz-1 MHz RF), operate in unipolar/multipolar modes, have intensity adjustments (0-100%), and utilize resistive/capacitive modes.
  Differences: Max RF power (115VA vs 300W), presence of a patient safety switch (No vs Yes for predicate), specific electrode dimensions.
  Conclusion: "There are no significant technological differences... Those differences have been discussed and do not affect device safety or performance. The subject device has all features of the predicate device. ThermoTK does not raise any new types of safety or effectiveness questions." |
  | Voluntary Standards Compliance | The device must meet recognized industry standards for safety and performance relevant to its classification. | The ThermoTK device complied with the following standards:
• ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Electromagnetic disturbances)
• IEC 60601-1-6:2013 (Usability)
• IEC 62366-1:2015 (Usability engineering)
• IEC 62304:2015 (Medical devices software)
• ISO 14971:2019-12 (Application of risk management)
• ISO 15223-1:2016 (Symbols)
• ISO 10993-1:2018, 10993-5:2009, 10993-10:2010 (Biological evaluation/Biocompatibility) |
  | Safety Testing | Demonstrates electrical safety and biocompatibility. | "Electrical safety and biocompatibility have been established for both devices." Compliance with 60601-1 and 10993 series standards is listed as evidence. "Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests." |

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

• The document does not describe a specific clinical "test set" or sample size for validating the efficacy of the ThermoTK device for its indications for use.
• Data provenance is related to compliance with general international standards and internal testing procedures for electrical safety, EMC, usability, and biocompatibility, rather than human clinical data from a specific country or nature (retrospective/prospective).

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

• Not applicable. The clearance is based on technological equivalence and compliance with standards, not on "ground truth" established by experts for clinical performance outcomes in a study.

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

• Not applicable, as no clinical test set requiring adjudication of outcomes is 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, an MRMC comparative effectiveness study was not done. This device is a physical therapeutic device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable for the regulatory clearance process described. The "ground truth" for substantial equivalence is derived from established predicate devices and recognized international standards for device safety and performance.

8. The sample size for the training set:

• Not applicable, as there is no mention of machine learning or AI models with training sets.

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

• Not applicable, as there is no mention of machine learning or AI models with training sets.

In summary, the provided FDA 510(k) summary demonstrates regulatory acceptance primarily through engineering, electrical, and biocompatibility testing against defined standards and a detailed comparison showing substantial equivalence in technological characteristics and indications for use to a legally marketed predicate device, rather than through a traditional clinical trial with efficacy endpoints and human-based ground truth.

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