(58 days)
The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/hanpieces and accessories) are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue
The Thermi Temperature Controlled Radiofrequency (RF) System consists of a RF generator with integral temperature and impedance feedback, automatically adjusting energy delivery to maintain set temperature and percutaneous and transcutaneous electrodes accessories that deliver the RF to the targeted location on the patient's anatomy when use with Thermi RF generator. It is operating with set temperature range between 35-90° C that allows the physician to control treatment temperature to achieve the desired clinical outcome.
The Thermi RF System consist of:
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- RF Generator
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- Percutaneous electrodes
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- Disposable and re-usable transcutaneous electrodes/handpieces
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- Foot pedal
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- Power cord
Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue.
The provided text describes the regulatory filing for the Thermi Temperature Controlled Radiofrequency (RF) System (K173582). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for establishing acceptance criteria for a new clinical performance claim. As such, the information typically requested for AI/software-as-a-medical-device (SaMD) performance studies (such as sample size, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this context.
The "Performance Data" section primarily details bench testing and compliance with electrical safety and essential performance standards to ensure the device's basic functionality and safety, rather than its clinical efficacy in achieving specific medical outcomes.
Here's an attempt to populate the table and answer the questions based on the provided text, recognizing its limitations for the requested information:
Acceptance Criteria and Device Performance (Based on Bench Testing)
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Functional & Performance | Device operates within specified parameters (implicit from "works within the device parameters ranges"). | "Met all performance and functional testing and performed as intended." "Works within the device parameters ranges of the legally marketed Thermi RF System with the same indications for use." |
| Design Specifications | Verification of design specifications based on internal protocols. | "Verified design specifications" (implied by completion of testing). |
| Electrical Safety | Compliance with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-2. | "Completed on the subject Thermi Temperature Controlled Radiofrequency System in accordance with FDA Guidance." "Show that... met all... testing." |
| Software Validation | Software functional and performance verification, and software validation. | "Software functional and performance verification," "Software Validation" (listed as completed tests, implying successful outcome). |
| Biocompatibility | Compliance with biocompatibility standards. | "Biocompatibility testing" (listed as completed test, implying successful outcome). |
| Safety | No new safety or performance questions raised. | "Did not raise new safety or performance questions." "No new questions of safety or efficacy are raised." |
Additional Information Not Directly Applicable to AI/SaMD Performance Studies:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. The document describes bench testing on the device itself and its components, not clinical data from patients or a test set of medical images/data.
- Data Provenance: Not applicable. The tests were performed in a lab setting, not on patient data.
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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 as typically defined for AI/SaMD (e.g., expert consensus on medical images) is not relevant to this type of device submission which focuses on the engineering and electrical safety aspects of an RF system. The "ground truth" here is the adherence to design specifications and safety standards as assessed by engineers and test equipment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring expert adjudication.
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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 a medical device for electrocoagulation and lesion creation, not an AI/SaMD for assisting human readers. An MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an RF generator and accessories, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is adherence to engineering specifications, recognized national and international safety standards (e.g., IEC 60601 series), and internal design requirements. For example, for "Thermal effect on tissue testing," the ground truth would be the expected and measured temperature distribution and tissue changes according to the device's intended operation and safety limits, as determined by pre-defined protocols and scientific understanding of RF tissue interaction.
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The sample size for the training set:
- Not applicable. This is not an AI/SaMD, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/SaMD.
§ 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.