(128 days)
The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The handpiece is comprised of a disposable, single use plastic handle with internal and external electrodes.
The provided text is a 510(k) summary for the InMode RF System, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182325) rather than providing detailed acceptance criteria and a study proving those criteria for a novel device.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the given document.
Here's an attempt to answer what can be extracted or inferred, and explicitly state what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document does not explicitly state specific numerical acceptance criteria for performance. Instead, it relies on demonstrating that the InMode RF System's performance is "as predicted" or "virtually identical" to the predicate device.
Reported Device Performance:
| Performance Metric | Reported Performance |
|---|---|
| RF frequency and output (new handpieces) | "as predicted with respect to RF specifications (waveform, amplitude, frequency, crest factor)" |
| RF power density (new handpieces vs. predicate) | "virtually identical" based on measurements of tissue thermal response |
| Thermal effect (previously cleared system) | Evaluated through comparative bench testing |
| Software validation | Met system requirements |
| Electrical and mechanical safety (IEC 60601-1) | Met system requirements |
| Electromagnetic compatibility (IEC 60601-2-2) | Met system requirements |
| Safety and effects of new handpieces on tissues | Demonstrated safety and effects on muscle, liver, and fat (ex vivo) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "three different tissue types, muscle, liver, and fat" for the ex vivo study. The number of samples within each tissue type is not provided.
- Data Provenance: The studies are described as "ex vivo tissue study" and "nonclinical performance test," indicating that the data is from laboratory (bench) testing, not from human patients or a specific country. This implies it's a retrospective analysis of experimental data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable / Not provided. The studies described are non-clinical (ex vivo tissue and bench testing), not involving human diagnostic interpretation where expert ground truth would typically be established. The "ground truth" for the device's performance is based on direct measurements and physical principles (e.g., RF specifications, thermal response).
4. Adjudication Method for the Test Set
Not Applicable / Not provided. Since there's no human diagnostic interpretation of cases, an adjudication method for a test set is not relevant in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document describes a medical device generating RF energy, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This device is a treatment system (electrosurgical) and not an AI algorithm performing a diagnostic task. The "standalone performance" is its ability to generate RF energy and achieve the stated effects.
7. The Type of Ground Truth Used
For the non-clinical studies:
- For RF frequency and output: Engineering specifications and direct measurements against those specifications (e.g., "waveform, amplitude, frequency, crest factor").
- For RF power density: Measurements of tissue thermal response.
- For safety and effects on tissues: Direct observation and measurement of effects on ex vivo muscle, liver, and fat tissues.
- For software, electrical/mechanical safety, EMC: Compliance with international standards (IEC 60601-1, IEC 60601-2-2) and internal system requirements.
8. The Sample Size for the Training Set
Not applicable / Not provided. This document does not describe the development of an AI algorithm that would typically have a "training set." The system's design and operation are based on engineering principles and existing technology.
9. How the Ground Truth for the Training Set Was Established
Not applicable / Not provided. As there's no mention of an AI algorithm or a training set, the establishment of ground truth for such a set is irrelevant to this document.
§ 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.