(28 days)
The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.
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 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 hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.
The provided text describes the 510(k) premarket notification for the InMode RF System, focusing on its substantial equivalence to a previously cleared device. The document does not contain information about explicit acceptance criteria with numerical thresholds for performance metrics and a study directly demonstrating the device meets these specific criteria. Instead, it details that the device complies with recognized consensus standards and underwent non-clinical (bench) and ex-vivo animal performance testing to support its substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or corresponding reported device performance values. It states that the device "complies with the following FDA recognized consensus standards" and that "The results of the bench tests demonstrate that the InMode RF System with the HP172206A hand piece performed in a similar way to the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Bench Performance Data: Not explicitly stated as a number of devices or tests. It mentions "The InMode RF System with the HP172206A hand piece was utilized in bench performance tests."
- Animal Performance Data: The ex-vivo study "was conducted on three different porcine tissue models (muscle, liver & fat)." The number of tests or specific tissue samples within each model is not provided.
- Data Provenance: The studies were conducted by InMode MD Ltd., an Israeli company. The text doesn't explicitly state the country where the studies were performed, but it's reasonable to infer they were likely conducted under the company's purview, possibly in Israel. The studies appear to be prospective in nature, as they involve testing the device (bench and ex-vivo).
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. The studies described are non-clinical (bench and ex-vivo animal studies) and do not involve human subjects or expert assessment of clinical outcomes in the way a diagnostic AI device would. The ground truth for the animal study was established through TTC staining analysis, which is a laboratory technique, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this study does not involve human expert assessment of a test set that would require an adjudication method.
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. The device is not an AI diagnostic tool and does not involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "performance data" presented (bench and animal studies) describes the standalone performance of the device (InMode RF System with the HP172206A hand piece) in achieving electrocoagulation and hemostasis. This is an algorithm-only (or device-only) performance without human-in-the-loop as it's an electrosurgical device, not a diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Performance Data: Ground truth would be based on engineering specifications and measurements to confirm output power, frequency, safety parameters, etc.
- Animal Performance Data: The ground truth for evaluating thermal effects was established via TTC staining analysis.
8. The sample size for the training set
Not applicable. This device is an electrosurgical system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its operation is based on pre-programmed parameters and real-time feedback mechanisms, not learned from a dataset.
9. How the ground truth for the training set was established
Not applicable. As mentioned, there is no "training set" in the machine learning sense for this device. Its development would involve engineering design, testing against physical properties, and safety standards.
§ 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.