(281 days)
The CAPENERGY C Devices - C100, C200, C300, C400, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates. The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes. The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel. The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.
The provided text is a 510(k) Premarket Notification for the CAPENERGY C Devices (C100, C200, C300, C400, C50). This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study for the device itself. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance, is not present in this document.
However, based on the non-clinical data section, we can infer some information about performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to reach and maintain therapeutic tissue temperature (40-45°C) on the surface of human skin for at least 10 minutes | "demonstrated ability to reach and maintain therapeutic temperature (40-45℃) on the surface of human skin for at least 10 minutes." |
| Correct operation according to intended use (general) | "Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use" |
| Electrical Safety (IEC 60601-1:2005 + A1:2012) | Compliance met (implied by non-clinical summary) |
| Electromagnetic Compatibility (IEC 60601-1-2:2015) | Compliance met (implied by non-clinical summary) |
| Software Validation (IEC 62304:2006, FDA guidance) | "results of this testing conclude the software has met these requirements." |
| Biocompatibility of patient-contacting materials (ISO 10993-1:2009) | "confirmed to be biocompatible for their intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "bench testing" and "functional laboratory testing," which typically refers to testing of the device itself rather than human or image data. No patient or image test set is mentioned.
- Data Provenance: Not applicable, as no human or image data test set is described. The testing appears to be primarily laboratory-based device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No ground truth based on expert review of patient data is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring adjudication (e.g., image review) 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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device description and intended use (diathermy device) do not involve human readers interpreting images or data with or without AI assistance.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This document describes a physical medical device (diathermy) and its performance, not an AI algorithm. The software validation mentioned is for the device's operational software, not an AI component making diagnostic or treatment recommendations.
7. The type of ground truth used
- Type of Ground Truth: For the performance tests mentioned (temperature maintenance, electrical safety, EMC, software validation, biocompatibility), the "ground truth" would be established by engineering specifications, relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1), and internal performance targets.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not applicable, as no training set for an AI/ML algorithm is mentioned.
§ 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.