(270 days)
The truSculpt RF energy 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 truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
The truSculpt device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.
The provided text is a 510(k) summary for the truSculpt device. It focuses on establishing substantial equivalence to a predicate device based on technological characteristics and safety standards. It explicitly states "Results of Clinical Study: None", which means the document does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the format you've outlined, as that data is not present in the provided document.
Here's a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: No clinical acceptance criteria or performance metrics are reported.
- Sample sized used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical performance is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set.
- 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: Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical efficacy data is presented.
- The sample size for the training set: Not applicable as no machine learning model or training set is discussed.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Establishing substantial equivalence to a predicate device (Cutera truSculpt RF Device K122389).
- Listing safety requirements (IEC 60601-1-2).
- Software verification and validation testing (truSculpt Software Verification and Validation Testing Report (V0005 rN)).
- Comparing technological features with the predicate device.
The "Results of Clinical Study: None" statement is key here, indicating that this submission does not include data from a clinical efficacy study.
§ 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.