(179 days)
This device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The DENSITY, DENZA, DENSITY Noir generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coagulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The devices are an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.
It consists of the following components:
- Electrosurgical Unit - Main body
- Handpiece
- electrode tips
- Neutral electrode pad and neutral electrode pad cable, cleared under K201685
- Foot switch
- Power cord
This document is a 510(k) clearance letter for an electrosurgical device, not a study report for an AI device. As such, most of the requested information regarding AI device acceptance criteria, study details, and performance metrics (like effect sizes for AI assistance, standalone performance, training sets, etc.) is not present in the provided text.
The device described, "DENSITY; DENZA; DENSITY Noir," is an electrosurgical cutting and coagulation device. The clearance is based on substantial equivalence to a predicate device (K230663), implying that its performance is expected to be similar to legally marketed devices based on established standards and non-clinical testing.
Here's a breakdown of the information that can be extracted from the provided text, along with an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance that would be found in a typical AI device study (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical performance testing.
Acceptance Criteria (Implied by Substantial Equivalence and Standards Adherence):
| Criterion Type | Description | Reported Device Performance/Verification Method |
|---|---|---|
| Safety & Performance Standards | Compliance with recognized national and international safety and performance standards for electrosurgical devices. | Evaluated in accordance with: |
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 (Basic safety and essential performance)
- IEC 60601-1-2:2014 (Electromagnetic disturbances)
- IEC 60601-2-2 (HF surgical equipment particular requirements)
- IEC 60601-1-6:2013 (Usability) |
| Software | Software verified and validated to a moderate level of concern, adhering to software lifecycle processes. | Evaluated according to IEC 62304:2006. |
| Usability/Human Factors | Application of usability engineering to medical devices. | Evaluated in accordance with IEC 62366:2008 based on Human Factor Engineering. |
| Biocompatibility | Materials in contact with patients are biocompatible. | Documented in reference to ISO 10993-1:2009, ISO 10993-5:2009, and 10993-10:2010. |
| Bench Testing Performance | Device operates safely and within predefined design specifications, demonstrating intended function for electrocoagulation and hemostasis. | Bench testing conducted to assure safe operation and adherence to design specifications. |
| Ex Vivo Thermal Testing | Performance in tissue coagulation and hemostasis, particularly regarding thermal effects. | Ex Vivo testing conducted on three types of tissue under GLP Thermal testing in accordance with FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery". |
| Risk Management | Risks identified, analyzed, and controlled. | Risk analysis conducted based on ISO 14971:2019. |
| Substantial Equivalence | Device is as safe and effective as a legally marketed predicate device, with no new questions of safety or effectiveness raised by differences. | Compared to predicate device K230663. All key parameters (output energy type, user interface, operating frequency, max power, electrode tip types, temperature range, impedance, coolant solution, communication) were found to be substantially equivalent. Minor differences in electrode tip styles and number of tips were deemed not to affect performance or safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as this letter describes non-clinical testing for an electrosurgical device, not a clinical study or AI performance evaluation. The "test set" here refers to the materials and conditions used for bench and ex-vivo testing. The document states:
- "Ex Vivo testing conducted on three types of tissue". No specific sample size (e.g., number of tissue samples) or provenance is mentioned beyond "under GLP Thermal testing."
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)
This information is not applicable/not provided. Ground truth for an AI device is typically established by expert interpretation of medical images or data. For an electrosurgical device, performance is evaluated against engineering specifications, recognized safety standards, and physiological responses during ex-vivo testing, not by expert interpretation generating a "ground truth" in the same sense as an AI diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or labeling, especially for AI algorithm ground truth establishment. This is not relevant for the type of non-clinical testing 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
This information is not applicable/not provided. An MRMC study is relevant for evaluating the impact of AI assistance on human performance, typically in diagnostic imaging. The device in question is a standalone electrosurgical instrument and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a manual electrosurgical instrument, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing:
- Bench testing: Ground truth is defined by the device's technical specifications and engineering design (e.g., power output within tolerance, correct operating frequency).
- Ex Vivo testing: Ground truth would be the expected physiological effect (e.g., desired thermal coagulation) confirmed through histological examination or other scientific methods in the tissue samples. This is implied by "Ex Vivo testing conducted... under GLP Thermal testing."
8. The sample size for the training set
This information is not applicable/not provided. This device is an electrosurgical instrument, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
§ 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.