(131 days)
SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.
The provided text describes a 510(k) summary for a medical device called "Secret RF". This document focuses on demonstrating substantial equivalence to a predicate device, "FRAXIS DUO_RF PART" (K160312), rather than providing detailed acceptance criteria and studies for independent device performance.
Therefore, many of the requested categories cannot be directly addressed from this document because it's a submission for substantial equivalence based on similar technology and intended use, not a clinical trial evaluating specific performance metrics against pre-defined acceptance criteria.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness for a 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated is that the device's technological characteristics and non-clinical test results are comparable or compliant with established standards, supporting its substantial equivalence to the predicate device.
| Acceptance Criteria (Implied from 510(k) review) | Reported Device Performance (as stated in document) |
|---|---|
| Safety and basic performance (Compliance with Electromedical Standards) | Fulfilled requirements of IEC 60601-1 (General Requirements for basic safety and essential performance). |
| Fulfilled requirements of IEC 60601-1-2 (Electromagnetic compatibility). | |
| Fulfilled requirements of IEC 60601-2-2:2009 (Particular requirements for high-frequency surgical equipment). | |
| Biocompatibility (for patient contact components) | Patient contact components and materials are tested and validated according to ISO10993-1:2009. |
| Materials are identical to the predicate device. | |
| Confirmation of tissue effects (Depth and zone of ablation/thermal damage) | In vivo animal testing using micropig models conducted to obtain histological data of values for depth and zone of ablation and thermal damage immediately post-treatment; 7 days post-treatment; and 14 days post-treatment. |
| Treatment performed at intensity (power) low, mid, high and micro-needling depth 1.0mm, 2.0mm, 3.0mm. (Results not explicitly quantified as meeting acceptance criteria in this summary). | |
| Substantial Equivalence (Comparison to Predicate Device) | No significant differences in HF electrosurgical application compared to FRAXIS DUO. |
| Same indication of use as predicate. | |
| Shares same technological characteristics as predicate. |
2. Sample size used for the test set and the data provenance
- Non-Clinical Testing (IEC Standards): Not applicable for "sample size" in the conventional sense of a clinical test set. These are engineering and electrical safety tests typically performed on a device unit.
- Animal Testing: Micropig models were used. The document does not specify the number of animals (sample size).
- Data Provenance: The document implies these tests were conducted by the manufacturer or accredited labs for the purpose of the 510(k) submission. No country of origin for the "test set" data is explicitly stated beyond the manufacturer being in Korea. The animal study results are not presented in a way that would indicate retrospective or prospective, but animal studies for regulatory submissions are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to the non-clinical and animal testing described. Ground truth in a clinical context (e.g., expert consensus on image interpretation) is not part of this 510(k) summary, which focuses on device safety and technical equivalence. The animal study generated histological data, which would typically be analyzed by veterinary pathologists, but this detail and the number of experts are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human readers, which is not described here.
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
Not applicable. This is a 510(k) submission for a non-AI electrosurgical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical tool, not an algorithm. Its performance is directly tied to its physical and electrical characteristics and how it interacts with tissue.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Non-Clinical Testing (IEC standards): "Ground truth" is compliance with the defined parameters and limits of the specific international standards (e.g., electrical safety, EMC).
- For Animal Testing: The ground truth for evaluating tissue effects was histological data obtained from micropig models, presumably interpreted by pathologists.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.