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The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable.

The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device.

RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and 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 RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue.

• Electrosurgical Unit Main body
• Five different handpieces
• Neutral electrode pad and neutral electrode pad cable, cleared under K092761
• Handpiece stands
• Foot switch
• Power cord

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (SILKRO), primarily focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to various safety and performance standards. It mentions non-clinical ex vivo animal testing for histological data but does not present this data as acceptance criteria or a study proving device performance against such criteria. The document explicitly states, "No clinical test was performed."

Therefore, I cannot extract the requested information.

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This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.

The provided text does not contain information about acceptance criteria and reported device performance from a clinical study for the SILKRO device. Instead, it focuses on non-clinical tests and a comparison of technological characteristics with predicate devices to demonstrate substantial equivalence for regulatory clearance.

Specifically, the document lists:

• Non-clinical tests submitted (Section 7): These are primarily related to electrical safety, electromagnetic compatibility, usability, risk management, software validation, and biocompatibility, conducted according to various IEC and ISO standards.
• Ex vivo animal testing (Section 7): This was conducted to evaluate the thermal effect of the handpieces on tissue, observing depth and zone of coagulation and thermal damage.
• Biocompatibility testing (Section 8): Confirmed that materials met biocompatibility requirements for skin contact, following ISO 10993 standards.
• Sterilization and shelf-life testing (Section 9): Demonstrated a sterility assurance level and a three-year shelf-life through accelerated aging tests.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document's conclusion (Section 11) states that "Results of performance testing demonstrated substantial equivalence of the subject device to the predicate," but it refers to the non-clinical tests mentioned earlier, not a clinical study involving human patients or a complex diagnostic performance evaluation.

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