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

This device is a Fractional RF Surgical Unit with Sterile Micro Needle, which is composed of the main device (generator and user interface display, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. It is designed for applying radiofrequency therapy with microneedles, which coagulates skin tissue using 1 MHz or 2 MHz radiofrequency energy delivered from the generator to the microneedles. A Bipolar Handpiece suction filter is also available for use to remove unwanted debris from the skin application site and safeguarding the equipment by preventing foreign substances from entering during use.

The provided text is a 510(k) Summary for a medical device (CWM-930S Radio Frequency Therapy System). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on studies involving AI or human reader performance.

Therefore, the document does not contain the information requested regarding acceptance criteria for AI device performance, sample size for test sets (in the context of AI models), data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI models, training set sample size, or how ground truth for training was established.

The "Performance Testing" section does mention some non-clinical performance tests for the CWM-930S device itself, but these are not related to AI model performance or human reader studies. Specifically, it mentions:

• Non-Clinical Test Summary [21 CFR 807.92(b)(1)]:
  • Electrical Safety, Electromagnetic Compatibility Testing: Compliance with IEC 60601 series standards.
  • Software Validation: CWM-930S has a MODERATE level of concern software that was designed, developed, verified, and validated according to FDA guidance.
  • Biocompatibility: Tested parts include the Cap, Electrode (needle and coating) made of SUS, and Neutral Electrode composed of Hydrogel, Cloth, Aluminum Film, Transparent Film, and Loctite Dura-Tak 129a. All showed biocompatibility for intact skin contact for limited duration (

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For use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Retraction, CWM-910T and APOLEX Tite are RF electrosurgical system. These are identical except for model designation. The RF electrosurgical system consists of an electrosurgical device (ESU), 3 types of detachable handpieces (mono-polar active electrode), a grounding plate (neutral electrode) and a foot switch. The hand piece consists of a hand grip and an electrode. There are 3types of mono-polar electrode depend on diameter and length. The electrosurgical device generates 480KHz RF current. RF output energy (Max. 50W) is delivered through a mono-polar active electrode and returned through the grounding plate (neutral electrode).

The provided document, an FDA 510(k) K222709 submission summary, describes the design, testing, and comparison of the Retraction, CWM-910T, APOLEX Tite RF electrosurgical system to a predicate device. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/ML-driven medical device study.

The document focuses on demonstrating substantial equivalence for an electrosurgical device, primarily through bench testing, electrical safety, biocompatibility, and reprocessing validation. It's a traditional medical device submission, not one for an AI-enabled diagnostic or therapeutic device that would involve performance metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot create the requested table or answer the specific questions related to AI/ML study components (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance, training set details) because this information is not present in the provided text.

The document does mention:

• Device Type: RF Electrosurgical System (not AI/ML)
• Purpose: Electrocoagulation and hemostasis in dermatological and general surgical procedures.
• Bench Testing: Conducted for RF output power and a comparison test with the predicate device, including graphical display of output waveform and power output over a range of loads.
• Animal Study: A "mini pig" thermal effect study was conducted for safety assessment, comparing the subject device and predicate device. Evaluated thermal imaging area analysis, maximum temperature, and time to reach basal temperature.
• Software: Firmware verification and validation according to FDA guidance and IEC 62304. This is firmware, not an AI algorithm.
• Electrical Safety & EMC: Tested against IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2.
• Biocompatibility: Tested against ISO 10993 series.
• Reprocessing: Validated according to FDA reprocessing guidance.

Without the context of an AI-driven device, the questions regarding acceptance criteria for AI performance, test set and training set details, ground truth establishment by experts, and MRMC studies are not applicable to the provided document.

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