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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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Renuvion® Micro Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.

The Renuvion® Micro Handpiece is compatible with the Apyx One Console Generator, owned by Apyx Medical.

The Renuvion® Micro System with all components and accessories is show in the picture below. The system is comprised of a compatible electrosurgical generator (Apyx One Console), a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a digital gas regulator, grounding pad and optional footswitch.

The Renuvion® Micro handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with the Apyx One Console Electrosurgical Generator for the percutaneous delivery of radiofrequency and helium plasma energy to soft tissue. When connected to the Apyx One Generator, the device operates at an adjustable power of up to 12 W (expressed as 0 - 30% where 30% is 12 W) and an adjustable helium gas flow of 1 -1.5 L/Min. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue coagulation/contraction.

The handpiece has a non-extendable electrode to generate helium plasma. The handpiece features a low-profile shaft that is 10cm in length. The distal end of the shaft and tip has a 2mm outer diameter that tapers down to 1.5mm for the remaining length of the shaft.

The Renuvion® Micro Handpiece is cleared based on demonstrating substantial equivalence to a predicate device, the Renuvion® APR Handpiece (K223262 and K230272). This type of submission (510(k)) focuses on comparing a new device to an already legally marketed device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" are primarily based on demonstrating that the new device is as safe and effective as the predicate device by showing similar technological characteristics and performance.

Here's a breakdown of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a separate section with specific numerical targets. Instead, it presents various tests performed and states whether the device "met requirements" or demonstrated equivalent/lesser effects compared to the predicate. The overall acceptance criterion is demonstrating that the Renuvion® Micro Handpiece is as safe and effective as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify numerical sample sizes for the bench, electrical safety, biocompatibility, or ex-vivo tests. It states that tests were conducted according to protocols.
• Data Provenance:
  • All summarized tests appear to be pre-clinical/bench-top studies and ex-vivo (tissue) tests conducted by the manufacturer, Apyx Medical Corporation.
  • The "Ex-vivo tissue testing" section implies that animal or cadaveric tissue was used, but the specific origin (e.g., species, country) is not mentioned.
  • There is no mention of human subjects or clinical data in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Since these are primarily bench and ex-vivo tests for a 510(k) submission, the "ground truth" is established by engineering and scientific measurements/observations against predefined specifications and industry standards.
• The document does not mention the involvement of external medical experts (e.g., radiologists) for establishing ground truth in these specific tests. The experts involved would likely be engineers, scientists, and quality assurance personnel from Apyx Medical performing the tests and comparing results to established criteria. There is no mention of "ground truth" in the context of clinical interpretation, as clinical studies were not performed.

4. Adjudication Method for the Test Set:

• Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation by multiple readers.
• Given that this submission relies on bench and ex-vivo testing, such adjudication methods are not applicable and are not mentioned in the document. Performance is measured against physical or biological criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." (Section 6: Clinical Studies).
• Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is not an AI-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable as the Renuvion® Micro Handpiece is an electrosurgical device, not an algorithm or AI-based system. It does not perform diagnostic tasks independently.

7. The Type of Ground Truth Used:

• For the bench and ex-vivo tests, the "ground truth" is based on:
  • Defined engineering specifications (e.g., mechanical functionality, system compatibility, electrical safety, packaging integrity).
  • Biological responses to known stimuli (e.g., non-cytotoxic, no sensitization reaction for biocompatibility tests).
  • Physical measurements and comparisons (e.g., thermal effect and tissue temperature measurements in ex-vivo tissue).
• The ground truth is established by the test protocols against established standards and internal design requirements, often compared to the performance of the predicate device.
• No pathology or outcomes data is mentioned as forming the ground truth for this set of studies.

8. The Sample Size for the Training Set:

• This question is not applicable for this device. Training sets are relevant for machine learning or AI-based devices. The Renuvion® Micro Handpiece is a physical surgical tool, and its development involves engineering design and testing, not algorithm training.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable as there is no training set for this device.

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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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The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. 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. The POTENZA has two operating modes: monopolar mode and bipolar mode.

The provided text describes the 510(k) premarket notification for the POTENZA device, specifically for the addition of four new electrode tips. The document details the performance data collected to demonstrate that the expanded device meets acceptance criteria and is substantially equivalent to its predicate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides tables of acceptance criteria and results for biocompatibility and sterilization residual testing. Other tests mention conformance to specified standards as their acceptance criteria.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state sample sizes for specific tests with numerical values like "N=X". For biocompatibility testing, it mentions "the electrode tips were tested as shown in Table 1," implying a sufficient sample was used for each test type according to the standard. Similarly, for bench testing, it states "Jeisys conducted bench testing to assure that the four new electrode pins operate safely and within the predefined design specifications," suggesting testing was performed on the new electrode tips.

The data provenance is from Jeisys Medical, Inc. (South Korea), as the submitter is based in Seoul, Korea. The studies are retrospective in the sense that they are conducted by the manufacturer for the specific purpose of demonstrating substantial equivalence to a predicate device, rather than actively collecting new clinical data on human patients in a prospective manner.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The studies described are primarily in vitro (biocompatibility, sterilization), in silico (software), and benchtop engineering tests, not studies that require expert-established ground truth from clinical images or patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving expert review of data (e.g., medical images). The tests described here are technical performance tests, not clinical evaluations requiring adjudication.

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 provided and not applicable. The device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable. The POTENZA is a hardware device with associated software, not a standalone algorithm/AI for diagnostic interpretation. Its performance is evaluated through its physical and electrical characteristics as well as its software's functionality. The bench testing and electrical safety tests demonstrate the device's standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the various tests is based on recognized consensus standards and predefined design specifications. For example:

• Biocompatibility: Standards like ISO 10993 and USP provide the "ground truth" for acceptable biological response.
• Electrical Safety & EMC: IEC 60601 series standards define the ground truth for safe electrical operation and electromagnetic compatibility.
• Software Verification: FDA guidance provides the framework for acceptable software validation.
• Bench Testing: The device's own predefined design specifications, safety mechanisms, and performance ranges (e.g., needle depth range of the predicate device) serve as the ground truth.
• Sterilization & Shelf-life: ISO standards (e.g., 10993-7, 11135), ASTM standards (e.g., F1980-16, F1929-15), and USP standards provide the ground truth for acceptable sterilization residuals, sterility assurance level, and packaging integrity.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The described tests are for device validation and verification, not for training an AI or machine learning model.

9. How the Ground Truth for the Training Set was Established

This information is not provided and not applicable. No training set for an AI/ML model is mentioned or relevant to this device's submission.

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