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510(k) Data Aggregation
(26 days)
Electrodes Handpieces (VCT, RFTV, BMDT) are sterile, single-use electrosurgical electordes intended to be use in conjunction with with compatible radio frequency generator, mainly Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
Electrodes Handpieces (VCT, RFTV, BMDT) consist of electrode tip, insulation part, handle.
Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (VCT, RFTV, BMDT), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
This document describes a 510(k) premarket notification for Electrode Handpieces (VCT, RFTV, BMDT) and does not contain information about the acceptance criteria or a study proving that an AI/ML device meets those criteria. The provided text is for a traditional medical device (electrosurgical electrodes) and focuses on substantial equivalence to a predicate device through non-clinical performance data.
Therefore, I cannot provide a response with the requested information about acceptance criteria and a study for an AI/ML device from this document.
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(122 days)
The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Mygen M-3004 RF System consists of a microprocessor based RF generator, a cooling pump and tubing, electrodes, and ground pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. Mygen M-3004 RF System generator is capable of delivering up to 200 waits (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature.
The radiofrequency (RF) energy, which is delivered to an electrode, makes frictional heat for coagulation and ablation on diseased tissue by ionic agitation. The patient can receive safe therapy as leakage current is extremely low. Mygen M-3004 continually measures and displays RF output power, tissue impedance, and elapsed time of RF delivery. Tissue temperature is measured by the thermocouple embedded in the electrode tip and is displayed on the touch screen. This equipment automatically adjusts the output to maximize the delivery of high-frequency energy and displays the measured temperature from the treatment site during high-frequency emission.
Mygen M-3004 automatically adjusts the output to optimize radiofrequency output and displays the measured temperature from the treatment area while delivering radiofrequency energy.
This is a 510(k) summary for a medical device called the "Mygen M-3004 RF System," an electrosurgical cutting and coagulation device. The document primarily focuses on establishing substantial equivalence to a predicate device, not on clinical performance or diagnostic accuracy. Therefore, the information requested in your questions, particularly regarding acceptance criteria for diagnostic accuracy, expert review, and training/test set details, is largely not present in this type of submission.
Here's an breakdown of the available information based on your questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria for diagnostic accuracy or performance metrics like sensitivity, specificity, or AUC. Instead, it details performance tests conducted to ensure the device functions as intended and is safe. The "acceptance criteria" here are implicit in the successful completion of these engineering and safety tests, demonstrating compliance with relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Performance | |
| Accuracy of Output | Tests conducted; fulfilled |
| Accuracy of Energy Transfer | Tests conducted; fulfilled |
| Active Electrode Resistor | Tests conducted; fulfilled |
| High Frequency and Mains Frequency Dielectric Strength of Active Electrode | Tests conducted; fulfilled |
| Accuracy of Tip Temperature | Tests conducted; fulfilled |
| High Frequency Leakage of Active Electrode | Tests conducted; fulfilled |
| Biocompatibility | |
| Cytotoxicity | Non-cytotoxic |
| Delayed Hypersensitivity | Non-sensitizer, non-allergenic |
| Intracutaneous Reactivity | Non-skin irritant |
| Pyrogenicity | Free of pyrogens |
| Acute Systemic Toxicity | Not toxic |
| Endotoxin Level |
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(243 days)
Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.
Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).
Electrodes Handpieces (BT, JET) consist of electrode tip, insulation part, handle.
Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (BT, JET), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
This document (K193355/S002) is not for an AI/ML medical device, but rather for "Electrode Handpieces (BT, JET)" which are electrosurgical electrodes used for coagulation and ablation of soft tissue. Therefore, the questions related to AI/ML device acceptance criteria, study details, and human-in-the-loop performance are not applicable.
However, I can extract the acceptance criteria and study details that were performed for this specific medical device from the provided text.
Here's a breakdown of the information found, specifically addressing the device's performance data and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO10993-1;2009) | Patient contact components and materials must meet ISO10993-1;2009 standards. | Tested and validated according to ISO10993-1;2009. Patient contact components and materials are identical to the predicate device. |
| Shelf-Life Testing | Packaging seal strength, packaging dye penetration, appearance, conduction, and sterility must meet acceptance criteria (ASTM F 1980 Accelerated Aging). | All testing results passed the acceptance criteria for packaging seal strength, packaging dye penetration, appearance, conduction, and sterility, in accordance with ASTM F 1980 Accelerated Aging method for a valid shelf life. |
| Medical Electrical Equipment Safety (IEC 60601-1) | General Requirements for basic safety and essential performance must be fulfilled. | The requirements of specified standards (IEC 60601-1) were fulfilled. |
| Electromagnetic Compatibility (IEC 60601-1-2) | General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility) must be fulfilled. | The requirements of specified standards (IEC 60601-1-2) were fulfilled. |
| High Frequency Surgical Equipment Safety (IEC 60601-2-2:2009) | Particular requirements for the basic safety and essential performance must be fulfilled. | The requirements of specified standards (IEC 60601-2-2:2009) were fulfilled. |
| Temperature Sensor Accuracy (of V-1000 generator) | Measured values by the temperature sensor of V-1000 and the temperature calibrator must be within ±3°. | The test results confirmed that the values measured by the temperature sensor of V-1000 and the temperature calibrator were within the acceptance criteria (±3°). Tested in multiple power modes, three times for each power setting. |
| Bacterial Endotoxin Concentration (LAL Test) | Bacterial endotoxin concentration should be |
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(239 days)
The Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Electrosurgical, cutting & coagulation device & accessories
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Mygen V-1000 RF System" does not contain any information regarding acceptance criteria, study details (like sample size, ground truth, expert qualifications, or MRMC studies), or performance metrics beyond the simple statement of "substantial equivalence" to a predicate device.
The document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements, but it does not delve into the specific technical studies or performance data typically found in a clinical study report or a detailed 510(k) summary (which might be a separate, more extensive document).
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.
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