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These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.

The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only.

This document is a 510(k) Pre-market Notification for Laparoscopic Hollow Electrodes. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All the test results demonstrate the performance of New Deantronics Laparoscopic Hollow Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses." However, specific quantitative acceptance criteria or detailed reported performance values for each test are not explicitly provided in this document. The document broadly states that the device "passed all" relevant tests and "met the requirements."

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

The document does not specify the sample sizes used for any of the bench, electrical safety, EMC, shelf-life, or biocompatibility tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. These were all bench tests conducted by New Deantronics, presumably in their facilities in Taiwan, R.O.C., as per the sponsor information.

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

This information is not applicable as the evaluation involved physical, electrical, and material testing of a medical device, not a diagnostic or prognostic system requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The tests performed are objective measurements against predefined standards or specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (electrosurgical electrodes). The device is a tool used by a surgeon, not a diagnostic aid that would improve human reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)

This is not applicable as the device is a physical electrosurgical electrode and does not involve any algorithms or AI for its function.

7. Type of Ground Truth Used

The "ground truth" for the tests performed was established through objective engineering and material science standards and specifications.

• Bench Testing: Internal requirements, FDA guidance (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery).
• Electrical Safety & EMC: International standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
• Shelf-Life Testing: FDA guidance and internal requirements.
• Biocompatibility Testing: ISO 10993-1 and FDA guidance.

8. Sample Size for the Training Set

This is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."

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

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

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The Valleylab Laparoscopic Handsets (models E2750, E2750T, E2751 and E2751T) and the Electrodes (models E2770 series, E2780 series, E2780R series and E2780R-ASP) are intended for use in those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable.

The device is not intended to be used in endoscopic surgical procedures.

The Valleylab Laparoscopic Handsets referenced above are sterile, disposable devices, capable of delivering either electrosurgical cutting or coagulation currents, as well as irrigation and suction. They are for single use only, and are not to be resterilized.

The Valleylab Laparoscopic Electrodes referenced above are sterile, disposable electrodes. The Electrodes are offered in two lengths, 28 cm and 36 cm., and are designed for use with a 5 mm trocar cannula, or larger trocar cannulas with appropriate 5 mm adapters. The Electrodes are for single use only, and are not to be resterilized.

The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it describes a traditional medical device (Valleylab Laparoscopic Handsets and Electrodes) and details its intended use, product description, and safety/performance characteristics related to biocompatibility and electrical testing.

Therefore, I cannot extract the requested information (such as reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies) as it is not present in the given text.

The text focuses on:

• Intended Use: Laparoscopic surgical procedures where electrosurgical current, irrigation, and suction are desired from a single handset.
• Product Description: Sterile, disposable handsets and electrodes for single use, capable of delivering electrosurgical cutting/coagulation, irrigation, and suction. Electrodes come in different lengths and are for use with 5mm (or larger) trocar cannulas.
• Safety and Performance (general statement): "Published studies indicate that laparoscopic and thoracoscopic electrosurgery is safe and effective in a variety of surgical procedures." (This is a general statement, not specific to a study on this particular device's performance against defined acceptance criteria).
• Biocompatibility Testing: Materials selected demonstrated appropriate biocompatibility, and patient contact components were tested according to USP Class V or ISO Standard 10993-1.
• Electrical Testing:
  • High voltage breakdown: Handsets and electrodes passed testing at a minimum of 5200 volts RMS (60 Hz) for 60 seconds, exceeding AAMI HF18-1986 requirement of 3000 volts RMS.
  • High Frequency Leakage Current: Electrodes confirmed to be well below the acceptable limit of 150mA (IEC Standard 601-2-2).
  • High Frequency Breakdown: Designed to meet IEC Standard 601-2-2 and confirmed during product qualification.

None of this information pertains to an AI/ML device or its performance against specific clinical or analytical acceptance criteria.

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