Search Results

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers. The laser system base contains the switching elements and interfaces, the display unit, the fiber connection point, components inside the laser system, and software. For a safe operation, essential functions and components are monitored automatically. The MegaPulse Laser system is designed with automated fiber recognition to ensure only permissible parameters are used. A warning message appears on the touch screen monitor and is accompanied by a signal should a fault or error occur. The MegaPulse Laser Fibers are intended to be used in with MegaPulse Laser System to deliver laser energy. The laser fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to provide access to the surgical procedure site. The laser fiber works on the principle of internal reflection. Laser energy is focused into the fiber at the proximal end and it travels the length of the fiber by means of total reflection. The fiber contains the laser beam and channels the laser energy from the proximal end of the fiber to its distal end. The laser fibers are single-use sterile packaged. They are similar if not equivalent in design and performance to other legally marketed laser fibers with an integrated fiber identification system designed to work only with the MegaPulse laser system base.

This device is a MegaPulse Laser System and its associated MegaPulse Laser Fibers, intended for various surgical procedures.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or numerical performance metrics in the way one might expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied to be the general safety and effectiveness standards met by the predicate devices and validated through bench testing.

2. Sample Size for the Test Set and Data Provenance

• Test set sample size: Not applicable. This submission relies on bench testing and comparison to predicate devices, not on a clinical test set.
• Data provenance: Not applicable. The "study" is a bench validation of specifications.

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

• Number of experts: Not applicable. Ground truth for a clinical test set was not established as there was no clinical study. The device's performance was evaluated against engineering specifications and comparison to predicate devices.
• Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No, an MRMC comparative effectiveness study was not done. This being a laser surgical instrument, such a study is not typically relevant for its 510(k) clearance process without a specific AI component for interpretation or diagnosis.
• Effect size: Not applicable.

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

• Standalone study: Not applicable. The device is a surgical instrument. "Algorithm-only" performance is not relevant in the context of this device without specific AI features for diagnosis or entirely autonomous operation, which are not described. The software validation mentioned focuses on control and operation of the laser system, not on diagnostic or interpretive algorithms.

7. The Type of Ground Truth Used

• Type of ground truth: The "ground truth" for this submission is implicitly based on engineering specifications, regulatory standards, and the established safety and effectiveness profiles of the predicate devices. For example, the laser's power output or wavelength accuracy would be verified against its design specifications, and its overall performance would be considered "acceptable" if it mirrored the safe and effective operation of already-approved predicate devices.

8. Sample Size for the Training Set

• Training set sample size: Not applicable. This device is a traditional medical device (laser system) and not an AI/ML product developed using a training set in the typical sense.

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

• Ground truth for training set: Not applicable. As an AI/ML training set was not used, there was no ground truth to establish for such a set.

Ask a specific question about this device