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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.

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The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Fiber Optic Delivery Systems and Handpieces are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. Similarly, the predicate devices are also components of delivery systems designed to deliver laser radiation to a specified point. FiberTech's Fiber Optic Delivery System's fiber optical Handpiece and Tip has a similar material composition as its predicate devices. Third, the Fiber Optic Delivery System is available in sizes between 200 micron and 1000 micron. Ceramoptec's and Coherent Laser Delivery Systems is available also in sizes ranging from 200 micron to 1000 micron. Fourth, the reusable and the disposable Fiber Optic Delivery Systems are available in the same tip shapes and handpiece configurations. Further, both the reusable and the disposable devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used. Finally, the reusable Fiber Optic Delivery System can be reused only once the optical fiber tip is properly cleaned, inspected, stripped and cleaved.

The provided text is a 510(k) summary for the FiberTech's USA Fiber Optic Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the standard for 510(k) clearances. The "Performance Data" section primarily refers to certifications, not clinical performance metrics.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because the provided document does not contain that type of information. It's a regulatory document for a physical medical device, not an AI/ML software as a medical device.

Here's a breakdown of why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "no new questions of safety and effectiveness raised by the introduction of this devices" based on similarity to predicates, rather than quantifiable performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. Performance is established through comparison to predicate devices and existing certifications, not through a separate clinical test set in the traditional sense for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Section 2) mentions:

• CE marking (Medical Device Directive 95.E.02)
• Certification under EN ISO 19407:2009
• Certification for Quality EN ISO 9001:2000

These are quality management system and regulatory compliance certifications, not direct performance metrics of the device itself (like accuracy of an AI algorithm). The basis for clearance is substantial equivalence to the predicate devices listed (Ceramoptec's Fiber Optic Delivery Sytems, InnovaQuartz Fiber Optic Delivery System, Laser Peripherals Fiber Optic Delivery System, Trymedyne Inc., Fiber Optic Delivery System). The argument for substantial equivalence is based on:

• Intended Use
• Technological Characteristics (material composition, available sizes, tip shapes, handpiece configurations, sterile packaging, connector types, reusability)

In summary, this document is a 510(k) submission for a physical medical device. It relies on demonstrating similarity to already cleared devices and adherence to manufacturing and quality standards, rather than presenting a performance study with acceptance criteria and ground truth, as would be expected for an AI/ML-based medical device.

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