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Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H Laser Fiber K022544.

The provided text, K121938, describes Dornier's Medilas H RFID Laser Fibers, which is a modification of an already cleared device. This submission is a Special 510(k) notice, indicating that the device has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate devices, with only minor differences that do not raise new questions of safety or effectiveness.

Therefore, the submission primarily focuses on demonstrating that the modified device performs as safely and effectively as the predicate devices. This type of submission does not typically involve the extensive clinical studies with human subjects, ground truth establishment, or multi-reader, multi-case studies that would be associated with entirely new medical devices or software algorithms.

Based on the provided document, here is the information requested, with "N/A" for criteria not addressed in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Performance data demonstrates that the Dornier Medilas H RFID Laser Fibers are as safe and effective as the listed predicates." Specific quantitative acceptance criteria and detailed performance metrics are not typically required or presented in this type of 510(k) summary for accessory modifications. The "performance data" likely refers to bench testing to ensure the fiber's physical and functional properties (e.g., power transmission, durability, RFID functionality) are comparable to the predicate.

2. Sample size used for the test set and the data provenance: N/A (No human subject test set is described for this type of submission.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth established by experts is not applicable to this type of device modification submission.)

4. Adjudication method for the test set: N/A (No human subject test set or adjudication process is described.)

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: N/A (This is not an AI device, and no MRMC study was conducted.)

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (This is a physical medical device accessory, not an algorithm.)

7. The type of ground truth used: N/A (Not applicable. The equivalence is based on engineering design, bench testing, and comparison to existing predicate devices, not clinical ground truth in the context of diagnostic accuracy.)

8. The sample size for the training set: N/A (Not applicable, as this is a physical device accessory, not a machine learning algorithm.)

9. How the ground truth for the training set was established: N/A (Not applicable.)

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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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