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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 coagulation 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,
• o ENT.
• General Surgery.

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K152591) to include a rounded, ball tip, distal end. The fiber core and cladding for the subject device are made from silica, which is same material used in the predicate device. Additionally, the fiber is manufactured and tested in the identical fashion as the company's predicate device and functions in an equivalent manner.

The medical device described in the document is the "Dornier Medilas H RFID Gentle Flex Laser Fiber," an accessory for the Dornier Medilas H Holmium Laser. This device is a modification of a previously cleared device (K152591), with the primary change being the addition of a rounded, ball-tip distal end.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each functional performance test. The data provenance is also not explicitly stated in terms of country of origin, nor whether the studies were retrospective or prospective.

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

This information is not provided in the document. The performance tests appear to be engineering/technical evaluations rather than clinical studies requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or provided, as the tests described are functional performance tests rather than assessments requiring human adjudication of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned or performed. The studies were non-clinical functional performance tests comparing the modified device to a predicate device.

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

This question is not applicable as the device is a medical accessory (laser fiber) and not an AI or algorithm-based device.

7. The Type of Ground Truth Used

For the functional performance tests, the "ground truth" was established by comparing the performance characteristics of the modified (subject) device against the established performance characteristics of the predicate device (Dornier Medilas H RFID Laser Fiber - K1525591). These are objective measurements related to physical and optical properties.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI or algorithm-based device that requires a training set.

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

This question is not applicable as the device is not an AI or algorithm-based device.

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Dornier's Medilas H RFID Reusable 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 coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, 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 basic technological characteristics of the subject device are:

• Use of a Silica-glass Fiber to transmit the laser energy; .
• Use of a plastic SMA 905 connector for connection to the laser; .
• t Other materials used in the manufacturing of the product: Natural Quartz Ferrule; Heat Shrink tubing; and SMA connector strain relief boot;
• . All fibers are 3 meters (nominal) in length;
• The fibers are sold in core diameter sizes of 272, 365, 550 and 940 microns. .
  The basic principal of operation of the Laser Fibers is to transmit laser energy when connected to a Holmium Laser. The Laser Fibers that are the subject of this submission are identical to the predicate fibers (K121938) with the exception of being able to be reused.

This is a 510(k) premarket notification for a reusable medical device, specifically laser fibers. The submission focuses on demonstrating substantial equivalence to previously cleared devices through performance data, largely related to the reprocessing capabilities and the integrity of the fiber after multiple uses.

Here's a breakdown of the requested information based on the provided text, with an important caveat: This document describes a medical device, not an AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or relevant to this type of regulatory submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of a medical device's performance testing for reusability and safety.

Acceptance Criteria and Device Performance

Study Details (or why they are not applicable for this device type)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not explicitly stated in the provided text. For a device like this, testing would typically involve a certain number of fiber samples subjected to multiple reprocessing cycles. The documentation does not specify these numbers or the origin of the test data.
   • Data Provenance: Not specified. Testing for reusability is typically conducted in a laboratory setting.
   • Retrospective or Prospective: Not applicable in the context of this device's performance testing. This would be controlled lab testing or simulated-use testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission describes a physical medical device (laser fiber) and its reusability, not a diagnostic or AI/ML algorithm that requires expert "ground truth" to evaluate its output. Evaluation would rely on objective physical, chemical, and functional performance metrics.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. See point 2.

4. 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:

   • Not applicable. This device is a laser fiber, not an AI/ML system. There are no "human readers" or "AI assistance" involved in its direct function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. The "ground truth" for reusable medical devices is typically established through recognized standards for cleaning, disinfection, sterilization, material compatibility, and functional performance testing (e.g., laser transmission efficiency, optical integrity, structural integrity, sterility assurance levels) after specified numbers of reprocessing cycles. The "performance data" mentioned would be derived from such objective measurements.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the AI/ML context.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

Summary for this specific device:

The regulatory approval for the Dornier Medilas H RFID Reusable Laser Fibers is based on demonstrating substantial equivalence to existing predicate devices (Dornier Medilas H RFID Laser Fiber K121938 and Dornier Medilas H Laser Fiber Cables K022544). The key modification is the addition of reprocessing instructions to allow for reusability. The "study" that proves the device meets acceptance criteria would be a series of performance tests confirming that the fibers maintain their safety and effectiveness (e.g., laser energy transmission, structural integrity, biocompatibility, and sterility after multiple reprocessing cycles) despite being reused and going through the specified cleaning and sterilization processes. The document states "Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates," implicitly confirming that these tests were conducted and the criteria met, though the specific details of these tests (like sample sizes, methods, and acceptance thresholds) are not provided in this specific excerpt.

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