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The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi.

The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.

The EndoBeam™ Holmium Laser Fibers are free-beam delivery devices that transmit laser energy in a forward direction. The devices are either 2.5 meters (8.2 ft.) or 3.0 meters (9.8 ft) in length and are terminated with a laser specific connector on the proximal end. These delivery systems are capable of delivering Ho:YAG (2140nm) and Nd:YAG (1064nm). The devices are either single use or reusable and are supplied Ethylene Oxide (EtO) sterilized.

The Bard Holmium series of laser fibers are fiber optic laser energy delivery devices consisting of an SMA 905 connector, strain relief, and a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The fibers are further equipped with a polished, flat output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.

The line of reusable laser fibers will feature a protective sheath outside of the jacketed fiber and extending from the strain relief to the midpoint of the fiber length.

This document describes the 510(k) premarket notification for the "EndoBeam™ Holmium Laser Fibers" (K120924/K120926). The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML-based device requiring detailed performance metrics against a defined ground truth derived from expert consensus or pathology. Therefore, many of the requested fields are not applicable in this context.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The submission focuses on demonstrating substantial equivalence by showing that the EndoBeam™ Holmium Laser Fibers have the same technological characteristics and intended use as predicate devices, and that nonclinical performance testing confirms their safety and effectiveness. The acceptance criteria are implicitly met by successful completion of these nonclinical tests and by showing equivalence to legally marketed devices.

Regarding the other requested information:

This 510(k) submission is for a physical medical device (holmium laser fibers) and does not involve AI or algorithms that would require a test set, ground truth established by experts, or training data in the typical sense of AI/ML performance evaluation. Therefore, the following points are not applicable to this submission.

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

• Not Applicable: This filing does not describe a software or AI/ML device that uses a test set of data for performance evaluation. The "performance data" refers to nonclinical functional and biocompatibility testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: There is no "ground truth" establishment by experts in the context of an AI/ML system for this type of device submission.

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

• Not Applicable: No test set or expert adjudication is described for this device.

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

• Not Applicable: This is a physical laser fiber, not an AI-assisted diagnostic or treatment system.

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

• Not Applicable: This is a physical medical device.

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

• Not Applicable: Ground truth for AI/ML performance is not relevant here. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., ISO 10993-1:2009, IEC 61754-22) and by demonstrating equivalence to predicate devices that have prior regulatory clearance and established safety records.

8. The sample size for the training set

• Not Applicable: No training set is involved.

9. How the ground truth for the training set was established

• Not Applicable: No training set with ground truth is involved.

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