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The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope.

The intended use and clinical applications are described in the User Manual of the corresponding Laser.

SLI Laser Probes are medical optical fibers to transfer the radiation emitted by a medical laser to its target at or in the patient. The laser beam conducted to pathological tissue destroys it thermally. The probes do not change the physical properties of the laser beam emitted by the laser device. The devices are sold sterile (EO) and are ready to use.

Fiber core and cladding for the applied device are made of silica glass, coated with a hard fluoropolymer. Fiber jacket consists of highly biocompatible polymers such as ETFE. The medical device is offered in various core diameters. Laser light is coupled into the fiber via a standard SMA connector. The cannula of the endoprobes is made of 1.4301 stainless steel.

This document is a 510(k) premarket notification for the SLI-Laser Fibers. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The information provided is about the device itself, its intended use, technological characteristics, and non-clinical testing performed.

The document does not contain information about acceptance criteria or a study that specifically proves the device meets (or fails to meet) acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone performance).

Instead, the submission relies on demonstrating substantial equivalence to predicate devices and provides a summary of non-clinical bench testing and biocompatibility testing. The "Performance Data" section explicitly states, "Since the performance of the SLI-Laser fibers is well established and documented on soft tissue, no performance testing is being specifically included in this submission. Validation reports can be submitted on demand."

Therefore, I cannot fill in the requested table and answer the specific questions about acceptance criteria and performance studies because that information is not present in the provided text.

Based on the document, I can provide the following:

Device Description and Claims:

• Device Name: SLI-Laser Fibers, including Endoprobes, Bare Fibers, Dental Bare Fibers, Lateral Firing Fibers, SLI Endoprobe, SLI Dent Bare Fiber, SLI Ho Bare Fiber, SLI Hcs Bare Fiber, SLI Lateral Firing Fiber, SLI Lateral Contact Fiber.
• Intended Use/Indications for Use: The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope.
• Technological Characteristics: Optical fibers to transfer radiation from a medical laser to a target. They do not change the physical properties of the laser beam. Supplied sterile (EO) and ready to use. Fiber core and cladding are silica glass, coated with hard fluoropolymer. Fiber jacket is made of biocompatible polymers like ETFE. Laser light is coupled via a standard SMA connector. Cannula of endoprobes is made of 1.4301 stainless steel.
• Predicates:
  • FIBEROPTIC LASER DELIVERY SYSTEM by Fiberoptic Fabrications Inc. (K120810)
  • Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber by Oberon GmbH Fiber Technologies (K140470)

Non-Clinical Testing Summary (not acceptance criteria performance):

• Bench testing: Characterization of optical transmission at given powers. Tests performed with recommended wavelength and powers up to the indicated input power. All tests "passed successfully." (No specific acceptance criteria or quantitative results are provided).
• Biocompatibility testing:
  • Cytotoxicity (ISO elution method according to ISO 10993-5, L929-Proliferation method acc. to ISO 10993-5, -12, ISO 9363-1)
  • Hemolysis (elution method acc. to ISO 10993-4, -12)
  • Chemical analysis (characterization of leachables acc. to ISO 10993-1, -12, -18)
  • Hemocompatibility (Resonance-Trombography) acc. to ISO 10993-4
  • Biological Safety-Toxicology (acc. to ISO 10993-1, 93/42/MDD (Summary))
  • "These tests have been successfully performed with different materials (all tests passed)." (No specific acceptance criteria or quantitative results are provided).

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Validation reports can be submitted on demand" for performance data. The non-clinical tests mention "passed successfully" but without specific criteria or quantitative results.
2. Sample sized used for the test set and the data provenance: Not provided for performance studies. Non-clinical tests were performed but detailed sample sizes are not given.
3. Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable, as performance studies in this format were not submitted.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a physical medical device (laser fiber), not an algorithm or AI.
7. The type of ground truth used: Not applicable, as performance studies in this format were not submitted.
8. The sample size for the training set: Not applicable, this is a physical medical device.
9. How the ground truth for the training set was established: Not applicable.

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