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The SabreLine™ and SabreGuard™ Laser Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Coloplast surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector.

The Coloplast SabreGuard™ and SabreLine™ Laser Fibers are fiber optic laser delivery devices that transmit laser energy to soft and hard tissue in contact and non-contact mode during surgical laser procedures. The devices are 3.0 meters in length and are terminated with a SMA-905 connector on the proximal end. A laser fiber is made of silica inner core, with a primary and secondary cladding surrounded by a polymeric jacket. The laser fibers are compatible with laser systems operating in wavelengths between 500 nm - 2200 nm. The laser delivery devices are intended for use with any cleared surgical laser with a SMA-905 connector. Coloplast reference SUNXXX are equipped with a round tip, Coloplast reference SUEXXX are equipped with a radius tip; Coloplast reference SUDXXXX and RUSXXXX are equipped with a straight tip. Single use laser fibers are delivered sterile in a retail box of 3, with an instruction for use in paper version. Reusable laser fibers are delivered sterile in a retail box of 1, with an instruction for use in paper version.

This document describes the Coloplast SabreLine and SabreGuard Laser Fibers (K182831).

A table of acceptance criteria and the reported device performance is not explicitly provided in the given text. However, the document outlines the types of performance data (mechanical testing, biocompatibility, sterilization, and packaging) that were conducted to support the substantial equivalence determination. The conclusion states that the device is substantially equivalent to the predicate based on "non-clinical data provided, similar intended use, materials, design and construction, biocompatibility, and technological characteristics," implying that the performance data met unstated internal acceptance criteria for these characteristics.

Based on the provided information, I can extrapolate the types of tests done and their implied acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions "a comprehensive regimen of testing" and "mechanical testing was completed as follows to verify the product design performance," implying that sufficient samples were tested to achieve statistical significance or meet regulatory requirements for each test.
• Data Provenance: The document explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means all data is non-clinical performance data, likely derived from in vitro and benchtop testing. The origin of this data is Coloplast's internal testing.

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):

• This information is not applicable as the device is a laser fiber and its substantial equivalence was determined through non-clinical performance data, not through expert-reviewed clinical data or diagnostic accuracy studies. There was no "ground truth" to be established by experts in a diagnostic context for these tests.

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

• This information is not applicable for the same reasons above. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which were not part of this 510(k) submission.

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:

• This information is not applicable. The device is a medical instrument (laser fiber), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

• This information is not applicable as the device is a medical instrument, not an algorithm or AI system.

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

• For the non-clinical performance tests, the "ground truth" was established by engineering specifications, material standards, and validated test methods. For example, for tip diameter, the ground truth would be the design specification for the tip diameter. For biocompatibility, the ground truth would be the criteria for non-toxicity, non-sensitization, etc., as defined by ISO 10993-1.

8. The sample size for the training set:

• This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• This information is not applicable for the same reasons above.

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