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The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.

The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the "Wolf 445nm" diode laser system. This device is a laser surgical instrument, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving new clinical effectiveness or diagnostic accuracy through AI performance studies.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and AI-specific metrics are not applicable to this type of regulatory submission. This document describes a medical device, but it is not an AI/ML medical device.

However, I can extract the information that is relevant to the device's performance demonstration.

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

For this type of device (a surgical laser), acceptance criteria are primarily related to safety and performance characteristics in comparison to established predicate devices. The "reported device performance" is demonstrated through non-clinical bench testing.

Acceptance Criterion (Implicit)	Reported Device Performance
Electrical Safety (Compliance with standards)	Wolf 445nm tested according to IEC 60601-1:2005 A1:2012 and /or EN 60601-1:2006/A1:2013.
Laser Safety (Compliance with standards)	Wolf 445nm tested according to IEC 60825-1: 2014 (edition 3.0) and IEC 60601-2-22:2007/A1:2012.
Usability (Compliance with standards)	Wolf 445nm tested according to IEC 60601-1-6:2010/A1:2013 and IEC 62366:20017, AMD1:2014.
Electromagnetic Compatibility (EMC) (Compliance with standards)	Wolf 445nm tested according to IEC 60601-1-2:2014, (edition 4.0).
Software Verification & Validation (Compliance with FDA Guidance)	Software verification and validation testing conducted, and documentation provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate level of concern."
Tissue Interaction Equivalence (Safety & Effectiveness)	Comparison bench test between 445nm and 532nm laser devices demonstrated that the Wolf 445nm provides "as safe & effective performance data as a KTP Laser (532 nm) in terms of tissue interaction processes."
Cut Depth (Effectiveness)	Evaluated in histological samples. The document states the purpose was to demonstrate "as safe & effective performance data" in comparison to the predicate. Specific quantitative acceptance values are not provided, but the conclusion implies they were met.
Thermal Damage (Safety)	Evaluated in histological samples. The document states the purpose was to demonstrate "as safe & effective performance data" in comparison to the predicate. Specific quantitative acceptance values are not provided, but the conclusion implies they were met.

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

Sample Size for Test Set: Not explicitly stated in terms of number of tissue samples or specific test parameters. The document mentions "histological samples" were evaluated but does not provide details on the quantity. This was a bench test, not a clinical study involving human patients.
Data Provenance: The testing was "non-clinical" and involved "histological samples." No country of origin for the biological samples is provided. Given the manufacturer is German, it is likely the testing was conducted in Germany or a contracted lab. The testing is presumed prospective as part of the device development and submission process.

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)

The document does not specify the number or qualifications of experts who evaluated the histological samples. This is common for non-clinical bench testing where expert histological analysis is implied rather than formalized as a "ground truth" establishment for a clinical accuracy claim.

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

Not applicable/Not described. The non-clinical bench testing involved evaluating histological samples; there's no indication of a multi-reader or adjudication process as would be seen in a diagnostic imaging study.

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

No MRMC study was done. This is a laser surgical instrument, not an AI-powered diagnostic tool. The submission is for substantial equivalence to predicates for soft tissue applications.

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

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

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

For the non-clinical tissue interaction testing, the "ground truth" was established by histological evaluation of "areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage." This represents a form of pathology/histology-based assessment.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

Not applicable. As there is no training set mentioned, this question does not apply.

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