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The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.

This document is a 510(k) Summary for the LASEMD Laser System, detailing its substantial equivalence to a predicate device. It primarily focuses on comparing the new device to an already approved one, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested items, such as a table of acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment methods, are not explicitly provided in the document as it's not a clinical performance study report for the LASEMD Laser System itself. Instead, the document relies on the equivalence to a previously cleared device.

However, I can extract information related to the device's technical specifications and how its performance was assessed in comparison to the predicate.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" for the LASEMD Laser System's clinical performance in the same way a standalone study would. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Fraxel DUAL Laser System, K130193) in terms of:

• Intended Use and Indications for Use: Must be the same.
• Technological Characteristics: Differences must be minor and not raise new questions of safety or effectiveness.
• Performance (Safety and Effectiveness): Must be as safe and effective as the predicate.

The reported device performance for substantial equivalence is primarily based on:

• Bench Testing: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
• Animal Testing: Histology confirming the treatment skin effect is the same as the predicate when used at the same energy settings.
• Clinical Testing: No new clinical data was provided for the LASEMD system itself, as it was deemed equivalent to the predicate.

Table of Device Performance (focused on comparison to predicate):

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

• Test Set Sample Size: Not applicable for a traditional clinical "test set" in this context. The animal study (histology) involved an unspecified number of animals (sample size not given).
• Data Provenance: The manufacturer, Lutronic Corporation, is based in the Republic of Korea. The animal testing location and nature (retrospective/prospective) are not specified.

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 as the document does not describe a clinical study for the LASEMD Laser System that would require expert ground truth establishment for a diagnostic test. The animal histology would likely be interpreted by veterinary pathologists, but details are not provided.

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

• Not applicable.

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 device is a laser system, not an AI-based diagnostic tool for which MRMC studies would typically be conducted.

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 system), not an algorithm.

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

• For the animal study, the "ground truth" was histology for confirming the treatment skin effect.
• For the overall substantial equivalence, the "ground truth" is that the predicate device is legally marketed and generally accepted as safe and effective for its indicated uses.

8. The sample size for the training set

• Not applicable. There's no machine learning algorithm being "trained" on a dataset for this device.

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

• Not applicable.

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