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The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.

The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser beam that is then emitted onto the treatment area via the handpiece connected to the optical fiber of the main body of the system. It is comprised of a main body, a handpiece connected to an optical fiber, a tip, a footswitch, and goggles for laser protection. The laser beam is emitted onto the area to be treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected to the handpiece.

When the beam contacts tissue the laser beam emits many separate microbeams and creates a microscopic treatment zone (MTZ). Thermal coagulation is then induced in the dermis using the principle of fractional photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. When the laser beam is emitted onto skin tissue, the energy of the beam is absorbed by specific tissues or chromophores such as water and is then converted into thermal energy, causing thermal damage to produce a therapeutic effect.
The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided user interface in the front of the device, which is used to easily configure optimal treatment parameters and check parameters set in the device in the current system mode.

The provided text is a 510(k) summary for the MOSAIC 3D Laser System, a surgical laser. Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied through substantial equivalence to predicate devices and the demonstration of safety and effectiveness through non-clinical and clinical testing.

The primary "performance" being evaluated for this device is its ability to induce coagulation of soft tissue and perform fractional skin resurfacing.

Here’s a table summarizing relevant device characteristics and clinical findings that demonstrate its performance:

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

• Sample Size: 15 patients.
• Data Provenance: The document does not specify the country of origin. The study was prospective, involving actual patient treatments and subsequent biopsies.

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 implies that the histological evaluation was performed by experts, but it does not specify the number of experts or their specific qualifications (e.g., dermatopathologists with certain years of experience).

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

• The document does not describe any formal adjudication method for establishing ground truth, such as a 2+1 or 3+1 consensus. It states "Histological evaluation showed signs..." which suggests a standard pathological assessment without detailing a multiple-expert consensus process.

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 is a laser surgical device, not an AI-assisted diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done and is not applicable.

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

• This is a medical device (laser system), not a standalone algorithm. Therefore, standalone algorithm performance is not applicable. The device's performance is intrinsically tied to its operation by a human user in a clinical setting.

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

• The ground truth for the clinical study was established primarily through pathology (histological evaluation of biopsies) and clinical observation of patient outcomes (resolution of side effects, absence of adverse events).

8. The sample size for the training set

• A "training set" is typically associated with machine learning or AI development. Since this is a physical medical device (laser system), the concept of a training set in that context is not applicable. The device's design and operating parameters would have been developed through engineering principles, pre-clinical testing, and potentially iterative design processes, not data-driven machine learning training.

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

• As explained in point 8, the concept of a "training set" and its associated ground truth is not applicable for this type of medical device.

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