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The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm). The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.

The provided 510(k) summary for the Lutronic Corporation MOSAIC Laser System (K080932) indicates that the device's performance was established through a comparison to a predicate device rather than through specific acceptance criteria and a standalone human factors study or a multi-reader, multi-case study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the sense of a clinical trial with a defined sample size. The "performance data" mentioned refers to histological effects, likely from pre-clinical testing or animal studies, but the specific sample size, data provenance (country of origin), or whether it was retrospective or prospective is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the "similar histological effects" would typically be established by a pathologist reviewing tissue samples. However, no details on the number or qualifications of such experts are provided in this document.

4. Adjudication method for the test set

Not applicable. No information is provided regarding an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a laser system, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

No, a "standalone" study in the context of an algorithm's performance was not done. The device is a physical laser system, and its performance is evaluated based on its physical and biological effects.

7. The type of ground truth used

The type of ground truth used was histology for assessing "similar histological effects."

8. The sample size for the training set

Not applicable. This device is a laser system, not a machine learning algorithm. Therefore, there is no "training set" in the context of artificial intelligence.

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

Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm). The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.

This document (K070392) is a 510(k) summary for the Lutronic Corporation MOSAIC Laser System. It focuses on establishing substantial equivalence to predicate devices for its intended use in dermatological procedures requiring soft tissue coagulation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

Explanation of Implied Criteria:

The FDA 510(k) pathway is primarily about demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" are implicitly tied to showing that the new device performs as safely and effectively as the predicate, especially regarding its mechanism of action and biological response. In this case, the key criterion is the histological response.

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

The document states: "Human and animal performance data was provided..."

• Sample Size for Test Set: The specific sample sizes for human and animal subjects are not provided in this summary.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the test data, but the submitter (Lutronic Corporation) is based in the Republic of Korea. It's plausible the data originates from there or associated research facilities.
  • Retrospective or Prospective: Not explicitly stated.

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 provided in the document. For histological analysis, it would typically involve pathologists, but their number and qualifications are not disclosed.

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

This information is not provided in the document.

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 not applicable to this submission. The MOSAIC Laser System is a medical device (laser system), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging system that would involve human readers interpreting data alongside or without AI assistance. The study focuses on the histological response of tissue to the laser.

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

This is not applicable as it's not an AI algorithm. The device performance relates to the biophysical interaction of laser energy with tissue.

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

The ground truth used appears to be histological analysis/pathology. The document explicitly mentions "histological response" as the primary performance metric.

8. The sample size for the training set:

This is not applicable as it's not an AI/machine learning device that requires a training set. The "training" in this context would refer to device design, engineering, and preclinical testing, rather than an AI training set.

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

This is not applicable for the same reason as point 8.

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