(154 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in histological response. | "Human and animal performance data was provided which documented that the histological response to the MOSAIC was substantially equivalent to the predicate device." |
| Safety and effectiveness for dermatological procedures requiring soft tissue coagulation. | Indicated for dermatological procedures requiring the coagulation of soft tissue. |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.