(136 days)
The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The MOSAIC eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The MOSAIC eCO2 produces a beam of coherent infrared light (10.6um) and has two operation modes (Static mode and Dynamic Mode). The laser works in medical applications because 10.6um is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. This heating causes instantaneous vaporization of the target tissue. The MOSAIC eCO2 Laser System utilizes a CO2 tube to generate a laser beam with a wavelength of 10.6 um and uses a scanner handpiece. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different scan pattern.
This 510(k) summary for the Lutronic Corporation MOSAIC eCO2 Laser System states "Performance Data: None presented." This means that the submission does not include specific performance data or a study to prove the device meets acceptance criteria.
Therefore, I cannot provide the requested information, which relies on the existence of such a study and acceptance criteria within the provided document.
To be clear:
- 1. A table of acceptance criteria and the reported device performance: Not available.
- 2. Sample sized used for the test set and the data provenance: Not available.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method: Not available.
- 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 available.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- 7. The type of ground truth used: Not available.
- 8. The sample size for the training set: Not available.
- 9. How the ground truth for the training set was established: Not available.
§ 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.