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The LOTUS III Multi-Pulsed Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Based on the provided text, the device in question is the "LOTUS III Multi-Pulsed Er:YAG Laser System," which is a medical laser system. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria for a new AI/imaging device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of AI performance metrics like sensitivity, specificity, human reader improvement, ground truth establishment, training sets, etc.) is not present in this type of regulatory submission for this particular device.

This document is for a traditional medical device (a laser system) and primarily relies on non-clinical performance testing and comparison of technical characteristics to predicate devices to establish substantial equivalence. It does not involve a study of the kind typically performed for AI-powered diagnostic devices that would have the specific performance metrics and study design details requested in your prompt.

Here's why the requested information cannot be found in the provided text:

• Device Type: This is a laser system (Er:YAG laser) for general and plastic surgery and dermatology. It is a physical medical device, not an AI/software device that analyzes images or data.
• Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or performance against new, specific clinical acceptance criteria through a full-scale clinical trial like a PMA, or a clinical validation study for an AI algorithm.
• Performance Data (Section 6): The "Performance Data" section explicitly states that "Non-clinical tests" were conducted, referring to compliance with mandatory performance standards for laser products (e.g., 21 CFR 1040.10 and 1040.11), electromagnetic compliance (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), safety of laser products (IEC 60825-1, IEC 60601-2-22), risk management (ISO 14971), and biocompatibility (ISO 10993). These are engineering and safety standards, not clinical performance metrics for a diagnostic AI.
• Absence of Clinical Study Details: There is no mention of:
  • Sensitivity, specificity, AUC, or other diagnostic performance metrics.
  • Test sets, training sets, or data provenance (countries, retrospective/prospective).
  • Experts establishing ground truth, adjudication methods, or MRMC studies.
  • Standalone algorithm performance or human-in-the-loop improvement metrics.

In summary, as this document pertains to a traditional laser medical device obtaining 510(k) clearance, the requested details for AI/imaging device performance criteria and studies are not applicable and thus not present in the provided text.

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