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Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.

The provided text is a 510(k) summary for the Lavieen laser device. It outlines the device's characteristics, intended use, and its substantial equivalence to a predicate device. Medical device 510(k) summaries, by their nature, focus heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical study data.

Based on the provided text, there is no information provided regarding acceptance criteria for an AI/algorithm-driven device, nor is there a study described that proves an AI/algorithm meets such criteria.

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

• Device Type: The Lavieen is described as a "thulium laser, producing a pulsed beam of coherent near-infrared light." It is a physical laser surgical instrument, not an AI/algorithm-driven diagnostic or therapeutic device.
• Software Validation: While the document mentions "Software Validation" and that Lavieen contains "Basic Documentation Level software," this refers to the software controlling the laser's hardware functions (e.g., controlling power, pulse duration, repetition rate) and ensuring its safe operation, not an AI or machine learning algorithm for diagnostic or treatment planning purposes. The software validation is in accordance with FDA guidance for device software functions, which is distinct from AI/ML-specific guidance.
• Clinical Studies: The document explicitly states: "No clinical studies were considered necessary and performed." This further confirms that no clinical performance study, including one for an AI component, was conducted or presented.
• Comparison to Predicate: The substantial equivalence argument relies on comparing the technical specifications of the Lavieen laser (e.g., laser type, wavelength, power, spot size) to another legally marketed laser device (the predicate device K223727), which also appears to be a physical laser device, not an AI.

Therefore, I cannot provide the requested table or describe a study proving an AI/algorithm-driven device meets acceptance criteria because the provided text is about a physical laser device and does not contain information about an AI/algorithm or its performance study.

The prompt asks for information that is not present in the provided document. If you have a document describing an AI/algorithm-driven device and its performance study, please provide that text.

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Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (sun spots) and ephelides (freckles).

Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.

The provided text is a 510(k) Summary for the Lavieen laser system. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based medical devices or new clinical claims, are largely not present in this document. No clinical studies were deemed necessary or performed for this device.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

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

This document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance outcomes. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical characteristics and intended use.

Comparison Table for Substantial Equivalence (summarized from the document):

Reported Device Performance (from "Non-Clinical Test Summary"):

• Max output power: 10 W (This is a design specification, not a performance metric from a clinical study).
• Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
• Software Validation: Designed and developed according to a software development process, verified and validated.
• Biocompatibility: Handpiece Tip (ABS) in contact with intact skin for

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