(42 days)
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.
§ 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.