(77 days)
The LaseMD LEO Laser System is indicated for use in dermatological procedures requiring the 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 (sunspots) and ephelides (freckles).
The LaseMD LEO Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) 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 LCD touch screen gives the user control over the necessary laser system parameters. The LaseMD LEO Laser System is equipped with a 658 nm aiming beam.
The provided text is a 510(k) summary for the Lutronic Corporation LASEMD LEO Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting acceptance criteria and the results of a study designed to prove the device meets specific performance criteria.
Therefore, the document does not contain most of the information requested in your prompt. Specifically:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in a table format as requested. The document discusses "performance data" as an "Animal Study Report" and "Bench Testing," implying that these were used to support substantial equivalence rather than to meet predefined acceptance criteria against specific performance metrics for the device's clinical indications.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, and standalone performance: There is no mention of these details for any clinical study. The "Animal Study Report" is mentioned to demonstrate equivalence, but no specifics about its design, participants, or outcomes proving adherence to performance metrics for the indications are provided.
- Type of ground truth, training set sample size, and how training set ground truth was established: These concepts are typically relevant for AI-powered devices or diagnostic tools. The LaseMD LEO Laser System is described as a "Laser Surgical Instrument," suggesting it's a physical device for dermatological procedures, not an AI/ML diagnostic tool. Therefore, these categories are not applicable to the information provided.
What is available:
The document states:
- 7. Performance Data:
- Animal Study Report: Included to demonstrate equivalence between the C1 tip of the Subject device and the Predicate devices. No other details are provided.
- Bench Testing: The LASEMD LEO Laser System complies with all applicable standards, including ISO 13485:2016, ISO 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility. This means the device met engineering and safety standards, not clinical performance criteria in terms of efficacy for the indications for use.
In summary, the provided document does not contain the detailed information about acceptance criteria and clinical study results that you requested, as it is a 510(k) summary focused on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and a limited animal study, rather than proving performance against specific clinical efficacy criteria in human studies.
§ 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.