(90 days)
Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.
Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner.
The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.
The provided FDA 510(k) clearance letter for the El.En. S.p.A. Olo Laser Device does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria for a diagnostic AI/ML device.
The document describes a laser surgical instrument, and its clearance is based on substantial equivalence to an existing predicate device (QuadroStar PRO). The "performance data" section explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" which refers to electrical safety, EMC, and software validation for the device's operational functions, not its diagnostic or an AI/ML component's performance.
Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or training set specifics from the provided text. The device described appears to be a physical medical device (laser) and not a software as a medical device (SaMD) or an AI/ML-powered diagnostic tool as indicated by the nature of the questions.
If the "Olo Laser Device" does incorporate AI/ML for diagnostic purposes, the provided FDA clearance letter is insufficient to detail how its performance was evaluated against specific diagnostic acceptance criteria. This type of information would typically be found in a separate Premarket Submission for AI/ML-enabled Medical Devices Guidance document or within the full submission details, which are not provided here.
§ 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.