(90 days)
The Temperature Diagnostic Accessory is intended for use as a sensing device to measure and display the temperature of the treatment area during procedures with the ND-130 Laser.
The Temperature Diagnostic Accessory is a temperature detector which will provide the laser operator with a control panel read out of the temperature of the treatment area.
The provided documentation for the New Star Lasers Temperature Diagnostic Accessory (K973064) does not contain information regarding acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria.
Specifically, the "Nonclinical Performance Data" and "Clinical Performance Data" sections both state "None." This indicates that no studies, as typically understood for establishing performance against predefined criteria, were conducted or submitted.
The conclusion states: "The Temperature Diagnostic Accessory is substantially equivalent to other existing automatic temperature measuring accessories." This suggests that the substantial equivalence argument was based on design, intended use, and potentially basic functional comparisons without rigorous performance testing against specific acceptance criteria.
Therefore, I cannot provide the requested information in the table or address the details about sample size, ground truth, expert involvement, or comparative effectiveness studies because this information is not present in the provided 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.