(93 days)
Proflex™ Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho: YAG) lasers, ProFlex™ fibers may be used with any laser wavelength between 500nm and 2200mm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
The ProFlex™ Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in two fiber core diameters: 200µm & 273µm. The ProFlex™ Laser Fibers are equipped with laser launch overfill protection (spatial and angular) -- a protective, transmissive quartz ferrule, fused about the fiber input face and laser polished for high damage threshold (laser and physical), and ruggedized output tips designed for ease of transit in flexible ureteroscopes. All materials of construction are USP Class VI biocompatible and compatible with flash autoclave and EtO sterilization.
The given text is a 510(k) premarket notification for a medical device (ProFlex™ Laser Fibers). It describes the device, its intended use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy.
The "Performance Testing" section (page 7) briefly mentions:
- Bench and User Evaluation: "subject and predicate fibers were power tested in relaxed and strained (bending) configurations using a cleared surgical holmium laser."
- Results: "ProFlex™ Laser Fibers performed better than the predicate devices in all four cases... individually, on average and in consistency."
- OEM evaluation: "ProFlex has also been evaluated by one OEM holmium laser manufacturer and found to perform well."
However, this is bench testing of the device's physical properties (power transmission under stress), not a clinical study to establish diagnostic performance, human reader improvement, or stand-alone AI performance. The document focuses on demonstrating substantial equivalence to existing predicate devices based on materials, intended use, technological characteristics, and some performance characteristics (power output, damage resistance).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving that the device meets those criteria, as the provided text does not contain the necessary details for a clinical performance or diagnostic accuracy study. It specifically states that "ProFlex™ Laser Fibers are as safe, as effective and perform as well as the predicate devices," which refers to technical and material performance, not a clinical trial with human subjects or an AI component.
To answer your prompt, the document would need to describe a study with a test set, ground truth, human readers (if applicable), and diagnostic metrics like accuracy, sensitivity, specificity, AUC, etc., along with predefined acceptance criteria for these metrics. This information is absent.
§ 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.