(214 days)
PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.
PASCAL® Synthesis™ TwinStar™ is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. At the physician's discretion, the system provides for a single laser spot treatment or the option of using a selectable pattern of delivering multiple laser spots simultaneously. Pattern scanning allows the physician to enhanced efficiency and reduced patient discomfort.
The PASCAL Synthesis™ Laser System (parent product to the PASCAL Synthesis Twinstar™) included 532 nm/577 nm wavelengths and was cleared via K123542. The subject device for this submission is a line extension named PASCAL Synthesis Twinstar and will include 577 nm/638 nm laser wavelengths.
The provided document is a 510(k) summary for the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in the way an AI/ML device submission would.
Therefore, many of the requested points, especially those related to acceptance criteria, specific performance metrics (like sensitivity, specificity, F1 score), sample sizes for test/training sets with ground truth, expert adjudication, or MRMC studies for AI devices, are not present in this document.
This device is a physical laser system, not an AI/ML diagnostic tool. The "performance" discussed relates to its physical characteristics and biological effects on animal tissue, not its ability to interpret medical data or assist human readers.
However, I can extract information relevant to the study that was done to support the device and map it to the closest possible aspects of your request.
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria in the form of numerical performance targets (e.g., sensitivity > X%) are stated. The study's conclusion of "similarity" is the implicit acceptance.
| Criterion/Aspect | Reported Device Performance |
|---|---|
| Novel Feature Being Compared: 638 nm red treatment laser | Similarity of Lesion Morphology: No difference in lesion morphology between the subject device (PASCAL Synthesis TwinStar 638 nm red laser) and the reference predicate (Novus Multiwavelength 647 nm red laser) was observed funduscopically or in OCT for equivalent lesion ophthalmoscopic grade. |
| Lesion Width Measurement Difference (Quantitative Comparison): | In an analysis of OCT width measurements, the difference in lesion width for the predicate and subject device was ** |
§ 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.