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510(k) Data Aggregation
(214 days)
Topcon Medical Laser Systems, Inc. (TMLS)
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 ** |
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(43 days)
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
532nm
- . macular edema
- age-related macular degeneration .
- . lattice degeneration
- . retinal tears and detachments
577nm
- proliferative and nonproliferative diabetic retinopathy .
- macular edema .
- choroidal neovascularization .
- . branch and central retinal vein occlusion
- . age-related macular degeneration
- . lattice degeneration
- retinal tears and detachments .
- retinopathy of prematurity .
Intended for use in the treatment of ocular pathology in the anterior segment including:
577nm
- iridotomv .
- trabeculoplasty .
The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.
This document is a 510(k) Pre-market Notification for a medical device called the PASCAL® Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the typical sense for AI/software devices.
Therefore, many of the requested sections regarding acceptance criteria and performance against those criteria, especially those pertaining to AI/software performance assessment like MRMC studies, standalone performance, and ground truth establishment, are not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" in this 510(k) is framed around substantial equivalence to predicate devices rather than quantitative performance metrics for a novel functionality. The primary acceptance criteria for a 510(k) submission are that the new device has the same intended use and technological characteristics as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.
| Acceptance Criteria Category | Specific Criteria (from text) | PASCAL® Laser Indirect Ophthalmoscope Performance (from text) |
|---|---|---|
| Intended Use | Same as predicate devices | "The PASCAL® Laser Indirect Ophthalmoscope shares the same indications for use..." (Section VII) |
| Technological | Similar design features and functional capabilities as predicate devices | "The technological characteristics of the PASCAL® Laser Indirect Ophthalmoscope are substantially equivalent to those of the predicate devices." (Section VI) |
| Characteristics | Treatment Wavelength: 577 ±2 nm or 532 ±2 nm | |
| Aiming Wavelength: 635 +10 nm | ||
| Eye Filter OD: > 5 @ 532 nm or > 5 @ 577 nm | ||
| Working Distance: 280 mm | ||
| Fiber Length: 5 meters | ||
| Aerial Spot Size: 1060 µm | ||
| Illumination Source: LED and DC Battery | ||
| Cooling System: Convection Cooled Air | ||
| Weight: 5 @ 532 mm or > 5 @ 577 nm (Matches both predicates) | ||
| Working Distance: 280 mm (Matches both predicates) | ||
| Fiber Length: 5 meters (Matches both predicates) | ||
| Aerial Spot Size: 1060 µm (Matches both predicates) | ||
| Illumination Source: LED and DC Battery (Different from predicates, but considered "similar" functionality) | ||
| Cooling System: Convection Cooled Air (Matches both predicates) | ||
| Weight: |
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