(109 days)
The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as:
- Photocoagulation of the retina .
- t Trabeculoplasty for treatment of glaucoma
- . Iridotomy for treatment of glaucoma.
The VISULAS Trion Laser System with the VITE option is intended for use in multispot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:
- Proliferative and nonproliferative diabetic retinopathy .
- . Macular edema
- . Branch and central retinal vein occlusion
- Lattice degeneration .
- . Retinal tears and detachments
- Choroidal neovascularization associated with wet age-related macular . degeneration.
The VISULAS Trion Laser System with the VITE option is a multi-wavelength ophthalmic surgical laser intended for use in the photocoagulation of ocular tissues in treatment of diseases of the eye.
Similar to the predicate device, the VISULAS Trion Laser System (K072514) laser, energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery.
The VISULAS Trion Laser System with the VITE option includes a modified laser slit lamp (LSL) that features a multi-spot treatment cascade delivery option. The modified LSL is identical to the LSL offered with the predicate device, the VISULAS 532s Laser System with the VITE option (K100035), also manufactured by Carl Zeiss Meditec.
This 510(k) summary (K103056) describes the VISULAS Trion Laser System with the VITE option. This device is an ophthalmic surgical laser intended for photocoagulation of ocular tissues. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria with numerical targets for device performance during non-clinical testing. Instead, it refers to general functional equivalence and comparability to predicate devices.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined | The device "has been designed and tested to applicable standards including software, functionality, electrical and electromagnetic compatibility." |
| Not explicitly defined | "These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests and results but does not specify the sample size or details of the test set data. It mentions "performance data conducted using the VISULAS Trion with the VITE option."
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are described as non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set. This type of non-clinical testing typically involves engineering and functional validation against standards rather than expert-derived ground truth.
- Number of Experts: Not applicable/Not mentioned.
- Qualifications of Experts: Not applicable/Not mentioned.
4. Adjudication Method for the Test Set
Since no expert ground truth or assessment of a test set by multiple readers is described, an adjudication method is not applicable or mentioned.
- Adjudication Method: Not applicable/Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The submission relies on non-clinical engineering and functional comparability to predicate devices.
- MRMC Study: No.
- Effect Size with AI vs. without AI: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is an ophthalmic surgical laser, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's operation inherently involves a human laser surgeon.
- Standalone Performance: Not applicable.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" (if applicable in this context) would be defined by engineering specifications, applicable medical device standards, and the functional output of the predicate devices. The text states it demonstrates the "ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate devices," implying a comparison to the established performance of the predicate devices.
- Type of Ground Truth: Engineering specifications, compliance with applicable standards, and functional comparability to predicate devices.
8. The Sample Size for the Training Set
This submission describes a medical device (a laser system), not a machine learning model. Therefore, the concept of a "training set" is not applicable.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not a machine learning device, the concept of a "training set" and establishing "ground truth for the training set" is not applicable.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.